로그인
RF · 2024년 · Open Access · 26
Complexing Protein-Free Botulinum Neurotoxin A Formulations: Implications of Excipients for Immunogenicity.
Martin MU, Frevert J, Tay CM ·Toxins ·2024 ·cited 10
초록 펼치기
Botulinum toxin (BT) is used therapeutically since the late 1980s. For many years, BT drugs were provided by a small group of manufacturers from Europe and the United States. As BT's use for aesthetic purposes surged, numerous new manufacturers entered the field, particularly from Korea. We want to give an overview about the rapidly expanding and diversifying BT landscape in Korea. Altogether, there are 15 Korean manufacturers of 19 BT drugs registered in Korea, mainly for aesthetic indications. There are 2 Class 1 drugs from 2 Korean manufacturers registered in Korea for export, domestic use and registered in the USA and Europe. These are PrabotulinumtoxinA (Daewoong/Evolus) and LetibotulinumtoxinA (Hugel/Croma Pharma). There are 12 Class 2 drugs from 10 Korean manufacturers registered in Korea for export and domestic use, including Neuronox®, the first Korean BT drug registered in 2006, NivobotulinumtoxinA/Innotox®, the world-wide first liquid BT type A preparation and Coretox®, the world-wide second BT drug without complexing proteins. Innotox® and Toxsta® are currently performing clinical studies in the USA. Additionally, there are 5 Class 3 BT drugs from 5 Korean manufacturers registered in Korea for export use only. 5 Korean manufacturers have 5 drug projects in Korea in advanced development phases. With this, Korea is now the country with the worldwide largest number of BT manufacturers and BT drugs. Gastric botulinum toxin therapy is gaining attention as a non-invasive treatment for obesity. However, existing studies show inconsistent results and standardized protocols remain lacking. We aimed to evaluate the efficacy and safety of a novel whole-stomach injection method emphasizing the antrum and fundus in obese patients in Japan. A total of 144 obese patients (mean age 42.3 years, mean BMI 30.3 kg/m²) underwent gastric botulinum toxin therapy at our institution between February 2023 and November 2024. Coretox (300-400 U) was injected endoscopically across the entire stomach, with increased concentration in the antrum and fundus. Patients were followed for six months post procedure. The primary outcome was the percentage of total body weight loss (%TBWL), and safety was assessed by the occurrence of complications per Clavien-Dindo classification. Mean %TBWL was 6.5% at one month, 10.2% at three months, and 12.2% at six months post treatment. No complications or adverse events were reported. The average procedure time was 5.7 minutes, and all patients completed follow-up as scheduled. We hypothesize that the observed efficacy may be partially attributed to our refined injection technique and individualized BMI-based dosage adjustment, although further controlled studies are needed to validate this approach. Gastric botulinum therapy using a novel full-stomach injection method focusing on the antrum and fundus was found to be both safe and effective in a Japanese obese population. This technique may offer a promising, minimally invasive option for obesity management. Further multicenter and long-term studies are warranted to validate and standardize this approach. The formation of neutralizing antibodies is a growing concern in the use of botulinum neurotoxin A (BoNT/A) as it may result in secondary treatment failure. Differences in the immunogenicity of BoNT/A formulations have been attributed to the presence of pharmacologically unnecessary bacterial components. Reportedly, the rate of antibody-mediated secondary non-response is lowest in complexing protein-free (CF) IncobotulinumtoxinA (INCO). Here, the published data and literature on the composition and properties of the three commercially available CF-BoNT/A formulations, namely, INCO, Coretox® (CORE), and DaxibotulinumtoxinA (DAXI), are reviewed to elucidate the implications for their potential immunogenicity. While all three BoNT/A formulations are free of complexing proteins and contain the core BoNT/A molecule as the active pharmaceutical ingredient, they differ in their production protocols and excipients, which may affect their immunogenicity. INCO contains only two immunologically inconspicuous excipients, namely, human serum albumin and sucrose, and has demonstrated low immunogenicity in daily practice and clinical studies for more than ten years. DAXI contains four excipients, namely, L-histidine, trehalosedihydrate, polysorbate 20, and the highly charged RTP004 peptide, of which the latter two may increase the immunogenicity of BoNT/A by introducing neo-epitopes. In early clinical studies with DAXI, antibodies against BoNT/A and RTP004 were found at low frequencies; however, the follow-up period was critically short, with a maximum of three injections. CORE contains four excipients: L-methionine, sucrose, NaCl, and polysorbate 20. Presently, no data are available on the immunogenicity of CORE in human beings. It remains to be seen whether all three CF BoNT/A formulations demonstrate the same low immunogenicity in patients over a long period of time. Botulinum neurotoxin type A (BoNT/A) causes muscle paralysis by blocking cholinergic signaling at neuromuscular junctions and is widely used to temporarily correct spasticity-related disorders and deformities. The paralytic effects of BoNT/A are time-limited and require repeated injections at regular intervals to achieve long-term therapeutic benefits. Differences in the level and duration of effectivity among various BoNT/A products can be attributed to their unique manufacturing processes, formulation, and noninterchangeable potency units. Herein, we compared the pharmacodynamics of three BoNT/A formulations, i.e., Botox® (onabotulinumtoxinA), Xeomin® (incobotulinumtoxinA), and Coretox®, following repeated intramuscular (IM) injections in mice. Three IM injections of BoNT/A formulations (12 U/kg per dose), 12-weeks apart, were administered at the right gastrocnemius. Local paresis and chemodenervation efficacy were evaluated over 36 weeks using the digit abduction score (DAS) and compound muscle action potential (CMAP), respectively. One week after administration, all three BoNT/A formulations induced peak DAS and maximal reduction of CMAP amplitudes. Among the three BoNT/A formulations, only Coretox® afforded a significant increase in paretic effects and chemodenervation with a prolonged duration of action after repeated injections. These findings suggest that Coretox® may offer a better overall therapeutic performance in clinical settings. Human serum albumin (HSA) has been widely used as a pharmaceutical excipient in Botulinum toxin serotype A (BoNT/A) products that are indicated for use in therapeutics and cosmetics. However, HSA as a human-derived material has some concerns, such as the potential risk of transmission of infectious agents, an insufficient supply, and difficulty in maintaining a certain quality. For those reasons, newly developed BoNT/A products (CORETOX®, Medytox, Inc., Republic of Korea) contained polysorbate 20, a non-human-derived excipient, to replace the HSA. However, most safety studies of polysorbate 20 have been conducted with non-invasive routes of administration, and thus there are a few studies on the safety of polysorbate 20 when administered intramuscularly. To secure the in vivo safety profile of polysorbate 20, a four-week repeated intramuscular dose toxicity study (0.02, 0.1, and 0.4 mg/kg, one injection every two weeks for a total of three injections) was conducted in 66 Sprague-Dawley (SD) rats. An intradermal irritation study was further conducted with 18 New Zealand White (NZW) rabbits. The toxicological evaluation of HSA (0.06 and 0.12 mg/kg) was also carried out as a comparative substance. Systemic and local toxicities were not observed in any of the SD rats or NZW rabbits based on clinical signs, body weight, hematology, clinical biochemistry, macroscopic findings on necropsy, histopathology of the injection site, and alle
DOI: 10.3390/toxins16020101 논문 보기
RF PENTO Open Access
Efficacy of adjunctive modalities during tooth extraction for the prevention of osteoradionecrosis: A systematic review and meta-analysis.
Quah B, Yong CW, Lai CWM et al. ·Oral diseases ·2024 ·cited 7
초록 펼치기
Medication-related osteonecrosis of the jaw (MRONJ) is a severe adverse effect associated with antiresorptive and antiangiogenic treatments commonly prescribed for patients with cancer or osteoporosis. The increasing prescription of these drugs, coupled with the introduction of new anti-cancer medications, has raised concerns regarding the increasing risk of MRONJ. While the precise mechanisms underlying MRONJ remain unclear and effective therapies are still lacking, two repurposed pharmacological protocols-teriparatide (TPTD) and the combination of pentoxifylline (PTX) and α-tocopherol (TOC) [PENTO protocol]-have demonstrated potential therapeutic benefits. However, large-scale clinical evidence remains insufficient. This review evaluates the therapeutic potential of these targeted drug repurposing protocols, exploring their mechanisms of action in MRONJ management and proposing a clinical application protocol for both prevention and treatment. This study also highlights the potential of drug repurposing as a rapid and cost-effective approach for MRONJ management, particularly for patients with cancer, and emphasises the need for further research on personalised and localised management strategies. Nevertheless, the current evidence base is limited by small sample sizes, heterogeneous patient populations, non-randomised study designs, and inconsistent outcome measures, precluding definitive conclusions regarding efficacy and optimal clinical use. To assess the proportion of adverse effects (AEs) associated with the use of PENTO or PENTOCLO protocols for the prevention and management of osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ). A systematic literature search was conducted across six databases (PubMed, Scopus, Embase, Web of Science, LILACS, and Cochrane Library) and gray literature, with no restrictions on date or language. Studies were eligible if they involved adults (≥ 18 years) with or at risk for ORN or MRONJ and reported AEs associated with PENTO or PENTOCLO for prevention or treatment. A proportion meta-analysis estimated the overall frequency of AEs. Subgroup analyses compared AE rates between prevention and treatment contexts and between the two regimens. Of 1,075 records screened, 9 studies met the inclusion criteria. No studies reported AEs in MRONJ patients; all focused on ORN. The pooled AE proportion was 15% (95% CI: 3.6%-11.5%; p < 0.1; I2 = 55.8%). Gastrointestinal symptoms were the most reported AEs (46.38%), followed by neurovegetative effects (18.84%). AEs were more frequent in treatment settings and more prevalent in patients using PENTOCLO (28%). The PENTO(CLO) protocols were associated with a 15% overall AE rate, predominantly gastrointestinal symptoms. AEs occurred more often during treatment and with the PENTOCLO regimen. These findings highlight the need for close monitoring and further studies to assess safety in MRONJ patients. Medication-related osteonecrosis of the jaws (MRONJ) is a complex oral condition for which no global consensus on management currently exists, underscoring the need to establish internationally accepted therapeutic protocols. The use of platelet-rich fibrin (PRF) and the adjunctive administration of pentoxifylline and tocopherol (PenTo) have shown promising preliminary results in the clinical management of MRONJ; however, robust data remain limited. The aim of this study is to analyze the outcomes of surgically treated patients with stage I and II MRONJ, incorporating PenTo as an adjuvant to platelet concentrate therapy. Furthermore, the study seeks to evaluate both clinical and radiographic outcome variables throughout the follow-up period. A controlled pharmacological clinical trial was conducted, using a standard drug regimen as the comparator. Total 20 patients diagnosed with stage I or II MRONJ were allocated into 2 groups: one group received surgical treatment combined with PRF, while the other underwent the same protocol supplemented with an adjuvant therapeutic regimen based on PenTo. Participants were recruited from the Oral Medicine Department, School of Dentistry, Universidad Católica de Córdoba. Statistically significant differences were observed in the mean duration of antiresorptive therapy, which was notably longer in patients with osteoporosis (P = .01). Zoledronic acid was the most frequently associated drug (P = .0019). The addition of PenTo to the treatment protocol was associated with improved clinical and radiographic outcomes, with statistically significant differences (P = .0138 and P = .0046, respectively). Furthermore, the diagnostic stage (I or II) showed a significant correlation with clinical improvement following treatment (P = .0294). The healing index at 15, 90, and 180 days was higher in the group receiving PenTo, with statistically significant differences at each time point (P = .0441; P = .0001; P = .0018, respectively). In oncological patients, the healing index was also higher at all follow-up stages, with clear statistical significance (P = .0294; P = .0004; P = .0042). This study contributes with patient-based evidence to support the interdisciplinary management of MRONJ. The combination of surgical treatment, PRF, and PenTo may serve to optimize and enhance clinical strategies for this condition. Osteoradionecrosis (ORN) is a severe complication of external beam radiation therapy or brachytherapy in patients with head and neck cancer. Traditional theories of its etiology have been unsuccessful in producing a standardized treatment protocol. The theory of radiation-induced fibrosis (RIF) proposes that radiation is responsible for the formation of reactive oxygen species, cytokine production, and constitutive phenotypic expression of myofibroblasts contributing to the development of ORN. The support of the RIF theory in the development of ORN is the basis for the pentoxifylline and tocopherol (PENTO) protocol for the prevention and management of ORN. The authors searched for studies published through April 6, 2025, in the following electronic databases: PubMed, Scopus, Cochrane Library, and ScienceDirect. Peer-reviewed publications were included if they were written in the English language, studied the use of the PENTO protocol, and had "pentoxifylline," "osteoradionecrosis," and "jaw" in their title, abstract, or key words. Sixty-eight articles met the inclusion criteria, 60 of which were included in this scoping review. The authors aimed to describe the pathophysiology of RIF and determine whether the PENTO protocol is effective in the treatment and prevention of ORN of the jaws, thereby warranting further research. The results of this review suggest the PENTO protocol may provide a viable method of both prevention and management of ORN. However, further research is needed to determine the efficacy and safety of the PENTO protocol. The authors emphasized the need for a well-formulated, multidisciplinary, double-blinded, prospective, randomized clinical trial to investigate the use of the PENTO protocol in the prevention and management of ORN of the jaws. Determining the most effective PENTO regimen will maximize patient healing and minimize morbidity. To evaluate the clinical use of pentoxifylline and tocopherol (PENTO), with or without clodronate (PENTOCLO), in the treatment and prevention of osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ). A literature review was conducted using PubMed from database inception to May 2025. Studies were included if they evaluated PENTO or PENTOCLO for the treatment or prevention of ORN or MRONJ. Only human studies with full-text availability were included. Data extracted included patient population, intervention details, duration, co-interventions, outcomes, and adverse events. Twenty-two studies met inclusion criteria, comprising randomized trials, prospective cohorts, and retrospective ca
DOI: 10.1111/odi.14902 논문 보기
RF LANLUMA Open Access
Intralesional hyaluronidase injection to relieve non-hyaluronic acid filler-induced vascular adverse events.
Kadouch J, Schelke L, Groh O et al. ·International journal of dermatology ·2024 ·cited 4
초록 펼치기
Injectable fillers for soft tissue augmentation stand out as one of the most favored procedures in the field of aesthetic medicine, especially in addressing the clinical signs of skin aging. Among soft tissue fillers, non-permanent fillers have been safely used in numerous medical applications for several decades. The aim of this post-market observational, open-label, uncontrolled, multicentered, prospective study (PMS) was to evaluate the effects of an injectable poly-L-lactic acid-based collagen stimulator (Lanluma®, the study product). This analysis is based on the clinical outcomes data (safety and effectiveness) collected from investigators and participants between the first injection (T0, September 2022) and 9 months thereafter (T3, June 2023) in the treatment of five body-contouring areas. Overall, 70 participants had 99 treatment sessions of the neck (31%), upper arm (20%), hand (17%), thigh (16%) and décolleté (15%). Lumps (neck, upper arm, hand) and nodules (neck, hand, thigh) were the most frequent adverse events (AEs) reported by investigators. All were treatment related. None were serious, severe or fatal. No AEs were reported following treatment of the décolleté. Both investigators and participants reported high levels of satisfaction during the nine-month follow-up period with the treatments in five body areas. These positive clinical outcomes can be attributed to a proper implementation of best practices and recommendations, and the rheological properties of the study product. This 9-month follow-up analysis should be reconsidered in light of the study's objectives for the final analysis at the 25-month follow-up. Vascular adverse events (VAEs) occurring during injections of soft-tissue fillers are still considered a challenging issue for both patients and practitioners. Hyaluronidase can dissolve hyaluronic acid (HA)-based soft-tissue fillers during a VAE. For VAEs induced by non-HA fillers, the absence of an "antidote" is regarded as exceptionally challenging. This multicenter study describes a case series of three VAEs induced by non-HA fillers, for which ultrasound-guided hyaluronidase injections were incorporated into the treatment approach. Two cases of calcium hydroxylapatite and one case of poly-L-lactic acid-induced VAEs are described, all of which were resolved without necrosis or scarring using a treatment approach with ultrasound-guided hyaluronidase injections. Unlike the mechanical hypothesis, which assumes filler particles travel antegrade to block arterioles in a large skin area, we hypothesize vasoconstriction as the pivot in VAEs. Filler injection-induced spasms could lead to long-lasting vasoconstriction of the perforator arteries stemming from the central facial arteries. Our results underscore that perforasome vasoconstriction might be the leading cause of the ischemia and subsequent necrosis in VAEs and that relaxation of these perforasomes, rather than dissolving the filler material, resolves the clinical symptoms associated with VAEs.
DOI: 10.1111/ijd.17355 논문 보기
RF Morpheus8 Open Access
The Role of Noninvasive and Minimally Invasive Techniques in Open Surgical Interventions for the Purpose of Body Contouring.
Sharkov EV ·Clinics in plastic surgery ·2024 ·cited 3
초록 펼치기
Hidradenitis suppurativa (HS) remains a therapeutically challenging disease despite expanding research and evolving systemic treatments. Energy-based modalities, such as fractional microneedling radiofrequency (FMR), are being increasingly explored as novel treatment options. To evaluate the real-world efficacy and safety of Morpheus8-based FMR treatment in patients with HS. This retrospective analysis included 25 HS patients treated at a tertiary dermatology center. Seventeen patients who completed ≥ 2 FMR sessions were included in the efficacy analysis. Outcomes were assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) and IHS4-55 (≥ 55% reduction). High-frequency ultrasound (HFUS) was used in selected cases to assess treatment response and inflammatory changes. Sixteen of the 17 patients (94.1%) evaluated for efficacy showed clinical improvement, and nine (52.9%) achieved an IHS4-55 response. The mean IHS4 reduction was 4.6 ± 2.5. The highest response rates were observed in the face, chest, and gluteal regions, while groin and thigh showed the lowest. HFUS confirmed a reduction in inflammation. Treatment was generally well tolerated, with pain cited as the most common reason for discontinuation in 3 of 25 patients (12%). FMR appears to be a safe and effective treatment option for patients with moderate-to-severe HS, including those with refractory disease and lesions in anatomically challenging areas. Clinical outcomes in our cohort were comparable to those reported for advanced systemic agents and other technology-based interventions. These findings support FMR's potential role in personalized HS management - either as a standalone intervention or in combination with systemic or procedural treatments. This study evaluated a novel approach combining low-energy Morpheus8 radiofrequency (RF) microneedling and nanofat grafting for facial rejuvenation, aiming to preserve adipose tissue while enhancing skin quality. A retrospective analysis was conducted on 20 patients (aged 20-45 y) treated with nanofat injections immediately after low-energy RF microneedling. Outcomes included Global Aesthetic Improvement Scale scores and nonsurgical parameters (pore visibility, skin luminosity, and fine wrinkles), assessed at 1, 3, and 12 months posttreatment. Pretreatment Global Aesthetic Improvement Scale scores (mean = 3.35, SD = 0.61) showed significant improvement posttreatment (mean = 1.76, SD = 0.87; P < 0.001). Sustained enhancement was observed at 3 months (mean = 1.52, SD = 0.63; P < 0.001), with 85% of patients rated as "very much improved." Blinded evaluations confirmed visible reductions in pore visibility, increased skin luminosity, and diminished fine wrinkles in nonsurgical regions (malar, perioral). No adverse events were reported. The combination of low-energy RF microneedling and nanofat grafting synergistically improves facial aesthetics by targeting regenerative and structural aging markers. Specific enhancements in nonsurgical regions underscore the value of this adjunctive approach. Larger controlled studies are warranted to establish causality. In his practice, the author has been using noninvasive devices, including Evolve X-radiofrequency-based procedure for tightening of the skin, melting of the subdermal fat deposits and muscle stimulation, all done simultaneously together and truSculpt flex-electrical muscle stimulation. Minimally invasive procedures include BodyTite, FaceTite, and AccuTite, radiofrequency-based procedures for permanent fat destruction and tightening of the skin. Morpheus8 and Morpheus8 Body are radiofrequency based-procedures for tightening of the skin. VASERlipo is an ultrasound-based procedure for liposuction and muscle definition. Vibrational type of liposuction has been used for the purpose of liposuction and muscle definition in combination with VASERlipo. A subset of facelift patients have premature redevelopment of skin laxity in the lower face and neck. Many patients seek alternatives to revision facelifts to avoid high risks and costs. Radiofrequency-assisted lipolysis (RFAL) with Radiofrequency (RF) microneedling may be alternative minimally invasive options. To evaluate the efficacy of radiofrequency energy devices for treatment of premature jowl and neck skin laxity following facialplasty. This is a single-center, prospective study of patients seeking treatment for jowl and neck skin laxity 1-5 years following facialplasty. Treatment was performed with the InMode radiofrequency AccuTite® and Morpheus8® systems. Study duration was 12 months with 6 months of follow-up. Endpoints included improvement in skin tightening assessed by blinded investigators, and investigator and subject assessment of skin appearance. Subjects also rated satisfaction with treatment and pain levels. The study protocol was completed by nine patients. Based on investigator evaluations, 33% had marked improvement at 3 months, which increased to 55% at 6-month postprocedure. Patient-reported improvement was "markedly improved" in 67%, "moderate improvement" in 11%, and "slight improvement" in 22% at 3 months. Overall patient satisfaction was rated as "very satisfied" by 33% and "satisfied" by 67% at 3 months. There were no adverse events reported. The results of this study provide supporting evidence that RFAL technology can provide a safe, minimally invasive, and effective treatment for skin laxity in the jowls and neck in patients who desire further correction after undergoing primary facelift.
DOI: 10.1016/j.cps.2023.06.005 논문 보기
RF Volnewmer Open Access
Evaluating the Efficacy of Continuous Water-Cooling 115-Watt 6.78-MHz Monopolar RF Therapy for Fine Wrinkle Reduction.
Kim J ·Plastic and reconstructive surgery. Global open ·2024 ·cited 3
초록 펼치기
Modern aesthetic trends favor noninvasive facelift procedures, shifting away from traditional surgery. This study explores the three-dimensional evaluation of facial lifting across aesthetic units using the VolNewMer (VNM) device after continuous 115-W 6.78-MHz monopolar radiofrequency (RF) therapy. A cohort of 30 Korean women underwent VNM treatment with a detailed protocol, including energy levels, cooling techniques, and stem cell media application. Lifting amount was analyzed using a three-dimensional scanner with computer program in five specific areas, including the forehead, lateral orbital rim, mid-face, low-face, and neck areas. The changes in Global Aesthetic Improvement Scale for skin texture, tightening, and lifting were surveyed. Immediate and sustained improvement was observed in the mid-cheeks and lower face area. The lifting amount of facial mid-cheek areas was 1.88 ± 0.76 mm, whereas the lifting amount of lower face areas was 1.79 ± 0.91, lateral orbital rim areas was 1.62 ± 0.99, forehead areas was 1.46 ± 1.26, and neck areas was 2.66 ± 1.40 mm immediately after the procedure. The lifting amount of mid-cheek areas was 1.93 ± 0.90 mm, whereas lower face areas was 1.67 ± 1.04, lateral orbital rim areas was 1.58 ± .072, forehead areas was 1.31 ± 0.73, and neck areas was 2.80 ± 0.78 mm 1 month after the procedure. RF treatment is emerging as a recommended noninvasive procedure for facial lifting. VNM-RF treatment showed a significant lifting effect immediately after the procedure, and the lifting effect continued 1 month later (P < 0.05). Global Aesthetic Improvement Scale skin texture was more satisfying 1 month later than immediately after, suggesting a potential correlation with collagen regeneration, indicating a lasting effect over time. Cosmetic procedures using radiofrequency (RF) technology have garnered significant attention as noninvasive approaches to skin rejuvenation and wrinkle reduction. This study investigates the efficacy of RF therapy in enhancing skin texture, firmness, and appearance. By harnessing the 6.78-MHz "VolNewMer" RF device, skin aging concerns, particularly in terms of skin roughness, laxity, and wrinkles, can be treated. This study engaged a cohort of 50 participants seeking wrinkle reduction and skin-lifting treatments. Employing noninvasive methods, the efficacy of RF therapy was evaluated immediately posttreatment and 1-month posttreatment. Skin roughness was quantified using a computer-based analysis of standardized 3D scanner images, capturing uniform lighting and angles to ensure accurate measurements. Among the 45 participants who completed the study, significant improvements in skin roughness were observed. The average roughness (Ra) value decreased from 16.71 to 11.88 arbitrary units immediately posttreatment, signifying a 28.42% enhancement. At the 1-month follow-up, the Ra value further decreased to 12.33 arbitrary units, reflecting a sustained 26.23% improvement. However, 16 participants exhibited even greater improvements at 1 month than immediate. RF therapy's profound impact on skin tightening and rejuvenation is rooted in its ability to trigger immediate collagen contraction, bolstering skin elasticity. The dual-phase process of immediate and delayed skin improvement underscores the intricate interplay between thermal stimulation and collagen remodeling. Optimal energy levels and controlled endpoint monitoring ensure safe and effective RF treatments. The use of the VolNewMer device tips and sliding technique contributes to patient comfort and treatment precision.
DOI: 10.1097/GOX.0000000000005623 논문 보기
RF MAILI Open Access
Comprehensive Evaluation of Injectability Attributes in OxiFree™ Dermal Fillers: MaiLi(®) Product Variants and Clinical Case Reports.
Micheels P, Porcello A, Bezzola T et al. ·Gels (Basel, Switzerland) ·2024 ·cited 3
초록 펼치기
The infraorbital hollow and midcheek groove ("Indian bands") are anatomically complex transition zones where ligamentous, vascular, and fat compartments converge. Safe and predictable correction with hyaluronic acid (HA) fillers requires precise, layer-specific anatomical understanding. To synthesize anatomy-based injection strategies for the infraorbital-midcheek continuum, including diagnostic triage, technique selection, complication mitigation, and ethnic-specific considerations. We conducted a narrative review based on a structured search of MEDLINE, PubMed, and Ovid databases using predefined keywords related to "Dark Circle," "Midcheek Groove," "Indian Band," "Dermal Fillers," and "Facial Anatomy." Eligible anatomical dissections, imaging-based mappings, and clinical outcome studies were qualitatively synthesized; no original patient data were collected, and no PRISMA flow diagram or quantitative meta-analysis was performed. Cannula-assisted subcision to partially release fibrous retaining bands, followed by deep support (deep malar fat pad/suborbicularis oculi fat [SOOF]) and selective superficial blending, appears to improve midcheek groove correction in published series using Maili Volume and Precise. Management of overfill or surface irregularity relies on hyaluronidase and an understanding of product rheology (elastic modulus G', cohesivity, elasticity). However, the available evidence remains heterogeneous and predominantly case-series level, with limited standardized outcomes, patient-reported measures, and long-term follow-up. An anatomy-based, layer-specific approach can enhance predictability and safety for infraorbital-midcheek rejuvenation, but current recommendations are largely experience-driven. Future work should prioritize controlled clinical validation, complication registries, and population-specific optimization of technique with robust, quantitative and patient-centered outcomes. Forehead filler injections have become a popular nonsurgical approach to enhance facial aesthetics by correcting volume deficiencies and improving contours. This anatomy-based approach emphasizes the importance of understanding the complex structural components of the forehead, including fat compartments, muscles, and vascular pathways. Proper diagnosis of forehead depressions-categorized as central, bilateral, mixed, or total types-guides targeted treatment strategies using submuscular or subdermal injection planes. Submuscular injections provide structural support, minimizing risks associated with superficial placement, such as uneven distribution and vascular complications. Techniques tailored to specific anatomic features, particularly in East Asian patients who often present with narrower foreheads, ensure natural and balanced results. Fillers used in this paper are Hyaluronic Acid (Maili, Sinclair) and Polycaprolactone (Ellanse, Sinclair). Combining fillers with botulinum toxin injections can address both dynamic and static wrinkles, achieving comprehensive facial rejuvenation while maintaining natural expressions, which is especially true for Polycaprolactone biostimulator fillers. This integrated approach optimizes aesthetic outcomes and enhances patient satisfaction by delivering smooth, contoured, and youthful forehead appearances. Level of Evidence: Level V. The shape and size of ears significantly influence facial aesthetics. In many Asian cultures, lying ears are not perceived favorably in Asian culture, leading individuals to seek surgical interventions to correct this issue. Also, due to the Ebbinghaus effect, prominent ears create a illusion of a smaller face, which is highly desired in Asians. However, surgeries to create prominent ears are invasive, can involve complications and necessitate a period of recovery. To address this concern, the authors have developed a technique utilizing hyaluronic acid (HA) injections of MAILI range (Sinclair Pharma) to enhance the appearance of lying ears. HA injections were performed at the auriculocephalic sulcus and the helix to increase the cranioauricular angle (CA) and correct lying ears. Patients showed improvements in ear prominence. The cranioauricular angle (CAA) and ear projection (EP) increased immediately after the procedure. No serious complications were noted. The injection of hyaluronic acid (HA) into the ears successfully addressed the issue of lying ears and enhanced the overall facial profile. In addition, it provided a lifting effect that contributed to a more youthful and refined appearance. This minimally invasive procedure did not necessitate any recovery time, and the results were long-lasting and highly satisfactory. Level V. Nasolabial folds significantly impact facial appearance and are a common aesthetic concern. This article reviews anatomic considerations and filler injection techniques for treating these folds, with a focus on the Korean population. The dermal filler used in this study is Maili hyaluronic acid filler (Sinclair Pharma), derived from a novel proprietary manufacturing technology known as OxiFree™ technology (Kylane Laboratoires , Switzerland). The study analyzes various injection techniques, including needle-based and cannula-based approaches, with emphasis on safe and effective practices such as the Fern leaf and Duck walk techniques. A layered injection approach addressing both superficial and deep tissue planes is examined. Three distinct types of nasolabial folds are identified: those caused by volume deficiency, tissue laxity, and muscular attachments. Each type requires a tailored treatment approach. It is not uncommon to find a combination of 2 of the types together in one person. The study highlights the importance of understanding anatomic variations, particularly the course of the facial artery in the Korean population, for safe injection practices. A thorough understanding of nasolabial fold anatomy and appropriate treatment strategies is crucial for achieving optimal outcomes in aesthetic medicine. This is especially important for the nasolabial folds, which are highly mobile, and could easily cause misplaced dermal fillers to migrate. Future research on combination intervention techniques, including botulinum toxin, lipolytic agents, and thread-lifting, may further enhance overall treatment efficacy. Facial asymmetry is a common challenge in esthetic medicine, requiring a comprehensive understanding of three-dimensional rotation patterns- X, Y , and Z axes-that significantly influence treatment outcomes. Traditional correction methods often overlook these rotational dynamics. This manuscript presents a case study of a 38-year-old Asian male patient with facial asymmetry, treated with hyaluronic acid (HA) fillers using a novel approach incorporating facial rotation concepts. By identifying the patient's clockwise facial rotation pattern and applying targeted, asymmetric filler placement, a significant improvement in facial harmony was achieved. The rheological properties of the MaiLi Extreme (Sinclair) were particularly suited for structural correction. This approach highlights the importance of rotation-based assessment and personalised treatment planning in achieving optimal esthetic outcomes. MaiLi-E is a lidocaine-containing cross-linked sodium hyaluronate gel for dermal filling. This prospective, multicenter, randomized, delayed-treatment controlled, evaluator-blinded clinical trial aims to evaluate the efficacy and safety of MaiLi-E for chin augmentation. Participants with mild-to-moderate-severe chin retrusion were enrolled and randomized (2:1) to receive MaiLi-E at study onset (MaiLi-E group) or six months later (control group). The primary efficacy endpoint was the response rate of chin retrusion improvement, defined as the percentage of participants whose China (Allergan) Chin Retrusion Scale score improved by ≥1 point from baseline, assessed by independent investigators at Month 6 post-injection for the MaiLi-E gro
DOI: 10.3390/gels10040276 논문 보기
Achieving the minimum pain experience by buccal nerve and superficial cervical plexus blocks in radiofrequency treatment.
Chen X, Han C, Li D et al. ·Journal of cosmetic dermatology ·2024 ·cited 2
초록 펼치기
Skin laxity and static wrinkles cause aesthetic concerns. Monopolar radiofrequency (RF) could produce measurable improvement. This study aims to evaluate the efficacy and safety of a novel monopolar RF device, YOUMAGIC, for skin tightening and rejuvenation treatment. In this multicenter, 6-month, assessor blind, positive parallel-controlled study, subjects were randomized to receive a single treatment with YOUMAGIC or Thermage (CPT; Solta Medical). Efficacy was mainly determined by the effective rate of facial wrinkle improvement [Global Aesthetic Improvement Scale (GAIS)] 90 days after treatment. Safety assessments were conducted through structured inquiries, adverse event diaries maintained by subjects, laboratory tests, and monitoring of vital signs. Of the 230 enrolled subjects, 212 were included in the final analysis. The proportions of subjects who achieved ≤ 3-grade on the GAIS were 100% in the treatment group and 98.10% in the control group 90 days after treatment. No significant differences were found between the treatment and control groups. No subjects experienced any serious adverse events. In conclusion, the novel monopolar RF device YOUMAGIC is clinically safe and effective for skin tightening and is not inferior to the regular RF therapeutic device. Clinical trial registry identifier: ChiCTR2400087993. URL: https://www.chictr.org.cn/showproj.html?proj=225518 2024-08-08 retrospectively registered. The online version contains supplementary material available at 10.1007/s10103-026-04841-4. Dermatological procedures improve skin changes caused by aging. However, few studies have focused on the effect of improving various skin characteristics compared with the concurrent use of cosmetics. We aimed to confirm changes in skin characteristics owing to anti-aging dermatological procedures in the short- and long-term and to determine the efficacy of the procedure when products with anti-aging and repair effects are used together. We included 42 women (mean age, 47.667 ± 3.183 years) divided into a test (n = 21) and control (n = 21) group, with no history of dermatological procedures within 3 months of the test participation date. The dermatological procedure involved a single application of Thermage treatments, and products containing repair and anti-aging ingredients were used for the test group. The skin changes were assessed using device-based measurements and image analysis up to 4 weeks post-procedure. Post-procedure side effects were alleviated 1 day after the procedure, and transepidermal water loss (TEWL) improved when the products were used together. Skin hydration, elasticity, density, fine lines, texture, and pores improved at 4 weeks after the procedure. When the test product was also used, the improvement was significantly greater, and TEWL of the face improved in the test group only. Aging-related skin characteristics were improved by Thermage, and the combined use of test products and procedures with repair and anti-aging effects improved skin characteristics. Dermatological procedures and cosmetic products have internal and external anti-aging effects on the skin, respectively, resulting in synergy. Facial aging, marked by skin laxity, wrinkling, and dyspigmentation, remains a common aesthetic concern. Few studies have investigated combination approaches to treat these concomitant components of aging. To investigate the effect of combining monopolar radiofrequency with fractional nonablative diode laser treatments to improve skin laxity, wrinkling, and dyspigmentation. A prospective, single-arm study enrolled 20 females with mild to moderate facial skin laxity and photoaging. Subjects underwent a sequence of one monopolar radiofrequency treatment (Thermage FLX, Solta, Bausch Medica, Bothell, WA) followed by 4 fractional 1440-/1927-nm nonablative diode laser treatments (Clear + Brilliant Touch, Solta, Bausch Medica). Assessments included clinical evaluations, blinded photographic assessments, and patient satisfaction scores. At the 6-month follow-up, a significant improvement was observed in Skin Laxity Grading Scale and Glogau Classification of Photoaging scale scores (1.65 ± 0.49-1.30 ± 0.47, p = .039, and 1.85 ± 0.36-1.35 ± 0.49, p = .00082, respectively). Blinded reviewers correctly identified 67% of post-treatment photographs, and 77% of participants were considered responders. No serious adverse events occurred. Monopolar radiofrequency combined with fractional diode led to significant efficacy, suggesting a safe and promising strategy for addressing facial skin laxity, wrinkles, and dyspigmentation. To evaluate the efficacy and safety of a novel monopolar RF device for skin tightening and rejuvenation treatment. Forty participants were enrolled in the study. Subjects randomized to the treatment group received a single treatment with the novel RF device (YOUMAGIC), whereas the control group received regular RF treatment (Thermage CPT; Solta Medical). Digital photographs and Antera 3D photographs were taken at baseline, 1-, 3-, and 6-month posttreatment. The depression volume of nasolabial folds (NLFs) in each visit was evaluated using the Antera 3D imaging program. The pain was evaluated by pain measurement scales immediately after treatment. Any procedure-related side effects were documented and examined. Posttreatment results were compared with the baseline; statistically significant mean depression volume (MDV) changes of NLFs were found at 1, 3, and 6 months posttreatment. No significant MDV changes were found between the treatment and control groups. No severe adverse events were reported. Our study demonstrates that the novel monopolar RF device is clinically safe and effective for skin tightening in the lower face area, and is not inferior to the regular RF therapeutic device. Thermage is a monopolar radiofrequency (RF). It has become an indispensable part of facial and body youthful methods. Although the current device is constantly improving in epidermal cooling techniques and even automatically measures the local impedance value, applying surface anesthesia can take some of the pain away caused by thermage, and the patient's severe pain in the jaw and neck areas is still difficult to resolve. The author describes how he uses the combination of the buccal nerve block (BNB) and the superficial cervical plexus block (SCPB) to improve the comfort of the patient's face and neck treatment of patients. It can improve the quality, elasticity, and texture of the skin. According to the author's knowledge of oral and maxillofacial surgery, the combination of BNB and SCPB is applied to the neck and facial analgesia. Combining the BNB and SCPB effectively provides facial and neck anesthesia. The BNB in this technique provides pain relief to the facial skin in the mandibular area and SCPB offers pain relief to the skin of the neck. RF facial rejuvenation treatment often involves the junction of the face and neck to improve the contour of the mandibular margin. Therefore, Whether the RF treatment is aimed at the face or neck, or the treatment is performed simultaneously, we advocate the block both of the buccal nerve and the superficial cervical plexus nerves to achieve perfect analgesia. Still, the dosage of anesthetic medication for the nerve block can be adjusted according to the treatment area. We applied these two nerve blocks and their combination to improve skin laxity with RF therapy for the first time.
DOI: 10.1111/jocd.16025 논문 보기
Three-dimensional Analysis of Lifting Effects after High-intensity Focused Ultrasound (Ultraformer-MPT) across Seven Facial Aesthetic Units Considering SonoAnatomy.
Kim JS ·Plastic and reconstructive surgery. Global open ·2024 ·cited 2
초록 펼치기
Eyelid sagging is a frequent concern among aging patients, yet achieving noticeable improvement with noninvasive methods remains challenging. This prospective cohort study evaluated the efficacy and safety of high-intensity focused ultrasound (HIFU) for improving upper and lower eyelid sagging. Thirty-four Korean women (aged 31-67 years) with mild to moderate eyelid laxity underwent a single session of HIFU (ULTRAFORMER MPT) using a 2.0-mm, 4-MHz probe, delivering 120 shots to the periocular region. Outcomes were assessed at 12 weeks via a four-point scale rated by blinded clinicians and patients. Eyelid length was measured using standardized photography. Mean eyelid length decreased by 0.94 ± 0.34 mm (p < 0.0001). Clinical improvement was reported by 76 % of patients and recognized by clinicians in 59 % of cases. The mean scores for overall improvement, eyelid tightening, and crow's feet reduction were 2.25 ± 0.3, 2.10 ± 0.4, and 1.95 ± 0.3, respectively. Mild pain and erythema were the only reported side effects, resolving within 3-4 days. HIFU is a safe and effective noninvasive option for improving both upper and lower eyelid sagging, with high patient satisfaction and minimal adverse effects. High-intensity-focused ultrasound (HIFU) has emerged as a noninvasive approach for facial rejuvenation, offering benefits such as collagen synthesis and subcutaneous fat reduction. However, the differential effects of varying HIFU frequencies on specific skin layers remain underexplored. To evaluate the histological effects of different HIFU frequencies and correlate these findings with patient-reported outcomes, thereby optimizing clinical applications. Histological analysis was performed on pig skin treated with HIFU at specific depths (2.0, 3.0, 4.5, and 6.0 mm) using the Ultraformer MPT device. Collagen types I and III, elastin fibers, and fat reduction were assessed using immunohistochemistry, Victoria blue staining, and Oil Red O staining. Additionally, 50 Asian female participants aged 30-60 years with skin laxity underwent HIFU treatment. Clinical outcomes were evaluated using standardized photographs, the Global Aesthetic Improvement Scale (GAIS), and a modified Rosenberg Self-Esteem Scale. Histological analysis revealed increased collagen and elastin fiber synthesis and significant fat reduction post-HIFU. Clinical outcomes corroborated these findings, with 85.3% of participants reporting overall satisfaction and 70.6% noting improvements in facial contouring. Self-esteem assessments indicated a positive psychological impact, with 64.7% of participants expressing enhanced confidence. HIFU treatment at varying frequencies induces significant histological and clinical improvements, demonstrating its efficacy for skin rejuvenation. This study underscores HIFU's dual role in enhancing physical appearance and psychological well-being, supporting its integration into patient-centric aesthetic care. This investigation delves deep into the lifting degree for each area of noninvasive facial rejuvenation through high-intensity focused ultrasound (HIFU). The study meticulously examines the lifting effects of HIFU treatment across seven distinct facial aesthetic-units, using advanced three-dimensional scanner analysis. The study examined a cohort of 50 patients treated with HIFU. Pre- and immediate posttreatment evaluations were conducted using three-dimensional scanner analysis, allowing for precise quantification of lifting effects across seven aesthetic units. Treatment protocols were tailored to leverage five cartridges with micropulsed mode options, optimizing outcomes based on sonographic anatomy. The forehead was lifted by 1.24 mm; crow's feet, 2.25; malar region, 2.46; posterior cheek, 3.40; jowl, 2.90; mandible, 3.09; and neck, 3.53. The forehead showed a lift of 1.24 mm, attributed to the thin tissue requiring a cautious approach to avoid discomfort. A lift of 2.25 mm in the crow's feet area demonstrated the efficacy of HIFU in addressing fine lines and wrinkles. Significant lift of 2.47 mm in the malar region highlights HIFU's effectiveness in addressing mid-face laxity and restoring volume to the cheeks. The most substantial lift of 3.38 mm in the posterior cheek underscores targeted energy application for enhanced lifting and contouring. Notable lifting effect of 2.90 mm in the jowl area benefits sagging along the jawline, refining facial contour. Lift of 3.10 mm in the mandible shows improvement of lower facial laxity, defining the jawline. The highest lift of 3.55 mm in the neck region addresses laxity and sagging for a defined neck profile.
DOI: 10.1097/GOX.0000000000006203 논문 보기
RF InMode Open Access
Radiofrequency and Electrical Muscle Stimulation: A Synergistic Treatment That Achieves Lipolysis and Circumferential Waist Reduction in Noninvasive Body Contouring.
Vranis NM, Ghavami A, Rohrich RJ et al. ·Aesthetic surgery journal. Open forum ·2024 ·cited 2
초록 펼치기
Background: Rosacea is a chronic facial skin disease in which persistent erythema is a significant clinical problem, often resistant to standard therapies. Intensive pulsating light (IPL) has become a recognised and effective method of treating erythema and telangiectasia. The latest recommendations emphasise the advantage of combining subjective clinical assessments with objective imaging analyses in monitoring therapy effects. Methods: A total of 20 patients with rosacea qualified for this study. They were subjected to three polychromatic light procedures (Lumecca, Inmode; wavelength of 515-1200 nm) at 21-day intervals. The skin condition was documented photographically, and the degree of erythema was assessed on the basis of the Clinician Erythema Assessment (CEA) scale and objective analysis of the skin texture, using the parameters of contrast and homogeneity of the grey level co-occurrence matrix (GLCM). Results: A series of three polychromatic light treatments yielded a significant clinical improvement in all patients. The mean CEA value decreased by 61.11%, whereas the GLCM contrast in all the analysed facial areas dropped by about 17%, and homogeneity increased by 4-5%. The effects persisted for at least three months after the treatments. A high correlation of CEA scale results with GLCM parameters (R = 0.81-0.94 for contrast; R = -0.77 to -0.83 for homogeneity) was observed. Conclusions: Three polychromatic light treatments proved to be a very effective method of reducing erythema in rosacea, confirmed by both clinical evaluation and objective imaging analysis. The effects of therapy were durable and clear. Integration of the subjective method (CEA) with GLCM analysis can be a path for future research and clinical practice in the assessment of erythematous skin lesions. Background/Objectives: "Ozempic face" is an aesthetic side effect associated with the use of the antidiabetic agent Ozempic (semaglutide), characterized by a prematurely aged and fatigued facial appearance due to rapid weight loss. Currently, treatment options for this condition are limited. In this study, we present our clinical experience with the BodyTite device, provided by InMode Italy S.r.l. (Rome, Italy). Materials and Methods: We report a case series involving 24 patients (19 women and 5 men, aged 27-65 years), treated with subdermal bipolar radiofrequency (Endotissutal Bipolar Radiofrequency) between 2023 and 2024. All patients underwent a minimum follow-up of 12 months. At the end of the follow-up period, patients rated their satisfaction on a from 0 to 10 scale, and an independent expert assessed the stability of clinical outcomes. Results: The majority of patients reported high satisfaction levels (≥8), which correlated with the independent expert's evaluation of treatment efficacy and result stability. The only observed adverse event was transient cutaneous erythema. Conclusions: "Ozempic face" is an increasingly common side effect associated with newer classes of antidiabetic medications. Although these drugs offer significant metabolic benefits, the accompanying facial volume loss and aging are often poorly tolerated by patients. Our findings suggest that subdermal bipolar radiofrequency represents a safe, low-risk, and cost-effective therapeutic option for the aesthetic management of Ozempic face. Autonomic nerves and ganglia that affect bladder sensation and detrusor contractility are present below the proximal urethra and trigone. Radiofrequency energy has been shown to potentially ablate/modulate these nerves in overactive bladder (OAB) patients. In this study, we intended to establish the safety and efficacy of transvaginal radiofrequency energy delivered via a vaginal Morpheus (Inmode) microneedling device in female patients with OAB. Women with known OAB, both primary and refractory as well as urge-predominant mixed urinary incontinence, were treated in the office setting using transvaginal detrusor nerve radiofrequency ablation to a depth of 7 mm.The primary outcome was the change in urge incontinence episodes on a 3-day voiding diary at 3 months after procedure. Secondary outcomes were the following at 1 and 3 months: the change in urinary frequency and incontinence, Incontinence Impact Questionnaire-7 (IIQ-7), Urinary Distress Inventory-6 (UDI-6), and Patient's Perception of Bladder Condition (PPBC). A pain assessment was collected immediately after the procedure and a Patient Global Impression of Improvement questionnaire was collected at 3 months. From 07/2023 to 02/2024, 32 were enrolled and 31 were followed for 3 months after treatment. Episodes of urgency incontinence, IIQ-7, UDI-6, PPBC, urinary frequency, and episodes of severe urinary urgency, had statistically significant improvement. Significant Analysis of Variance (ANOVA) testing ( P  < 0.001) was encountered with the IIQ-7, UDI-6, PPBC, urinary frequency, and urgency incontinence. No adverse events were encountered. Across all outcome metrics, the transvaginal detrusor nerve radiofrequency ablation for treatment of overactive bladder showed statistically significant improvements. Background: The techniques of choice used in the treatment of extensive vascular lesions of the face are methods based on high-energy light sources, such as lasers and IPL (intense pulsed light). The techniques commonly employed to detect blood vessel abnormalities in skin primarily rely on semi-quantitative or qualitative scales. Methods: The study was conducted on a group of 38 volunteers; a series of three treatments was performed using an IPL source (Lumecca, Inmode, Israel). The vessels' response to the high-energy light was verified using the following quantitative methods: mexametric measurements, hyperspectral imaging, and directional reflectance measurements. Results: In the mexameter measurement, statistically non-significant differences were obtained in the hemoglobin content in the skin condition prior to and following multiple intense pulsed light sessions. Studies performed using a hyperspectral camera showed that at a wavelength of 580 nm, the increase in skin reflectance after the treatment was statistically significant. Total directional reflectance measurements showed that at wavelengths of 400-540 nm and 480-600 nm, following the IPL treatment, the skin reflectance increased statistically significantly. Implementing three consecutive intense pulsed light procedures appears adequate to obtain a clinically satisfactory reduction in vascular changes in the facial skin. Mexametric measurements do not enable the assessment of the reaction of blood vessels to IPL. Conclusions: Hyperspectral imaging is an effective method for the quantitative assessment of skin vascular lesions. The best results in the assessment of vascular lesions using hyperspectral imaging are obtained at wavelengths of 420 nm and 580 nm. The hemispheric directional reflectance method allows for a quick, accurate, and repeatable assessment of vascular skin changes. Surgeons and providers in aesthetic medicine seek noninvasive devices that can be utilized for safe, efficient, and effective body contouring. Patient demand has propelled the development of novel devices that can simultaneously improve skin laxity, adipolysis along with stimulation of muscle hypertrophy. To determine the efficacy of body contouring after 3 treatments using the noninvasive Transform (InMode, Lake Forest, CA) device. A prospective, multicenter study was performed. Outcomes evaluated include: standardized caliper and ultrasound measurements of abdominal skin/soft-tissue thickness, waist circumference, histologic evaluation, patient comfort, and satisfaction assessments. Forty-four patients were successfully enrolled in the study and completed the series of 3 treatments which involved combined electrical muscle stimulation (EMS) and noninvasive bipolar radiofrequency (RF). Abdominal ultrasound measurements reveal a
DOI: 10.1093/asjof/ojae042 논문 보기
RF LANLUMA Open Access
Safety and effectiveness results of an innovative injectable poly-L-lactic acid-based collagen stimulator (Lanluma®)-Clinical outcomes at 9 months in a post-market study.
Amselem M, Fatsea D, Forte R et al. ·Journal of cosmetic dermatology ·2024 ·cited 1
초록 펼치기
Injectable fillers for soft tissue augmentation stand out as one of the most favored procedures in the field of aesthetic medicine, especially in addressing the clinical signs of skin aging. Among soft tissue fillers, non-permanent fillers have been safely used in numerous medical applications for several decades. The aim of this post-market observational, open-label, uncontrolled, multicentered, prospective study (PMS) was to evaluate the effects of an injectable poly-L-lactic acid-based collagen stimulator (Lanluma®, the study product). This analysis is based on the clinical outcomes data (safety and effectiveness) collected from investigators and participants between the first injection (T0, September 2022) and 9 months thereafter (T3, June 2023) in the treatment of five body-contouring areas. Overall, 70 participants had 99 treatment sessions of the neck (31%), upper arm (20%), hand (17%), thigh (16%) and décolleté (15%). Lumps (neck, upper arm, hand) and nodules (neck, hand, thigh) were the most frequent adverse events (AEs) reported by investigators. All were treatment related. None were serious, severe or fatal. No AEs were reported following treatment of the décolleté. Both investigators and participants reported high levels of satisfaction during the nine-month follow-up period with the treatments in five body areas. These positive clinical outcomes can be attributed to a proper implementation of best practices and recommendations, and the rheological properties of the study product. This 9-month follow-up analysis should be reconsidered in light of the study's objectives for the final analysis at the 25-month follow-up. Vascular adverse events (VAEs) occurring during injections of soft-tissue fillers are still considered a challenging issue for both patients and practitioners. Hyaluronidase can dissolve hyaluronic acid (HA)-based soft-tissue fillers during a VAE. For VAEs induced by non-HA fillers, the absence of an "antidote" is regarded as exceptionally challenging. This multicenter study describes a case series of three VAEs induced by non-HA fillers, for which ultrasound-guided hyaluronidase injections were incorporated into the treatment approach. Two cases of calcium hydroxylapatite and one case of poly-L-lactic acid-induced VAEs are described, all of which were resolved without necrosis or scarring using a treatment approach with ultrasound-guided hyaluronidase injections. Unlike the mechanical hypothesis, which assumes filler particles travel antegrade to block arterioles in a large skin area, we hypothesize vasoconstriction as the pivot in VAEs. Filler injection-induced spasms could lead to long-lasting vasoconstriction of the perforator arteries stemming from the central facial arteries. Our results underscore that perforasome vasoconstriction might be the leading cause of the ischemia and subsequent necrosis in VAEs and that relaxation of these perforasomes, rather than dissolving the filler material, resolves the clinical symptoms associated with VAEs.
DOI: 10.1111/jocd.16527 논문 보기
RF ELLANSE Open Access
Ellansé: Advanced Technology and Advantageous Selection of New Collagen Stimulating Agents for Face Rejuvenation.
Chen Q, Wang Y ·Aesthetic plastic surgery ·2024 ·cited 1
초록 펼치기
Forehead filler injections have become a popular nonsurgical approach to enhance facial aesthetics by correcting volume deficiencies and improving contours. This anatomy-based approach emphasizes the importance of understanding the complex structural components of the forehead, including fat compartments, muscles, and vascular pathways. Proper diagnosis of forehead depressions-categorized as central, bilateral, mixed, or total types-guides targeted treatment strategies using submuscular or subdermal injection planes. Submuscular injections provide structural support, minimizing risks associated with superficial placement, such as uneven distribution and vascular complications. Techniques tailored to specific anatomic features, particularly in East Asian patients who often present with narrower foreheads, ensure natural and balanced results. Fillers used in this paper are Hyaluronic Acid (Maili, Sinclair) and Polycaprolactone (Ellanse, Sinclair). Combining fillers with botulinum toxin injections can address both dynamic and static wrinkles, achieving comprehensive facial rejuvenation while maintaining natural expressions, which is especially true for Polycaprolactone biostimulator fillers. This integrated approach optimizes aesthetic outcomes and enhances patient satisfaction by delivering smooth, contoured, and youthful forehead appearances. Level of Evidence: Level V. Innovative use of a point-of-care ultrasound (POCUS) device facilitates the diagnosis and management of potential challenges associated with Ellanse treatment. Our case series of 6 patients illustrates the effectiveness of POCUS in managing challenges associated with Ellanse treatment. Ultrasound analysis is performed in all 6 patients, and management decisions are guided by ultrasound findings. Our case series of 6 patients (A, B, C, D, E & F) consists of Ellanse-treated patients. They presented problems associated with (1) facial overfilling, (2) diagnostic challenges, (3) underfilling requiring POCUS-guided treatment, (4) confirmation of nodule dissolution, and (5) pretreatment vascular assessment. Patients A and B presented with complaints of facial overfilling, and ultrasound analysis attributed the overfilling to previous autologous fat grafting and hyaluronic acid filler treatments respectively. Patient C complained of facial cheekbone prominence after receiving 26 mL of Ellanse in her entire face over 3 years. The patient was reassured that her cheek prominence was secondary to neocollagenesis following ultrasound analysis and refused further intervention. Patient D had successful dissolution of a nodule associated with Ellanse, and this was confirmed with photographs and POCUS imaging. Patient E had underdevelopment of collagen in the left midcheek following initial Ellanse treatment 3 months ago. 0.2 mL of additional Ellanse was injected with a 25G cannula under POCUS guidance to the left cheek with satisfactory correction. Patient F had three previous sessions of Ellanse treatments. She underwent vascular anatomy analysis with an ultrasound Doppler mode prior to the fourth Ellanse treatment. The presence of dense neocollagenesis following Ellanse can alter vascular patterns. A preprocedural analysis is recommended in planning subsequent treatment. Our limited case series of 6 patients provides useful insights into the effectiveness of POCUS as the initial imaging modality of choice when managing Ellanse-treated patients. POCUS imaging provides valuable diagnostic information (Patient A, B, C and D) and therapeutic purposes such as POCUS guided injection and pretreatment assessment (Patient D and E). POCUS can be the initial imaging modality of choice as it is convenient and allows clinical management to be made based on imaging findings. This study aimed to investigate the effects of hyaluronic acid rejuvenating complex, polycaprolactone, and their combination on skin wound healing, assessing their potential to accelerate tissue regeneration and optimize healing outcomes. Forty eight Wistar Albino rats were randomly divided into four groups. Group 1 received hyaluronic acid rejuvenating complex injection, Group 2 received polycaprolactone injection, and Group 3 received a combination of both. Group 4 served as the control, undergoing incision without intervention. Skin biopsies were collected at baseline, day 7, and day 14 postincision. Wound healing was evaluated histologically using hematoxylin and eosin (H&E) and Masson's trichrome staining, focusing on epithelial thickness, collagen synthesis, and inflammatory cell infiltration. The combination therapy group (Group 3) exhibited the most pronounced wound healing response, demonstrating significantly accelerated re-epithelialization, enhanced collagen deposition, and well-structured granulation tissue by days 7 and 14. Additionally, inflammatory cell infiltration was markedly reduced, indicating a faster transition from the inflammatory to the proliferative phase. Compared to single-agent treatments, the combined approach resulted in superior tissue remodeling and a more efficient healing process. The dual administration of hyaluronic acid rejuvenating complex and polycaprolactone offers a synergistic effect, significantly enhancing skin wound healing compared to monotherapies. These findings highlight the potential of combination therapy as a promising strategy for improving wound repair and tissue regeneration in aesthetic and regenerative dermatology. Ellanse is a polycaprolactone-based collagen stimulator that is rarely associated with the formation of palpable nodules. The current management of palpable nodules include triamcinolone injection, consumption of oral methotrexate, and surgical excision. The absence of an effective reversal agent that is safe has limited the popularity of Ellanse as a facial rejuvenation modality. This article presents a dual focus (1) a case series demonstrating the efficacy of the iCare technique in treating 10 nodules from Ellanse M treatment in three patients and (2) an experimental study investigating the in vitro and in vivo dissolution of Ellanse M aliquots. In the case series, nodules, which have persisted for an average of 2 years following initial Ellanse M treatment, are effectively managed with the iCare technique. The iCare technique of dissolution involves injecting a collagenase mixture that is five times the initial injected volume of Ellanse. The case series finding demonstrates the iCare technique as a viable solution in managing Ellanse-associated nodules. An allergy test is also conducted prior to injection of collagenase mixture to demonstrate the safety of collagenase mixture. An experiment is conducted by mixing 0.1 mL Ellanse M aliquots with 0.5 mL collagenase mixture (Slide X). Controls are provided by adding 0.5 mL of lignocaine 2% and adrenaline 1:80 000 (Slide L), 0.5 mL hyaluronidase (Slide H), 0.5 mL of 40 mg/mL of triamcinolone (Slide T) separately to 0.1 mL Ellanse M aliquots. Ellanse M is converted from a gel into a solution by collagenase mixture (X) while it is not affected by lignocaine and adrenaline (L), hyaluronidase (H), or triamcinolone (T). The conversion of Ellanse gel into a solution occurs within 5 min of adding the mixture. The case series demonstrates the iCare technique's efficacy in addressing delayed onset nodules associated with Ellanse treatment. The experimental study demonstrates in vitro and in vivo dissolution of injected Ellanse aliquots. This article offers a promising solution to significant issues associated with Ellanse treatment-namely, the formation of nodules and the lack of an effective fast-acting reversal agent. Nonsurgical rhinoplasty or rhinomodelation is a sought-after procedure in aesthetic practice. The current product of choice remains hyaluronic acid (HA) because of its ease of use and
DOI: 10.1007/s00266-023-03761-w 논문 보기
RF PENTO Open Access
Prophylactic Use of Pentoxifylline and Tocopherol for Prevention of Osteoradionecrosis of the Jaw after Dental Extraction in Post-Radiated Oral and Oropharyngeal Cancer Patients: An Initial Case Series.
Owosho AA, DeColibus KA, Okhuaihesuyi O et al. ·Dentistry journal ·2024 ·cited 1
초록 펼치기
Medication-related osteonecrosis of the jaw (MRONJ) is a severe adverse effect associated with antiresorptive and antiangiogenic treatments commonly prescribed for patients with cancer or osteoporosis. The increasing prescription of these drugs, coupled with the introduction of new anti-cancer medications, has raised concerns regarding the increasing risk of MRONJ. While the precise mechanisms underlying MRONJ remain unclear and effective therapies are still lacking, two repurposed pharmacological protocols-teriparatide (TPTD) and the combination of pentoxifylline (PTX) and α-tocopherol (TOC) [PENTO protocol]-have demonstrated potential therapeutic benefits. However, large-scale clinical evidence remains insufficient. This review evaluates the therapeutic potential of these targeted drug repurposing protocols, exploring their mechanisms of action in MRONJ management and proposing a clinical application protocol for both prevention and treatment. This study also highlights the potential of drug repurposing as a rapid and cost-effective approach for MRONJ management, particularly for patients with cancer, and emphasises the need for further research on personalised and localised management strategies. Nevertheless, the current evidence base is limited by small sample sizes, heterogeneous patient populations, non-randomised study designs, and inconsistent outcome measures, precluding definitive conclusions regarding efficacy and optimal clinical use. To assess the proportion of adverse effects (AEs) associated with the use of PENTO or PENTOCLO protocols for the prevention and management of osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ). A systematic literature search was conducted across six databases (PubMed, Scopus, Embase, Web of Science, LILACS, and Cochrane Library) and gray literature, with no restrictions on date or language. Studies were eligible if they involved adults (≥ 18 years) with or at risk for ORN or MRONJ and reported AEs associated with PENTO or PENTOCLO for prevention or treatment. A proportion meta-analysis estimated the overall frequency of AEs. Subgroup analyses compared AE rates between prevention and treatment contexts and between the two regimens. Of 1,075 records screened, 9 studies met the inclusion criteria. No studies reported AEs in MRONJ patients; all focused on ORN. The pooled AE proportion was 15% (95% CI: 3.6%-11.5%; p < 0.1; I2 = 55.8%). Gastrointestinal symptoms were the most reported AEs (46.38%), followed by neurovegetative effects (18.84%). AEs were more frequent in treatment settings and more prevalent in patients using PENTOCLO (28%). The PENTO(CLO) protocols were associated with a 15% overall AE rate, predominantly gastrointestinal symptoms. AEs occurred more often during treatment and with the PENTOCLO regimen. These findings highlight the need for close monitoring and further studies to assess safety in MRONJ patients. Medication-related osteonecrosis of the jaws (MRONJ) is a complex oral condition for which no global consensus on management currently exists, underscoring the need to establish internationally accepted therapeutic protocols. The use of platelet-rich fibrin (PRF) and the adjunctive administration of pentoxifylline and tocopherol (PenTo) have shown promising preliminary results in the clinical management of MRONJ; however, robust data remain limited. The aim of this study is to analyze the outcomes of surgically treated patients with stage I and II MRONJ, incorporating PenTo as an adjuvant to platelet concentrate therapy. Furthermore, the study seeks to evaluate both clinical and radiographic outcome variables throughout the follow-up period. A controlled pharmacological clinical trial was conducted, using a standard drug regimen as the comparator. Total 20 patients diagnosed with stage I or II MRONJ were allocated into 2 groups: one group received surgical treatment combined with PRF, while the other underwent the same protocol supplemented with an adjuvant therapeutic regimen based on PenTo. Participants were recruited from the Oral Medicine Department, School of Dentistry, Universidad Católica de Córdoba. Statistically significant differences were observed in the mean duration of antiresorptive therapy, which was notably longer in patients with osteoporosis (P = .01). Zoledronic acid was the most frequently associated drug (P = .0019). The addition of PenTo to the treatment protocol was associated with improved clinical and radiographic outcomes, with statistically significant differences (P = .0138 and P = .0046, respectively). Furthermore, the diagnostic stage (I or II) showed a significant correlation with clinical improvement following treatment (P = .0294). The healing index at 15, 90, and 180 days was higher in the group receiving PenTo, with statistically significant differences at each time point (P = .0441; P = .0001; P = .0018, respectively). In oncological patients, the healing index was also higher at all follow-up stages, with clear statistical significance (P = .0294; P = .0004; P = .0042). This study contributes with patient-based evidence to support the interdisciplinary management of MRONJ. The combination of surgical treatment, PRF, and PenTo may serve to optimize and enhance clinical strategies for this condition. Osteoradionecrosis (ORN) is a severe complication of external beam radiation therapy or brachytherapy in patients with head and neck cancer. Traditional theories of its etiology have been unsuccessful in producing a standardized treatment protocol. The theory of radiation-induced fibrosis (RIF) proposes that radiation is responsible for the formation of reactive oxygen species, cytokine production, and constitutive phenotypic expression of myofibroblasts contributing to the development of ORN. The support of the RIF theory in the development of ORN is the basis for the pentoxifylline and tocopherol (PENTO) protocol for the prevention and management of ORN. The authors searched for studies published through April 6, 2025, in the following electronic databases: PubMed, Scopus, Cochrane Library, and ScienceDirect. Peer-reviewed publications were included if they were written in the English language, studied the use of the PENTO protocol, and had "pentoxifylline," "osteoradionecrosis," and "jaw" in their title, abstract, or key words. Sixty-eight articles met the inclusion criteria, 60 of which were included in this scoping review. The authors aimed to describe the pathophysiology of RIF and determine whether the PENTO protocol is effective in the treatment and prevention of ORN of the jaws, thereby warranting further research. The results of this review suggest the PENTO protocol may provide a viable method of both prevention and management of ORN. However, further research is needed to determine the efficacy and safety of the PENTO protocol. The authors emphasized the need for a well-formulated, multidisciplinary, double-blinded, prospective, randomized clinical trial to investigate the use of the PENTO protocol in the prevention and management of ORN of the jaws. Determining the most effective PENTO regimen will maximize patient healing and minimize morbidity. To evaluate the clinical use of pentoxifylline and tocopherol (PENTO), with or without clodronate (PENTOCLO), in the treatment and prevention of osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ). A literature review was conducted using PubMed from database inception to May 2025. Studies were included if they evaluated PENTO or PENTOCLO for the treatment or prevention of ORN or MRONJ. Only human studies with full-text availability were included. Data extracted included patient population, intervention details, duration, co-interventions, outcomes, and adverse events. Twenty-two studies met inclusion criteria, comprising randomized trials, prospective cohorts, and retrospective ca
DOI: 10.3390/dj12040083 논문 보기
RF InMode Open Access
Methods of Quantitative Assessment of the Response of Dilated Skin Blood Vessels to High-Energy Light Treatments.
Deda A, Lipka-Trawińska A, Błońska-Fajfrowska B et al. ·Journal of clinical medicine ·2024 ·cited 1
초록 펼치기
Background: Rosacea is a chronic facial skin disease in which persistent erythema is a significant clinical problem, often resistant to standard therapies. Intensive pulsating light (IPL) has become a recognised and effective method of treating erythema and telangiectasia. The latest recommendations emphasise the advantage of combining subjective clinical assessments with objective imaging analyses in monitoring therapy effects. Methods: A total of 20 patients with rosacea qualified for this study. They were subjected to three polychromatic light procedures (Lumecca, Inmode; wavelength of 515-1200 nm) at 21-day intervals. The skin condition was documented photographically, and the degree of erythema was assessed on the basis of the Clinician Erythema Assessment (CEA) scale and objective analysis of the skin texture, using the parameters of contrast and homogeneity of the grey level co-occurrence matrix (GLCM). Results: A series of three polychromatic light treatments yielded a significant clinical improvement in all patients. The mean CEA value decreased by 61.11%, whereas the GLCM contrast in all the analysed facial areas dropped by about 17%, and homogeneity increased by 4-5%. The effects persisted for at least three months after the treatments. A high correlation of CEA scale results with GLCM parameters (R = 0.81-0.94 for contrast; R = -0.77 to -0.83 for homogeneity) was observed. Conclusions: Three polychromatic light treatments proved to be a very effective method of reducing erythema in rosacea, confirmed by both clinical evaluation and objective imaging analysis. The effects of therapy were durable and clear. Integration of the subjective method (CEA) with GLCM analysis can be a path for future research and clinical practice in the assessment of erythematous skin lesions. Background/Objectives: "Ozempic face" is an aesthetic side effect associated with the use of the antidiabetic agent Ozempic (semaglutide), characterized by a prematurely aged and fatigued facial appearance due to rapid weight loss. Currently, treatment options for this condition are limited. In this study, we present our clinical experience with the BodyTite device, provided by InMode Italy S.r.l. (Rome, Italy). Materials and Methods: We report a case series involving 24 patients (19 women and 5 men, aged 27-65 years), treated with subdermal bipolar radiofrequency (Endotissutal Bipolar Radiofrequency) between 2023 and 2024. All patients underwent a minimum follow-up of 12 months. At the end of the follow-up period, patients rated their satisfaction on a from 0 to 10 scale, and an independent expert assessed the stability of clinical outcomes. Results: The majority of patients reported high satisfaction levels (≥8), which correlated with the independent expert's evaluation of treatment efficacy and result stability. The only observed adverse event was transient cutaneous erythema. Conclusions: "Ozempic face" is an increasingly common side effect associated with newer classes of antidiabetic medications. Although these drugs offer significant metabolic benefits, the accompanying facial volume loss and aging are often poorly tolerated by patients. Our findings suggest that subdermal bipolar radiofrequency represents a safe, low-risk, and cost-effective therapeutic option for the aesthetic management of Ozempic face. Autonomic nerves and ganglia that affect bladder sensation and detrusor contractility are present below the proximal urethra and trigone. Radiofrequency energy has been shown to potentially ablate/modulate these nerves in overactive bladder (OAB) patients. In this study, we intended to establish the safety and efficacy of transvaginal radiofrequency energy delivered via a vaginal Morpheus (Inmode) microneedling device in female patients with OAB. Women with known OAB, both primary and refractory as well as urge-predominant mixed urinary incontinence, were treated in the office setting using transvaginal detrusor nerve radiofrequency ablation to a depth of 7 mm.The primary outcome was the change in urge incontinence episodes on a 3-day voiding diary at 3 months after procedure. Secondary outcomes were the following at 1 and 3 months: the change in urinary frequency and incontinence, Incontinence Impact Questionnaire-7 (IIQ-7), Urinary Distress Inventory-6 (UDI-6), and Patient's Perception of Bladder Condition (PPBC). A pain assessment was collected immediately after the procedure and a Patient Global Impression of Improvement questionnaire was collected at 3 months. From 07/2023 to 02/2024, 32 were enrolled and 31 were followed for 3 months after treatment. Episodes of urgency incontinence, IIQ-7, UDI-6, PPBC, urinary frequency, and episodes of severe urinary urgency, had statistically significant improvement. Significant Analysis of Variance (ANOVA) testing ( P  < 0.001) was encountered with the IIQ-7, UDI-6, PPBC, urinary frequency, and urgency incontinence. No adverse events were encountered. Across all outcome metrics, the transvaginal detrusor nerve radiofrequency ablation for treatment of overactive bladder showed statistically significant improvements. Background: The techniques of choice used in the treatment of extensive vascular lesions of the face are methods based on high-energy light sources, such as lasers and IPL (intense pulsed light). The techniques commonly employed to detect blood vessel abnormalities in skin primarily rely on semi-quantitative or qualitative scales. Methods: The study was conducted on a group of 38 volunteers; a series of three treatments was performed using an IPL source (Lumecca, Inmode, Israel). The vessels' response to the high-energy light was verified using the following quantitative methods: mexametric measurements, hyperspectral imaging, and directional reflectance measurements. Results: In the mexameter measurement, statistically non-significant differences were obtained in the hemoglobin content in the skin condition prior to and following multiple intense pulsed light sessions. Studies performed using a hyperspectral camera showed that at a wavelength of 580 nm, the increase in skin reflectance after the treatment was statistically significant. Total directional reflectance measurements showed that at wavelengths of 400-540 nm and 480-600 nm, following the IPL treatment, the skin reflectance increased statistically significantly. Implementing three consecutive intense pulsed light procedures appears adequate to obtain a clinically satisfactory reduction in vascular changes in the facial skin. Mexametric measurements do not enable the assessment of the reaction of blood vessels to IPL. Conclusions: Hyperspectral imaging is an effective method for the quantitative assessment of skin vascular lesions. The best results in the assessment of vascular lesions using hyperspectral imaging are obtained at wavelengths of 420 nm and 580 nm. The hemispheric directional reflectance method allows for a quick, accurate, and repeatable assessment of vascular skin changes. Surgeons and providers in aesthetic medicine seek noninvasive devices that can be utilized for safe, efficient, and effective body contouring. Patient demand has propelled the development of novel devices that can simultaneously improve skin laxity, adipolysis along with stimulation of muscle hypertrophy. To determine the efficacy of body contouring after 3 treatments using the noninvasive Transform (InMode, Lake Forest, CA) device. A prospective, multicenter study was performed. Outcomes evaluated include: standardized caliper and ultrasound measurements of abdominal skin/soft-tissue thickness, waist circumference, histologic evaluation, patient comfort, and satisfaction assessments. Forty-four patients were successfully enrolled in the study and completed the series of 3 treatments which involved combined electrical muscle stimulation (EMS) and noninvasive bipolar radiofrequency (RF). Abdominal ultrasound measurements reveal a
DOI: 10.3390/jcm13247547 논문 보기
Efficiency of Combining Heated Eye Mask with Intense Pulsed Light Therapy as a Treatment Option for Evaporative Dry Eye Disease.
Pac CP, Ferrari F, Mercea N et al. ·Romanian journal of ophthalmology ·2024 ·cited 1
초록 펼치기
Background: The techniques of choice used in the treatment of extensive vascular lesions of the face are methods based on high-energy light sources, such as lasers and IPL (intense pulsed light). The techniques commonly employed to detect blood vessel abnormalities in skin primarily rely on semi-quantitative or qualitative scales. Methods: The study was conducted on a group of 38 volunteers; a series of three treatments was performed using an IPL source (Lumecca, Inmode, Israel). The vessels' response to the high-energy light was verified using the following quantitative methods: mexametric measurements, hyperspectral imaging, and directional reflectance measurements. Results: In the mexameter measurement, statistically non-significant differences were obtained in the hemoglobin content in the skin condition prior to and following multiple intense pulsed light sessions. Studies performed using a hyperspectral camera showed that at a wavelength of 580 nm, the increase in skin reflectance after the treatment was statistically significant. Total directional reflectance measurements showed that at wavelengths of 400-540 nm and 480-600 nm, following the IPL treatment, the skin reflectance increased statistically significantly. Implementing three consecutive intense pulsed light procedures appears adequate to obtain a clinically satisfactory reduction in vascular changes in the facial skin. Mexametric measurements do not enable the assessment of the reaction of blood vessels to IPL. Conclusions: Hyperspectral imaging is an effective method for the quantitative assessment of skin vascular lesions. The best results in the assessment of vascular lesions using hyperspectral imaging are obtained at wavelengths of 420 nm and 580 nm. The hemispheric directional reflectance method allows for a quick, accurate, and repeatable assessment of vascular skin changes. Background and objectives: The study aimed to establish the efficiency of combining the Posiforlid heated eye mask with intense pulsed light therapy (IPL), as a treatment strategy for evaporative dry eye disease. Materials and methods: This study included 110 patients, respectively 220 eyes, diagnosed with evaporative dry eye disease, patients between 18 and 86 years old, divided into two study groups. The first one, the control group, consisted of 73 patients treated with IPL therapy, and the second of 37 patients, who underwent IPL therapy associated with Posiforlid heated eye mask. Subjective evolution was assessed using an eye fitness test (EFT) regarding symptomatology. Objective assessment of the ocular surface was performed by tear film stability evaluation (TFSE), non-invasive first break-up time (NIFBUT), non-invasive average breakup time (NIABUT), ocular surface inflammatory evaluation (OSIE), measuring of the central tear meniscus height (CTMH) and thinnest tear meniscus height (TTMH). The assessment was performed at the beginning of the IPL treatment, during the IPL sessions, at the end of the IPL treatment, and afterward, at 3, 6, and 12 months. Results: Tear film stability has increased in both study cases, but no statistically significant difference was observed between the two groups studied. For the control group, tear film stability evaluation (TFSE) started from 310.56 ± 389.54 at baseline (time 1 presentation) to 114.40 ± 122.90 after 12 months, and for the heated mask group, from 391.11 ± 456.45 (time 1 presentation) to 97.38 ± 105.98 after 12 months. NIABUT increased from 10.72 ± 4.90 seconds to 14.79 ± 3.72 seconds in the control group, and from 11.11 ± 5.08 seconds to 15.84 ± 2.26 seconds in the second group. OSIE decreased, as expected, from 7.18 ± 7.93 percent in the control group to 2.24 ± 2.38 percent after 12 months and from 7.42 ± 7.77 percent to 2.47 ± 2.50 percent in the Posiforlid group. Although significantly lower, there was no significant difference between the two studied groups. No statistically significant changes were registered in the studied quantitative parameters. Using the EFT test, great improvements were registered regarding symptomatology, with a score increasing from 29.99 ± 8.60 to 39.10 ± 5.08 in the control group and from 27.35 ± 9.24 to 38.35 ± 4.62 in the other group. Again, the same statistical result was registered on this variable. Conclusions: The improvement of tear film stability, ocular surface inflammatory condition, and subjective symptoms during IPL therapy sessions and the first year of observation after the completion of the treatment was not necessarily increased by the additional use of a heated eye mask. Abbreviations: IPL = intense pulsed light therapy, EFT = eye fitness test, NIFBUT = non-invasive first break-up time, NIABUT = non-invasive average break-up time, OSIE = ocular surface inflammatory evaluation, TFSE = tear film stability evaluation, CTMH = central tear meniscus height, TTMH = thinnest tear meniscus height, DED = dry eye disease, MGD = meibomian gland dysfunction, SD = standard deviation. To evaluate the effect of IPL (intense pulsed light) treatment in patients with meibomian gland dysfunction (MGD). Clinical data of 25 patients with MGD who underwent IPL treatment at the department of ophthalmology of Ludwig-Maximilians-University between 2016 and 2018 were analyzed. Demographics, clinical history, examination findings (eyelid vascularization, meibomian gland findings, conjunctival redness, tear film break-up time [TFBUT], corneal staining (Oxford grading scale [OGS]), and subjective patients' findings (including ocular surface disease index [OSDI]) were collected from each visit (D1, D15, D45, D75). All included patients underwent three sessions of IPL treatment in both eyes (D1, D15, D45). There was a significant improvement after IPL treatment (D75) in TFBUT (p < 0.001), corneal staining (OGS) (p < 0.001), conjunctival redness (p < 0.001), lid margin edema (p < 0.001) and redness (p < 0.001), meibum quality (p < 0.001), lid margin telangiectasia (p = 0.005), meibomian gland obstruction (p = 0.001), and OSDI score (p = 0.004). Even after the first IPL session, significant improvements in TFBUT (p < 0.001), corneal staining (OGS p < 0.001), conjunctival redness (p < 0.022), lid margin edema (p < 0.001) and redness (p < 0.016), meibum quality (p = 0.014), and OSDI score (p < 0.013) were noted. There were no relevant negative side effects. Subgroup analysis for age, sex, duration or severity of disease, and associated diagnosis of rosacea showed no significant difference in effectiveness. IPL is an effective and safe treatment for patients with MGD, which can be used as a supportive therapeutic option. ZIEL: Beurteilung der Wirkung der IPL-Therapie (IPL: Intensive pulsed Light) bei Patienten mit Meibomdrüsendysfunktion (MDD). Analysiert wurden die Daten von 25 Patienten mit MDD, die zwischen 2016 und 2018 in der Abteilung für Augenheilkunde der LMU mittels IPL behandelt wurden. Demografische Daten, klinische Anamnese sowie Untersuchungsbefunde (Lidrandvaskularisation, Meibomdrüsenbefunde, Bindehautrötung, Tränenfilmaufrisszeit (TFBUT), Hornhautoberflächenfärbung (Oxford Grading Scale [OGS]) und subjektive Symptome (einschließlich des Ocular Surface Disease Index [OSDI]) wurden bei jedem Besuch erhoben (D1, D15, D45, D75). Alle Patienten erhielten eine IPL-Behandlung in 3 Sitzungen an beiden Augen (D1, D15, D45). Am Ende der IPL-Behandlung (D75) zeigte sich eine signifikante Verbesserung von TFBUT (p < 0,001), Hornhautoberflächenfärbung (OGS) (p < 0,001), Bindehautrötung (p < 0,00
DOI: 10.22336/rjo.2024.29 논문 보기
RF DERMAV Open Access
Clinical and Optical Coherence Tomography Correlation of Vascular Conditions Treated With a Novel, Variable-Sequenced, Long-Pulsed, 532 and 1,064 nm Laser With Cryogen Spray Cooling.
Wang JV, Bajaj S, Himeles JR et al. ·Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] ·2024
초록 펼치기
Patients frequently seek laser treatment for vascular conditions. More recently, a novel 532 and 1,064 nm laser was developed to offer greater flexibility. A prospective clinical trial evaluated the safety and efficacy of a novel, variable-sequenced, long-pulsed, 532 and 1,064 nm laser with cryogen spray cooling (DermaV, Lutronic, South Korea). Subjects with vascular conditions were enrolled for laser treatments. Clinical evaluations and optical coherence tomography (OCT) imaging were performed. Thirteen subjects were enrolled. The mean age was 51.3 years, and 92.3% were women. Fitzpatrick skin types I-IV were included. Treatment indications included broken blood vessels, rosacea, port-wine birthmark, and spider angioma. For physician investigator grading, all subjects were graded as improved at both 30-day and 90-day follow-up. Blinded photographic review by 3 independent, blinded physicians had a mean of 89.7% of cases selected correctly with at least 2 of 3 in agreement for 100.0% of cases. Optical coherence tomography imaging showed significant reductions in vessel density ( p = .018) and diameter ( p = .003) of the superficial vascular plexus. No serious adverse events occurred. A novel, variable-sequenced, long-pulsed, 532 and 1,064 nm laser with cryogen spray cooling can safely and effectively improve vascular conditions and lesions as determined by both clinical and OCT evaluation. Patients frequently seek treatment for vascular and pigmented lesions. More recently, a novel, variable-sequenced, long-pulsed, 532-nm and 1,064-nm laser with cryogen spray cooling was developed to offer greater flexibility in treatments. A prospective clinical trial evaluated the safety and efficacy of a novel, variable-sequenced, long-pulsed, 532-nm and 1,064-nm laser with cryogen spray cooling (DermaV, Lutronic, South Korea). Subjects with vascular and/or pigmented lesions were enrolled and underwent laser treatments. Twenty-three subjects were enrolled with vascular lesions (39.1%), pigmented lesions (17.4%), and both (43.5%). Mean age was 53.1 years, and 91.3% were women. Fitzpatrick skin types II-IV were included. All subjects were treated with 532 nm, and 4 were also treated with 1,064 nm. According to 4 blinded physician reviewers, correct before and after photographs were selected in 94.7%, 92.1%, 84.2%, and 76.3% of cases. Overall, 86.8% were responders, meaning that at least 3 of 4 reviewers agreed. For Global Aesthetic Improvement Scale, improvement occurred in 81.6%, 81.6%, 81.6%, and 76.3% of cases. No serious adverse events occurred. Overall, 87.0% of subjects reported being very satisfied or satisfied. A novel, variable-sequenced, long-pulsed, 532-nm and 1,064-nm laser with cryogen spray cooling can safely and effectively improve vascular and pigmented lesions.
DOI: 10.1097/DSS.0000000000004057 논문 보기
RF Volnewmer Open Access
Comparative Three-dimensional Analysis of Facial Lifting Effects across Five Aesthetic Units following Continuous Radiation 115-Watt 6.78-MHz Monopolar Radiofrequency Therapy.
Kim J ·Plastic and reconstructive surgery. Global open ·2024
초록 펼치기
Modern aesthetic trends favor noninvasive facelift procedures, shifting away from traditional surgery. This study explores the three-dimensional evaluation of facial lifting across aesthetic units using the VolNewMer (VNM) device after continuous 115-W 6.78-MHz monopolar radiofrequency (RF) therapy. A cohort of 30 Korean women underwent VNM treatment with a detailed protocol, including energy levels, cooling techniques, and stem cell media application. Lifting amount was analyzed using a three-dimensional scanner with computer program in five specific areas, including the forehead, lateral orbital rim, mid-face, low-face, and neck areas. The changes in Global Aesthetic Improvement Scale for skin texture, tightening, and lifting were surveyed. Immediate and sustained improvement was observed in the mid-cheeks and lower face area. The lifting amount of facial mid-cheek areas was 1.88 ± 0.76 mm, whereas the lifting amount of lower face areas was 1.79 ± 0.91, lateral orbital rim areas was 1.62 ± 0.99, forehead areas was 1.46 ± 1.26, and neck areas was 2.66 ± 1.40 mm immediately after the procedure. The lifting amount of mid-cheek areas was 1.93 ± 0.90 mm, whereas lower face areas was 1.67 ± 1.04, lateral orbital rim areas was 1.58 ± .072, forehead areas was 1.31 ± 0.73, and neck areas was 2.80 ± 0.78 mm 1 month after the procedure. RF treatment is emerging as a recommended noninvasive procedure for facial lifting. VNM-RF treatment showed a significant lifting effect immediately after the procedure, and the lifting effect continued 1 month later (P < 0.05). Global Aesthetic Improvement Scale skin texture was more satisfying 1 month later than immediately after, suggesting a potential correlation with collagen regeneration, indicating a lasting effect over time. Cosmetic procedures using radiofrequency (RF) technology have garnered significant attention as noninvasive approaches to skin rejuvenation and wrinkle reduction. This study investigates the efficacy of RF therapy in enhancing skin texture, firmness, and appearance. By harnessing the 6.78-MHz "VolNewMer" RF device, skin aging concerns, particularly in terms of skin roughness, laxity, and wrinkles, can be treated. This study engaged a cohort of 50 participants seeking wrinkle reduction and skin-lifting treatments. Employing noninvasive methods, the efficacy of RF therapy was evaluated immediately posttreatment and 1-month posttreatment. Skin roughness was quantified using a computer-based analysis of standardized 3D scanner images, capturing uniform lighting and angles to ensure accurate measurements. Among the 45 participants who completed the study, significant improvements in skin roughness were observed. The average roughness (Ra) value decreased from 16.71 to 11.88 arbitrary units immediately posttreatment, signifying a 28.42% enhancement. At the 1-month follow-up, the Ra value further decreased to 12.33 arbitrary units, reflecting a sustained 26.23% improvement. However, 16 participants exhibited even greater improvements at 1 month than immediate. RF therapy's profound impact on skin tightening and rejuvenation is rooted in its ability to trigger immediate collagen contraction, bolstering skin elasticity. The dual-phase process of immediate and delayed skin improvement underscores the intricate interplay between thermal stimulation and collagen remodeling. Optimal energy levels and controlled endpoint monitoring ensure safe and effective RF treatments. The use of the VolNewMer device tips and sliding technique contributes to patient comfort and treatment precision.
DOI: 10.1097/GOX.0000000000006137 논문 보기
RF NEURAMIS Open Access
Efficacy and safety of different hyaluronic acid fillers on cheek volume augmentation: systematic review and network meta-analysis.
Elrosasy A, Abo Zeid M, Hindawi MD et al. ·Archives of dermatological research ·2024
초록 펼치기
Various rejuvenation surgeries, including hyaluronic acid (HA) fillers, aim to address mid-face volume loss. However, literature on the comparative efficacy and safety of different HA fillers for the zygomatic area remains limited. This systematic review and network meta-analysis (NMA), adhering to NMA PRISMA 2020 and Cochrane guidelines. Searches were conducted on different bases. Eligible studies included patients with mid-face volume loss undergoing HA interventions. The primary outcome was the Global Aesthetic Improvement Scale (GAIS) at different time points and the incidence of adverse events. Among 1742 articles, six randomized controlled trials (RCTs) met the inclusion criteria with a total of 579 patients. The studies evaluated Giselleligne, VYC-20, Neuramis Lidocaine and ART-Filler. Results showed that Giselleligne demonstrated superior safety compared to VYC-20, ART-Filler and Neuramis-Lidocaine (Risk Ratios (RR) = 0.27, 95% Confidence interval (CI) [0.14; 0.54]), (RR = 0.36, 95% CI [0.17; 0.75], & RR = 0.22, 95% CI [0.07; 0.67]) respectively However, there were no significant differences in the Global Aesthetic Improvement Scale Assessment (GAIS) scores between HA fillers at 1, 3, and 6 months. While no significant differences were observed in efficacy among HA fillers, Giselleligne emerged as a potentially safer option for the cheeks volume restoration. The study emphasizes the need for further well-designed RCTs to explore the long-term safety and durability of HA fillers. These findings contribute valuable insights for clinicians and patients in making evidence-based decisions regarding mid-face rejuvenation options. Hyaluronic acid (HA)-based dermal fillers have been approved for various clinical indications, both cosmetic and medical. Previous studies that have assessed the performance of HA dermal fillers have primarily focused on evaluating filler durability, and only a few have studied their distribution within the tissues. The present study aimed to compare tissue integration of various types of HA dermal fillers having different clinical indications and varying injection depths. To examine the local inflammatory response and distribution pattern of 14 HA dermal fillers (six Neuramis [NEU], one Belotero [BEL], three Juvéderm [JUV], and four Restylane [RES]), each product was injected intradermally and subcutaneously at the backs of two male miniature pigs. Histopathological evaluation and visual examination of the tissue sections were conducted 1 and 4 weeks after injection. Mean inflammatory cell infiltration scores tended to be lower in response to fillers from the NEU and BEL series than to those from the JUV and RES series after intradermal and subcutaneous injection. Furthermore, the inflammatory response to fillers with higher physicochemical properties specifically designed for injection into deeper layers of the skin tended to be slightly higher than those designated for injection into more superficial layers. There was no significant difference in tissue integration according to clinical indication and injection depth, although fillers from the NEU and BEL series exhibited better tissue integration than those from the JUV and RES series. Our findings not only suggest that the local inflammatory response and tissue integration differ across HA dermal filler products, but also that these parameters could vary according to the recommended clinical indication and injection depth of the products. The long-term effectiveness and safety of hyaluronic acid fillers in mid-face volume restoration in Asians remain unclear. The objective of this study was to compare the long-term effectiveness and safety of Neuramis Volume Lidocaine (SHAPE-NVL) and Juvederm Voluma with Lidocaine (VYC-20L) in mid-face volume restoration in Asians. Overall, 88 Korean subjects with moderate-to-severe age-related mid-face volume deficit on the Mid-Face Volume Deficit Scale (MFVDS) received SHAPE-NVL on one side and VYC-20L on the contralateral side of the face. Of the 81 subjects who completed the 48-week primary study, 69 subjects were enrolled in an extension study lasting 104  weeks. MFVDS score and global aesthetic improvement were assessed at each visit. Response was defined as a ≥1-point reduction in MFVDS. At weeks 36 and 48, the responder rates for SHAPE-NVL were 81.93% and 80.72%, while those for VYC-20L were 85.54% and 81.92%, respectively. At the 104-week visit, the responder rates were 73.91% and 72.46% for SHAPE-NVL and VYC-20L, respectively. No subjects experienced any serious adverse events during the trial. SHAPE-NVL and VYC-20L showed comparable longevity and safety in mid-face volume restoration over 2  years in Asians. Both had durable effects for up to 2  years with minimal safety concerns. There have been few studies using hyaluronic acid fillers to restore mid-face volume deficit especially in Asians. This study compared the efficacy and safety of two highly cohesive hyaluronic acid fillers, Neuramis® Volume Lidocaine and Juvederm® Voluma® with Lidocaine (VYC-20L), for temporary restoration of mid-face volume in Asians. A total of 88 subjects with moderate to severe age-related mid-face volume deficit on the Mid-Face Volume Deficit Scale (MFVDS) received Neuramis® Volume Lidocaine on one side and VYC-20L on the other side of the face. Response was defined as a ≥1 point reduction in MFVDS at 24 weeks after the injection by photographic assessment. Secondary end points included photographic and live assessments of MFVDS and its changes at week 4, 12, and 24; global aesthetic improvements, as assessed by the investigators and the subjects at each visit; and the proportion of subjects who received touch-up treatment. The response rates of the sides treated with Neuramis® Volume Lidocaine and VYC-20L were identical (96.39%) at week 24, demonstrating that Neuramis® Volume Lidocaine was noninferior to VYC-20L. Photographic and live assessments of MFVDS and its changes, global aesthetic improvement, and the proportion of subjects who received touch-up treatment did not differ significantly during follow-up. Neuramis® Volume Lidocaine was not inferior to VYC-20L in temporarily restoring mid-face volume at 24 weeks after treatment. Both of these highly cohesive hyaluronic acid fillers can be used effectively and safely for the correction of mid-face volume loss in Asians. Hyaluronic acid dermal fillers are most frequently used for unwanted wrinkles. Recently, lidocaine has been incorporated into hyaluronic acid fillers to reduce injection discomfort. A randomized, multicenter, double-blind, intraindividual trial was designed to compare a new lidocaine-containing monophasic hyaluronic acid filler (Neuramis Deep Lidocaine) with a lidocaine-containing biphasic hyaluronic acid filler (Restylane Perlane-L) in moderate to severe nasolabial folds. Fifty-eight patients with moderate to severe nasolabial folds were randomized to an injection of Neuramis or Perlane-L in the left or right side of the face. Clinical efficacy and safety were assessed by blinded investigators, independent expert panels, and patients based on the Wrinkle Severity Rating Scale and the Global Aesthetic Improvement Scale at weeks 8, 16, and 24 after the injection. Wrinkle Severity Rating Scale improvement from baseline with Neuramis (1.64 ± 0.74) was significantly greater than with Perlane-L (1.45 ± 0.54) at week 24 (p < 0.05). The mean Global Aesthetic Improvement Scale score at week 24 was 2.36 ± 0.55 for Neuramis and 2.00 ± 0.50 for Perlane-L (p < 0.05). However, the difference in pain reduction between Neuramis- and Perlane-L-treated sides was not statistically significant. The efficacy and safety of Neuramis are comparable to those of Perlane-L in Wrinkle Severity Rating Scale and Global Aesthetic Improvement
DOI: 10.1007/s00403-024-03567-z 논문 보기
RF PICOHI Open Access
Evaluation of the effectiveness of picosecond KTP and fractional thulium lasers on pigmented-type periorbital dark circles.
AlRamthan A, Shaban M, AlSaqer F et al. ·Lasers in medical science ·2024
초록 펼치기
To determine the effectiveness of picosecond KTP in reducing peri-ocular dark circles caused mainly by excessive pigmentation and to compare Picosecond KTP with Thulium laser ability in reducing the intensity and extent of peri-ocular dark circles. This split-face prospective study included twelve women with periorbital dark circles (pigmented or mixed-pigmented type). The left lower eyelid was treated using the PicoHi machine (HIRONIC Ltd), a full beam Q-switched Nd-YAG provided by KTP crystal (523 nm) at settings of 0.3 J/cm2, 5 mm, 5 Hz, and 300 Ps. Whereas the right lower eyelid was treated using the Lavieen machine (WON TECH Co., Ltd), a fractional Thulium laser (1927 nm) at setting 1320 mJ/cm2, 30 × 15 mm, 1500 microseconds. Patients received a series of 3 treatment sessions, given at 4-week intervals. The 532-nm full beam Q-switched KTP and fractional Thulium lasers were more likely to induce post-inflammatory hyperpigmentation rather than decrease the pigmentation. The risk is higher with a Q-switched KTP laser, which may be attributed to the skin tone of the participants. Nonetheless, some improvement in the pigmented type of PDCs, although not detected clinically, was documented by the VISIA software. No solid conclusion can be drawn from the results of the study. Picosecond KTP and Thulium lasers may have a role in reducing PDCs yet more studies should be performed in order to determine the exact impact these lasers have.
DOI: 10.1007/s10103-024-04095-y 논문 보기
RF OPTILIGHT Open Access
Perfluorohexyloctane ophthalmic solution (Miebo) for dry eye disease.
·The Medical letter on drugs and therapeutics ·2024
초록 펼치기
Dry eye disease (DED), also known as dry eye syndrome, is a multifactorial ocular surface disease. The aim of this review is to present the details of currently approved and upcoming treatment options for DED in a nutshell. We conducted a thorough literature search using PubMed and searched US FDA website, clinicaltrials.gov, and data available in public domain for currently approved and upcoming treatment options for DED. Currently, the US Food and Drug Administration (FDA)-approved medical treatments for treatment of DED include cyclosporine formulations (RESTASIS® [cyclosporine 0.05% ophthalmic emulsion], VEVYE® [cyclosporine 0.1% ophthalmic solution], and CEQUA™ [cyclosporine 0.09% ophthalmic solution]), XIIDRA® (lifitegrast), a leukocyte function-associated antigen-1 (LFA-1)/intracellular adhesion molecule-1(ICAM-1) inhibitor, EYSUVIS™ (loteprednol etabonate ophthalmic suspension 0.25%), a corticosteroid, and MIEBO™ (perfluorohexyloctane ophthalmic solution), a semifluorinated alkane. TYRVAYA™ (varenicline solution nasal spray), a cholinergic agonist, is another formulation approved for the treatment of the signs and symptoms of DED. The medical devices approved for treating DED due to meibomian glands dysfunction (MGD) include Lumenis OptiLight™ (intense pulsed light [IPL] device), TearCare® system, and TearScience™ LipiFlow™ thermal pulsation system. Punctal plugs are another treatment option approved for management of DED. There are hundreds of clinical studies evaluating newer treatments for managing the signs and symptoms. Cyclosporine formulations TJO-087 (cyclosporine A nanoemulsion 0.08%), SCAI-001 eye drops (cyclosporine 0.01%, 0.02%) are being evaluated against RESTASIS® and other approved treatments. The potential treatments being assessed include IC 265, OK-101, PL9643, SYL1001 (tivanisiran), SHJ002, OXERVATE® (cenegermin-bkbj ophthalmic solution 0.002%), HBM9036 (tanfanercept ophthalmic solution), OCS-02 (licaminlimab), MIM-D3 (tavilermide ophthalmic solution 5%), AR-15,512, BRM421, reproxalap, and AZR-MD-001 (selenium sulphide ointment 0.5%). The pathophysiology of DED is complex and multifactorial; there is a need to understand it even deeper. The new treatments and different delivery systems seem promising and provide a hope of effective treatment for DED. The thickness and shade of a restoration will affect the transmission of light from the light-curing unit (LCU). This study determined the power (mW), spectral radiant power (mW/nm), and beam profile of different LCUs through various thicknesses and shades of a CAD-CAM resin composite (BRAVA Block, FGM). Five thicknesses: 0.5; 0.75; 1.0; 1.5, and 2.0 mm, in three shades: Bleach; A2 and A3.5 of a CAD-CAM resin (n = 5). Two single-peak LCUs: EL, Elipar DeepCure-S (3M Oral Care); and OP, Optilight Max (Gnatus), and one multiple-peak LCU: VL, VALO Grand (Ultradent), were used. The LCUs were positioned touching the surface of the BRAVA Block. The power and emission spectrum were measured using a fiberoptic spectrometer attached to an integrating sphere, and the beam profiles using a laser beam profiler. The effect of the material thickness on the light attenuation coefficients was determined. VL and EL delivered more homogeneous beam profiles than OP. The type of the BRAVA Block had a significant effect on the transmitted power, and wavelengths of transmitted light (p < 0.001). There was an exponential reduction in the power and emission spectrum as the thickness of the BRAVA Block increased (p < 0.001). The light transmission through the A2 shade was least affected by the thickness (p < 0.001). The attenuation coefficient was higher for the violet light and higher for A3.5 than the A2 or Bleach shades. No violet light from the VL could be detected at the bottom of 2.0 mm of the BRAVA Block. To analyze the effect of using the resin-based composite manufacturer's recommended exposure time on the degree of conversion (DC), Knoop hardness (KH), and elastic modulus (E) of conventional and bulk-fill resin-based composites (RBCs). Three resin-based composites (RBCs) were tested: Tetric EvoCeram Bulk Fill (TET), Opus Bulk Fill APS (OPU), and RBC Vittra APS (VIT). They were photo-activated in 2 mm deep, 6 mm diameter molds for their recommended exposure times of 10 seconds, 20 seconds, or 40 seconds from four light-curing units (LCUs). Two delivered a single emission peak in the blue light region (Optilight Max and Radii-Cal) and two delivered multiple emission peaks in the violet and blue region (VALO Cordless and Bluephase G2). After 24 hours of dry storage at 37°C in the dark, the KH (Kgf/mm2), E (MPa) and DC (%) at the top and bottom surfaces of specimens (n=5) were measured and the results analyzed by 2-way analysis of variance (ANOVA) followed by a Tukey test (α=0.05). The irradiance (mW/cm2) and spectral irradiance (mW/cm2/nm) from the LCUs were reduced significantly (8-35%) after passing through 2.0 mm of RBC (p<0.001). The DC at the bottom of VIT and TET was less than at the top surface (p<0.001). OPU had the same DC at the top and bottom surface (p=0.341). The KH and E values at the top surface of VIT and TET were substantially higher than at the bottom (p<0.001). OPU exposed for 40 seconds achieved higher mechanical properties than TET that was photo-activated for 10 seconds (p<0.001). The opacity of different bulk-fill RBCs changed differently during the polymerization; OPU became more opaque, whereas TET became more transparent. When exposed for their recommended times, the 2 mm thick RBCs that used Ivocerin or the APS photoinitiator system were adequately photo-activated using either the single or multiple emission peak LCUs (p=0.341). After 24 hours' storage, all the 2 mm thick RBCs photo-cured in 6 mm diameter molds achieved a bottom-to-top hardness ratio of at least 80% when their recommended exposure times were used. TET, when photo-activated for 10 seconds, achieved lower mechanical properties than OPU that had been photo-activated for 40 seconds. The change in opacity of the RBCs was different during photo-activation.
DOI: 10.58347/tml.2024.1694c 논문 보기
RF BYRYZN Open Access
The efficacy of intradermal hyaluronic acid filler as a skin quality booster: A prospective, single-center, single-arm pilot study.
Lee JH, Kim J, Lee YN et al. ·Journal of cosmetic dermatology ·2024
초록 펼치기
The use of "skin boosters" comprised of hyaluronic acid (HA)-based fillers to improve skin quality has gained popularity recently, especially in individuals interested in skin rejuvenation. This study aimed to evaluate the efficacy and safety of intradermal micropuncture injections of HA-based gel filler combined with lidocaine (BYRYZN® SKINBOOSTER HA, ACROSS Co., Ltd., Gangwon-do, Korea). A prospective, single-arm, open-label pilot study was conducted with study subjects who were aged between 30 and 60 years old and exhibited evidence of skin aging, such as wrinkles and loss of elasticity. They received three injections at 2-week intervals and were followed up for a total of 12 weeks. Twenty subjects with a mean age of 54.1 years were included. The mean Lemperle wrinkle scale demonstrated a 40% decrease from 2.60 ± 0.60 at baseline to 1.55 ± 0.51 at week 8. The improvement rate was maintained at about 33% until week 12. The average maximum height of the wrinkle (Rz, μm), average skin roughness (Ra, μm), skin elasticity (R2, AU), facial curved length (mm), skin pore size (mm2 ), skin hydration (AU), TEWL (g/hm2 ), and skin glossiness (gloss value, AU) exhibited statistically significant improvements over time compared with the baseline measurements. No serious adverse effects or persistent adverse effects were reported, except for a transient subcutaneous nodule in one subject. This study demonstrates that multiple microinjections of HA-based gel filler for facial skin aging are safe and effective in improving facial skin quality.
DOI: 10.1111/jocd.15944 논문 보기
RF EXILIS Open Access
Massive branchial henneguyosis of catfish: A distinct, myxozoan-induced gill disease caused by severe interlamellar Henneguya exilis infection in catfish aquaculture.
Stilwell JM, Griffin MJ, Leary JH et al. ·Veterinary pathology ·2024
초록 펼치기
Henneguya sp. is a crucial myxosporean parasite known to cause milky flesh or tapioca disease in the freshwater fish population, leading to heavy mortality. Studies to investigate its host range and to monitor their prevalence in wild and aquacultured fish are necessary. The infected orange-spotted snakehead (Channa aurantimaculata) fish samples showing clinical signs such as severe ulceration and open wounds on the mouth and operculum were collected from an ornamental fish-rearing unit in Chennai, Tamil Nadu. The sample was diagnosed with myxosporean infection by microscopic observation, morphological records and DNA sequencing followed by phylogenetic analysis. The Henneguya infection was identified in C. aurantimaculata for the first time. Necropsy of the infected fish revealed characteristic multifocal whitish-yellow, oval-shaped cysts measuring 3-5 mm in length on the liver and spleen. The wet mount of cysts showed numerous mature Henneguya spores that were uninucleate, elongated, lenticular and ellipsoidal with the bluntly rounded anterior end gradually tapering off to the posterior with a caudal elongation. The spore body measured 12.1 ± 0.9 μm (10.1-14.7 μm) × 7.1 ± 0.6 μm (5.3-8.5 μm) with two slightly unequal pyriform polar capsules of 6.1 ± 0.5 μm (5.1-7.4 )× 2.5 ± 0.4 μm (1.6-3.9) (large); 6.0 ± 0.4 μm (5.2-6.4) × 2.5 ± 0.3 μm (1.7-3.1) (small) and a caudal elongation of 16.1 ± 1.2 μm in length. The parasite was confirmed to be a Henneguya sp. by PCR amplification of SSrRNA followed by gene sequencing. The sequence generated was submitted in the GenBank under accession number PP852214.1 The maximum likelihood analysis revealed that the obtained sequence is a close relative of H. exilis with pairwise sequence variation of 3.3% and a homology of 99.04%. The findings highlight the potential impact of Henneguya sp. on ornamental fish health, underscoring the need for vigilant monitoring and management in India. Proliferative gill disease (PGD), caused by the myxozoan Henneguya ictaluri, has been the most notorious parasitic gill disease in the US catfish aquaculture industry. In 2019, an unusual gill disease caused by massive burdens of another myxozoan, Henneguya exilis, was described in channel (Ictalurus punctatus) × blue (Ictalurus furcatus) hybrid catfish. Targeted metagenomic sequencing and in situ hybridization (ISH) were used to differentiate these conditions by comparing myxozoan communities involved in lesion development and disease pathogenesis between massive H. exilis infections and PGD cases. Thirty ethanol-fixed gill holobranchs from 7 cases of massive H. exilis infection in hybrid catfish were subjected to targeted amplicon sequencing of the 18S rRNA gene and compared to a targeted metagenomic data set previously generated from clinical PGD case submissions. Furthermore, serial sections of 14 formalin-fixed gill holobranchs (2 per case) were analyzed by RNAscope duplex chromogenic ISH assays targeting 8 different myxozoan species. Targeted metagenomic and ISH data were concordant, indicating myxozoan community compositions significantly differ between PGD and massive branchial henneguyosis. Although PGD cases often consist of mixed species infections, massive branchial henneguyosis consisted of nearly pure H. exilis infections. Still, H. ictaluri was identified by ISH in association with infrequent PGD lesions, suggesting coinfections occur, and some cases of massive branchial henneguyosis may contain concurrent PGD lesions contributing to morbidity. These findings establish a case definition for a putative emerging, myxozoan-induced gill disease of farm-raised catfish with a proposed condition name of massive branchial henneguyosis of catfish (MBHC). Proliferative gill disease (PGD) in Channel Catfish Ictalurus punctatus and hybrid catfish (Channel Catfish × Blue Catfish I. furcatus) is attributed to the myxozoan Henneguya ictaluri. Despite evidence of decreased H. ictaluri transmission and impaired parasite development in hybrid catfish, PGD still occurs in hybrid production systems. Previous metagenomic assessments of clinical PGD cases revealed numerous myxozoans within affected gill tissues in addition to H. ictaluri. The objective of this study was to investigate the development and pathologic contributions of H. ictaluri and other myxozoans in naturally and experimentally induced PGD. Henneguya species-specific in situ hybridization (ISH) assays were developed using RNAscope technology. Natural infections were sourced from diagnostic case submissions in 2019. Experimental challenges involved Channel Catfish and hybrid catfish exposed to pond water from an active PGD outbreak, and the fish were sampled at 1, 7, 10, 12, 14, 16, 18, and 20 weeks postchallenge. Nine unique ISH probes were designed, targeting a diagnostic variable region of the 18S ribosomal RNA gene of select myxozoan taxa identified in clinical PGD cases. Partial validation from pure H. ictaluri, H. adiposa, H. postexilis, and H. exilis infections illustrated species-specific labeling and no cross-reactivity between different myxozoan species or the catfish hosts. After experimental challenge, mature plasmodia of H. ictaluri and H. postexilis formed in Channel Catfish but were not observed in hybrids, suggesting impaired or delayed sporogenesis in the hybridized host. These investigations also confirmed the presence of mixed infections in clinical PGD cases. Although H. ictaluri appears to be the primary cause of PGD, presporogonic stages of other myxozoans were also present, which may contribute to disease pathology and exacerbate respiratory compromise by further altering normal gill morphology. This work provides molecular confirmation and more resolute developmental timelines of H. ictaluri and H. postexilis in Channel Catfish and supports previous research indicating impaired or precluded H. ictaluri sporogony in hybrid catfish. Novel species of fungi described in this study include those from various countries as follows: Antartica, Cladosporium austrolitorale from coastal sea sand. Australia, Austroboletus yourkae on soil, Crepidotus innuopurpureus on dead wood, Curvularia stenotaphri from roots and leaves of Stenotaphrum secundatum and Thecaphora stajsicii from capsules of Oxalis radicosa. Belgium, Paraxerochrysium coryli (incl. Paraxerochrysium gen. nov.) from Corylus avellana. Brazil, Calvatia nordestina on soil, Didymella tabebuiicola from leaf spots on Tabebuia aurea, Fusarium subflagellisporum from hypertrophied floral and vegetative branches of Mangifera indica and Microdochium maculosum from living leaves of Digitaria insularis. Canada, Cuphophyllus bondii from a grassland. Croatia, Mollisia inferiseptata from a rotten Laurus nobilis trunk. Cyprus, Amanita exilis on calcareous soil. Czech Republic, Cytospora hippophaicola from wood of symptomatic Vaccinium corymbosum. Denmark, Lasiosphaeria deviata on pieces of wood and herbaceous debris. Dominican Republic, Calocybella goethei among grass on a lawn. France (Corsica), Inocybe corsica on wet ground. France (French Guiana), Trechispora patawaensis on decayed branch of unknown angiosperm tree and Trechispora subregularis on decayed log of unknown angiosperm tree. Germany, Paramicrothecium sambuci (incl. Paramicrothecium gen. nov.) on dead stems of Sambucus nigra. India, Aureobasidium microtermitis from the gut of a Microtermes sp. termite, Laccaria diospyricola on soil and Phylloporia tamilnadensis on branches of Catunaregam spinosa. Iran, Pythium serotinoosporum from soil under Prunus dulcis. Italy, Pluteus brunneovenosus on twigs of broadleaved trees on the ground. Japan, Heterophoma rehmanniae on leaves of Rehmannia glutinosa
DOI: 10.1177/03009858241259181 논문 보기
RF POLLOGEN Open Access
Case Series: Therapeutic Combination of VoluDerm Radiofrequency Microneedling and Glycolic Acid Peel in Scaled-Up Concentrations.
Levenberg A, Vinshtok Y, Gershonowitz A ·Aesthetic surgery journal. Open forum ·2024
초록 펼치기
Glycolic acid (GA) is an α-hydroxy peeling agent that causes controlled removal of the epidermis, with or without the dermis. Studies have shown the ability of GA to stimulate fibroblast proliferation, induce collagen synthesis, and decrease collagen degradation. The VoluDerm radiofrequency microneedling (RFMN; Pollogen, Tel Aviv, Israel) utilizes an array of microelectrodes to penetrate the epidermis and deliver energy to the skin. The controlled fractional thermal injury promotes neocollagenesis in the correction of skin laxity and wrinkle reduction. It was theorized that GA and VoluDerm could synergistically boost collagen production in combined treatment. Safety and efficacy of the combination treatment were investigated in patients seeking corrections of the age-related skin deteriorations. Seven female patients (aged 42-70 years, Fitzpatrick II-IV) with photo- and chrono-damaged skin received 5 treatments of VoluDerm followed by the GA peel at increasing 30% to 70% concentrations. Clinical photography taken 6 months after the treatment demonstrated improvement in elasticity, wrinkling, roughness, pigmentation, erythema, and pore size across the entire treated group. Efficacy quantified by the physician and patients per 1 to 5 Global Aesthetic Improvement Scale was average 4.3 and 4.5, respectively. The treatments were tolerated well without preprocedural anesthesia. Skin phenomena observed after GA application were suggestive of the acid passing to deeper layers. A novel combination of VoluDerm RFMN and GA at increased concentrations provided safe and effective synergy in the treatment of aging facial skin. Visible results demonstrated skin tightening, reduction of rhytidids, and improvement of the skin texture which may be a result of the combination. Background: Oxygenation of the skin has been shown to improve cell growth and cell biosynthesis, which can subsequently improve the skin's appearance.1,2 However, the majority of skin oxygenation techniques are invasive.3,4 A noninvasive skin oxygenation treatment, also known as a carboxytherapy facial, with TriPollar® radiofrequency device has emerged called OxyGeneo™, which is provided by the geneO+™ skin care platform (Pollogen Ltd., Tel Aviv, Israel). Objective: This study addresses the clinical effectiveness of the aforementioned noninvasive skin oxygenation treatment on skin texture, fine lines/wrinkles, and skin pigmentation over an eight-week time period. Methods and materials: Ten patients with fine lines, wrinkles, hyperpigmentation, and rough skin texture received six weekly treatments over a two-month period. Five patients received NeoRevive™ and five received NeoBright™ topical infusions, with the selection made according to each individual's skin conditions and type. These patients were evaluated using the VISIA complexion analysis system (Canfield Scientific, Inc., Parsippany, New Jersey) and patient and evaluator assessments and satisfaction surveys. Results: Each individual measurement varied by patient, but the change in value of each category that was assessed prior to treatment and post-treatment indicated an improvement. All patients in the study stated an improvement in overall skin appearance, skin texture, brightness, and shininess. Nine out of the 10 patients reported that their skin was softer and had a more youthful appearance after the treatments, and seven out of the 10 patients saw a minor improvement in fine lines and wrinkles. Lastly, five out of the 10 patients noticed an improvement in skin pigmentation. Conclusion: The results indicated the combination of the three-in-one OxyGeneo treatment of exfoliation, infusion and oxygenation using TriPolar radiofrequency prompted an improvement in skin texture and tone. This is an optimal procedure that can be implemented in patients looking for noninvasive, safe, and effective rejuvenation treatments with no associated downtime post-procedure.
DOI: 10.1093/asjof/ojae075 논문 보기
RF PENTO Open Access
Are prophylactic antibiotics effective in preventing osteoradionecrosis after high-risk dental extractions?
Majid OW ·Evidence-based dentistry ·2024
초록 펼치기
Medication-related osteonecrosis of the jaw (MRONJ) is a severe adverse effect associated with antiresorptive and antiangiogenic treatments commonly prescribed for patients with cancer or osteoporosis. The increasing prescription of these drugs, coupled with the introduction of new anti-cancer medications, has raised concerns regarding the increasing risk of MRONJ. While the precise mechanisms underlying MRONJ remain unclear and effective therapies are still lacking, two repurposed pharmacological protocols-teriparatide (TPTD) and the combination of pentoxifylline (PTX) and α-tocopherol (TOC) [PENTO protocol]-have demonstrated potential therapeutic benefits. However, large-scale clinical evidence remains insufficient. This review evaluates the therapeutic potential of these targeted drug repurposing protocols, exploring their mechanisms of action in MRONJ management and proposing a clinical application protocol for both prevention and treatment. This study also highlights the potential of drug repurposing as a rapid and cost-effective approach for MRONJ management, particularly for patients with cancer, and emphasises the need for further research on personalised and localised management strategies. Nevertheless, the current evidence base is limited by small sample sizes, heterogeneous patient populations, non-randomised study designs, and inconsistent outcome measures, precluding definitive conclusions regarding efficacy and optimal clinical use. To assess the proportion of adverse effects (AEs) associated with the use of PENTO or PENTOCLO protocols for the prevention and management of osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ). A systematic literature search was conducted across six databases (PubMed, Scopus, Embase, Web of Science, LILACS, and Cochrane Library) and gray literature, with no restrictions on date or language. Studies were eligible if they involved adults (≥ 18 years) with or at risk for ORN or MRONJ and reported AEs associated with PENTO or PENTOCLO for prevention or treatment. A proportion meta-analysis estimated the overall frequency of AEs. Subgroup analyses compared AE rates between prevention and treatment contexts and between the two regimens. Of 1,075 records screened, 9 studies met the inclusion criteria. No studies reported AEs in MRONJ patients; all focused on ORN. The pooled AE proportion was 15% (95% CI: 3.6%-11.5%; p < 0.1; I2 = 55.8%). Gastrointestinal symptoms were the most reported AEs (46.38%), followed by neurovegetative effects (18.84%). AEs were more frequent in treatment settings and more prevalent in patients using PENTOCLO (28%). The PENTO(CLO) protocols were associated with a 15% overall AE rate, predominantly gastrointestinal symptoms. AEs occurred more often during treatment and with the PENTOCLO regimen. These findings highlight the need for close monitoring and further studies to assess safety in MRONJ patients. Medication-related osteonecrosis of the jaws (MRONJ) is a complex oral condition for which no global consensus on management currently exists, underscoring the need to establish internationally accepted therapeutic protocols. The use of platelet-rich fibrin (PRF) and the adjunctive administration of pentoxifylline and tocopherol (PenTo) have shown promising preliminary results in the clinical management of MRONJ; however, robust data remain limited. The aim of this study is to analyze the outcomes of surgically treated patients with stage I and II MRONJ, incorporating PenTo as an adjuvant to platelet concentrate therapy. Furthermore, the study seeks to evaluate both clinical and radiographic outcome variables throughout the follow-up period. A controlled pharmacological clinical trial was conducted, using a standard drug regimen as the comparator. Total 20 patients diagnosed with stage I or II MRONJ were allocated into 2 groups: one group received surgical treatment combined with PRF, while the other underwent the same protocol supplemented with an adjuvant therapeutic regimen based on PenTo. Participants were recruited from the Oral Medicine Department, School of Dentistry, Universidad Católica de Córdoba. Statistically significant differences were observed in the mean duration of antiresorptive therapy, which was notably longer in patients with osteoporosis (P = .01). Zoledronic acid was the most frequently associated drug (P = .0019). The addition of PenTo to the treatment protocol was associated with improved clinical and radiographic outcomes, with statistically significant differences (P = .0138 and P = .0046, respectively). Furthermore, the diagnostic stage (I or II) showed a significant correlation with clinical improvement following treatment (P = .0294). The healing index at 15, 90, and 180 days was higher in the group receiving PenTo, with statistically significant differences at each time point (P = .0441; P = .0001; P = .0018, respectively). In oncological patients, the healing index was also higher at all follow-up stages, with clear statistical significance (P = .0294; P = .0004; P = .0042). This study contributes with patient-based evidence to support the interdisciplinary management of MRONJ. The combination of surgical treatment, PRF, and PenTo may serve to optimize and enhance clinical strategies for this condition. Osteoradionecrosis (ORN) is a severe complication of external beam radiation therapy or brachytherapy in patients with head and neck cancer. Traditional theories of its etiology have been unsuccessful in producing a standardized treatment protocol. The theory of radiation-induced fibrosis (RIF) proposes that radiation is responsible for the formation of reactive oxygen species, cytokine production, and constitutive phenotypic expression of myofibroblasts contributing to the development of ORN. The support of the RIF theory in the development of ORN is the basis for the pentoxifylline and tocopherol (PENTO) protocol for the prevention and management of ORN. The authors searched for studies published through April 6, 2025, in the following electronic databases: PubMed, Scopus, Cochrane Library, and ScienceDirect. Peer-reviewed publications were included if they were written in the English language, studied the use of the PENTO protocol, and had "pentoxifylline," "osteoradionecrosis," and "jaw" in their title, abstract, or key words. Sixty-eight articles met the inclusion criteria, 60 of which were included in this scoping review. The authors aimed to describe the pathophysiology of RIF and determine whether the PENTO protocol is effective in the treatment and prevention of ORN of the jaws, thereby warranting further research. The results of this review suggest the PENTO protocol may provide a viable method of both prevention and management of ORN. However, further research is needed to determine the efficacy and safety of the PENTO protocol. The authors emphasized the need for a well-formulated, multidisciplinary, double-blinded, prospective, randomized clinical trial to investigate the use of the PENTO protocol in the prevention and management of ORN of the jaws. Determining the most effective PENTO regimen will maximize patient healing and minimize morbidity. To evaluate the clinical use of pentoxifylline and tocopherol (PENTO), with or without clodronate (PENTOCLO), in the treatment and prevention of osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ). A literature review was conducted using PubMed from database inception to May 2025. Studies were included if they evaluated PENTO or PENTOCLO for the treatment or prevention of ORN or MRONJ. Only human studies with full-text availability were included. Data extracted included patient population, intervention details, duration, co-interventions, outcomes, and adverse events. Twenty-two studies met inclusion criteria, comprising randomized trials, prospective cohorts, and retrospective ca
DOI: 10.1038/s41432-024-01068-6 논문 보기
RF PENTO Open Access
[The PENTO protocol in medication-related osteonecrosis of the jaw: A single-center phase IIa trial].
Dumur A, Pages E, Brie J et al. ·Bulletin du cancer ·2024
초록 펼치기
Medication-related osteonecrosis of the jaw (MRONJ) is a severe adverse effect associated with antiresorptive and antiangiogenic treatments commonly prescribed for patients with cancer or osteoporosis. The increasing prescription of these drugs, coupled with the introduction of new anti-cancer medications, has raised concerns regarding the increasing risk of MRONJ. While the precise mechanisms underlying MRONJ remain unclear and effective therapies are still lacking, two repurposed pharmacological protocols-teriparatide (TPTD) and the combination of pentoxifylline (PTX) and α-tocopherol (TOC) [PENTO protocol]-have demonstrated potential therapeutic benefits. However, large-scale clinical evidence remains insufficient. This review evaluates the therapeutic potential of these targeted drug repurposing protocols, exploring their mechanisms of action in MRONJ management and proposing a clinical application protocol for both prevention and treatment. This study also highlights the potential of drug repurposing as a rapid and cost-effective approach for MRONJ management, particularly for patients with cancer, and emphasises the need for further research on personalised and localised management strategies. Nevertheless, the current evidence base is limited by small sample sizes, heterogeneous patient populations, non-randomised study designs, and inconsistent outcome measures, precluding definitive conclusions regarding efficacy and optimal clinical use. To assess the proportion of adverse effects (AEs) associated with the use of PENTO or PENTOCLO protocols for the prevention and management of osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ). A systematic literature search was conducted across six databases (PubMed, Scopus, Embase, Web of Science, LILACS, and Cochrane Library) and gray literature, with no restrictions on date or language. Studies were eligible if they involved adults (≥ 18 years) with or at risk for ORN or MRONJ and reported AEs associated with PENTO or PENTOCLO for prevention or treatment. A proportion meta-analysis estimated the overall frequency of AEs. Subgroup analyses compared AE rates between prevention and treatment contexts and between the two regimens. Of 1,075 records screened, 9 studies met the inclusion criteria. No studies reported AEs in MRONJ patients; all focused on ORN. The pooled AE proportion was 15% (95% CI: 3.6%-11.5%; p < 0.1; I2 = 55.8%). Gastrointestinal symptoms were the most reported AEs (46.38%), followed by neurovegetative effects (18.84%). AEs were more frequent in treatment settings and more prevalent in patients using PENTOCLO (28%). The PENTO(CLO) protocols were associated with a 15% overall AE rate, predominantly gastrointestinal symptoms. AEs occurred more often during treatment and with the PENTOCLO regimen. These findings highlight the need for close monitoring and further studies to assess safety in MRONJ patients. Medication-related osteonecrosis of the jaws (MRONJ) is a complex oral condition for which no global consensus on management currently exists, underscoring the need to establish internationally accepted therapeutic protocols. The use of platelet-rich fibrin (PRF) and the adjunctive administration of pentoxifylline and tocopherol (PenTo) have shown promising preliminary results in the clinical management of MRONJ; however, robust data remain limited. The aim of this study is to analyze the outcomes of surgically treated patients with stage I and II MRONJ, incorporating PenTo as an adjuvant to platelet concentrate therapy. Furthermore, the study seeks to evaluate both clinical and radiographic outcome variables throughout the follow-up period. A controlled pharmacological clinical trial was conducted, using a standard drug regimen as the comparator. Total 20 patients diagnosed with stage I or II MRONJ were allocated into 2 groups: one group received surgical treatment combined with PRF, while the other underwent the same protocol supplemented with an adjuvant therapeutic regimen based on PenTo. Participants were recruited from the Oral Medicine Department, School of Dentistry, Universidad Católica de Córdoba. Statistically significant differences were observed in the mean duration of antiresorptive therapy, which was notably longer in patients with osteoporosis (P = .01). Zoledronic acid was the most frequently associated drug (P = .0019). The addition of PenTo to the treatment protocol was associated with improved clinical and radiographic outcomes, with statistically significant differences (P = .0138 and P = .0046, respectively). Furthermore, the diagnostic stage (I or II) showed a significant correlation with clinical improvement following treatment (P = .0294). The healing index at 15, 90, and 180 days was higher in the group receiving PenTo, with statistically significant differences at each time point (P = .0441; P = .0001; P = .0018, respectively). In oncological patients, the healing index was also higher at all follow-up stages, with clear statistical significance (P = .0294; P = .0004; P = .0042). This study contributes with patient-based evidence to support the interdisciplinary management of MRONJ. The combination of surgical treatment, PRF, and PenTo may serve to optimize and enhance clinical strategies for this condition. Osteoradionecrosis (ORN) is a severe complication of external beam radiation therapy or brachytherapy in patients with head and neck cancer. Traditional theories of its etiology have been unsuccessful in producing a standardized treatment protocol. The theory of radiation-induced fibrosis (RIF) proposes that radiation is responsible for the formation of reactive oxygen species, cytokine production, and constitutive phenotypic expression of myofibroblasts contributing to the development of ORN. The support of the RIF theory in the development of ORN is the basis for the pentoxifylline and tocopherol (PENTO) protocol for the prevention and management of ORN. The authors searched for studies published through April 6, 2025, in the following electronic databases: PubMed, Scopus, Cochrane Library, and ScienceDirect. Peer-reviewed publications were included if they were written in the English language, studied the use of the PENTO protocol, and had "pentoxifylline," "osteoradionecrosis," and "jaw" in their title, abstract, or key words. Sixty-eight articles met the inclusion criteria, 60 of which were included in this scoping review. The authors aimed to describe the pathophysiology of RIF and determine whether the PENTO protocol is effective in the treatment and prevention of ORN of the jaws, thereby warranting further research. The results of this review suggest the PENTO protocol may provide a viable method of both prevention and management of ORN. However, further research is needed to determine the efficacy and safety of the PENTO protocol. The authors emphasized the need for a well-formulated, multidisciplinary, double-blinded, prospective, randomized clinical trial to investigate the use of the PENTO protocol in the prevention and management of ORN of the jaws. Determining the most effective PENTO regimen will maximize patient healing and minimize morbidity. To evaluate the clinical use of pentoxifylline and tocopherol (PENTO), with or without clodronate (PENTOCLO), in the treatment and prevention of osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ). A literature review was conducted using PubMed from database inception to May 2025. Studies were included if they evaluated PENTO or PENTOCLO for the treatment or prevention of ORN or MRONJ. Only human studies with full-text availability were included. Data extracted included patient population, intervention details, duration, co-interventions, outcomes, and adverse events. Twenty-two studies met inclusion criteria, comprising randomized trials, prospective cohorts, and retrospective ca
DOI: 10.1016/j.bulcan.2024.02.015 논문 보기
Ablative radiofrequency microplasma for lateral dermatochalasis-indications and treatment recommendations.
Nemet AY, Solomon-Cohen E, Aronovich A et al. ·Lasers in medical science ·2024
초록 펼치기
To investigate the efficacy of micro-plasma radio-frequency (MPRF) in enhancing the healing of infected skin ulcers. This study involved ten patients diagnosed with infected skin ulcers between May and December 2023. Treatments were administered using MPRF every three days until the ulcers healed completely. We assessed microbial infection status, wound healing progression, healing duration, and changes in patient-reported symptoms such as pain and itching. We also monitored for adverse effects, including erythema and blisters, and evaluated scar formation post-healing. Cultures from the wounds of all ten patients became negative after 2-8 MPRF treatments. After 7-15 treatments, over 90% of the ulcers healed, indicating an effective therapeutic outcome. Patients reported no itching or discomfort during treatment, experiencing only transient, mild, and tolerable pain. No cases of erythema, edema, or other skin irritations were observed. Six-month follow-up showed mild scarring in the treated areas, primarily presenting as hyperpigmentation or hypopigmentation. Micro-plasma radio-frequency (MPRF) demonstrates significant potential in promoting the healing of infected skin ulcers. This is evidenced by the rapid bacterial clearance (cultures turning negative after 2-8 treatments) and a high healing rate (>90% after 7-15 treatments) observed in all 10 patients. Furthermore, its ease of operation, convenient application, and favorable safety profile-characterized by transient, mild, and tolerable pain, absence of local skin irritation (e.g., erythema, edema), and mild scar formation (primarily hyper- or hypopigmentation) upon 6-month follow-up-underscore its promise. While these preliminary findings are encouraging, further large-scale clinical studies are warranted to conclusively establish the efficacy and long-term safety of MPRF in wound healing. This study is classified as a case series, as it included only 10 patients and lacked a control group for comparison. Such a study design does not provide high-level evidence of causality; its findings primarily offer descriptive observations and preliminary evidence for future higher-quality research, such as randomized controlled trials. Skin cancer is the most frequently diagnosed form of cancer worldwide. Diagnostic uncertainty can arise when macroscopic or dermoscopic evaluations do not clearly differentiate between benign and malignant lesions. Laser-induced plasma spectroscopy (LIPS), traditionally used in fields like materials science and environmental analysis, has recently gained attention for its applications in human tissue assessment. LIPS works by generating a (micro)plasma when a laser interacts with tissue, producing element-specific light emissions that can be analyzed in real time. In this study, we explored the potential of LIPS to differentiate between benign and malignant skin lesions using the Spectra-Scope® Score (SSS). Our results revealed a clear distinction: benign lesions showed a median SSS of 1.7, while suspicious and malignant lesions had a significantly higher median score of 8.1 (p < 0.001). Receiver operating characteristic (ROC) curve analysis demonstrated strong diagnostic performance, with an area under the curve (AUC) of 0.82 (p < 0.001). The findings of this preliminary study support the high accuracy of LIPS in identifying malignancy and underscore its promise as a non-invasive, real-time diagnostic aid. Integrating SSS into clinical workflows could enhance the early detection of skin cancer and reduce reliance on invasive diagnostic procedures. However, further validation is needed to fully establish its role in routine dermatological practice. We developed a sensor called the Submerged Plasma for Isotopic Detection and Elemental Resolution (SPIDER) probe, which uses an atmospheric pressure glow discharge below the surface of liquids to excite species in the liquid. Through emission spectroscopy of molten salts, liquid metals, and heavy water, we demonstrated the SPIDER probe's high resolution, accuracy, and versatility. We successfully identified trace concentrations of transition and rare-earth metals in molten salts and detected the isotopic shift of the Hβ→ Dβ emission line. Our analysis revealed unconventional spectral alkali line shapes, indicating two competing excitation modes: film explosion and droplet vaporization. The film explosion mode, characterized by dense plasma, exhibited self-reversal and broadband continuum emission, while the droplet vaporization mode, associated with diffusive plasma, produced narrow-line emissions. By analyzing circuit transients alongside individual plasma events, we observed that film explosions generate higher currents, likely due to a shorter plasma length as the current preferentially flows through the thin liquid layer. Altogether, our results highlight the SPIDER probe's efficacy and flexibility, making it well-suited for online material quantification of liquids in extreme environments. Hydroxyapatite (HA) has become a widely used material for bone grafting and surface modification of titanium-based orthopedic implants due to its excellent biocompatibility. Among various coating techniques, microplasma spraying (MPS) has gained significant industrial relevance. However, the clinical success of HA coatings also depends on their adhesion to the implant substrate. Achieving durable fixation and reliable biological integration of orthopedic implants remains a major challenge due to insufficient coating adhesion and limited osseointegration. This study addresses challenges in dental and orthopedic implantology by evaluating the microstructure, mechanical properties, and biological behavior of bilayer coatings composed of a zirconium (Zr) sublayer and an HA top layer, applied via MPS onto titanium alloy. Surface roughness, porosity, and adhesion were characterized, and pull-off and shear tests were used to assess mechanical performance. In vitro biocompatibility was tested using rat mesenchymal stem cells (MSCs) to model osteointegration. The results showed that the MPS-fabricated Zr-HA bilayer coatings achieved a pull-off strength of 28.0 ± 4.2 MPa and a shear strength of 32.3 ± 3.2 MPa, exceeding standard requirements. Biologically, the HA top layer promoted a 45% increase in MSC proliferation over three days compared to the uncoated titanium substrate. Antibacterial testing also revealed suppression of E. coli growth after 14 h. These findings support the potential of MPS-applied Zr-HA coatings to enhance both the mechanical integrity and biological performance of titanium-based orthopedic implants. To observe the clinical efficacy of microplasma radiofrequency in treating post-traumatic pigmentary deposition using VISIA quantitative analysis, an innovative approach not previously emphasized in microplasma radiofrequency studies. Twenty patients with post-traumatic pigmentary deposition, treated at Cangzhou Central Hospital between July 2022 and December 2022, were selected. Pigmented areas were divided into four regions (A: control; B, C, D: treated with increasing energy parameters). Adverse effects (erythema, edema, micro-crusts, pruritus) were monitored at 2, 4, and 6 weeks post-treatment using CTCAE v5.0 criteria. Pigmentary deposition scores and VISIA parameters (spots, ultraviolet spots, red areas, brown spots) were evaluated. At 2, 4, and 6 weeks, Groups B, C, D showed significant reductions in pigment scores and VISIA parameters vs Group A (P < 0.05), with Group D (highest energy) achieving maximal improvement. Transient mild-moderate erythema (60-100%), edema (40-80%), and micro-crusts (20-60%) occurred in treated groups, resolving spontaneously within 14 days; no severe adverse events were observed. Microplasma radiofrequency significantly improves post-traumatic pigmentary deposition, with energy-dependent efficacy. Despite transient side effects at higher
DOI: 10.1007/s10103-024-04061-8 논문 보기
Silver microplasma-engineered nanoassemblies on periodic nanostructures for SERS applications.
Wang ZF, Tsai KC, Chiang WH et al. ·Physical chemistry chemical physics : PCCP ·2024
초록 펼치기
To investigate the efficacy of micro-plasma radio-frequency (MPRF) in enhancing the healing of infected skin ulcers. This study involved ten patients diagnosed with infected skin ulcers between May and December 2023. Treatments were administered using MPRF every three days until the ulcers healed completely. We assessed microbial infection status, wound healing progression, healing duration, and changes in patient-reported symptoms such as pain and itching. We also monitored for adverse effects, including erythema and blisters, and evaluated scar formation post-healing. Cultures from the wounds of all ten patients became negative after 2-8 MPRF treatments. After 7-15 treatments, over 90% of the ulcers healed, indicating an effective therapeutic outcome. Patients reported no itching or discomfort during treatment, experiencing only transient, mild, and tolerable pain. No cases of erythema, edema, or other skin irritations were observed. Six-month follow-up showed mild scarring in the treated areas, primarily presenting as hyperpigmentation or hypopigmentation. Micro-plasma radio-frequency (MPRF) demonstrates significant potential in promoting the healing of infected skin ulcers. This is evidenced by the rapid bacterial clearance (cultures turning negative after 2-8 treatments) and a high healing rate (>90% after 7-15 treatments) observed in all 10 patients. Furthermore, its ease of operation, convenient application, and favorable safety profile-characterized by transient, mild, and tolerable pain, absence of local skin irritation (e.g., erythema, edema), and mild scar formation (primarily hyper- or hypopigmentation) upon 6-month follow-up-underscore its promise. While these preliminary findings are encouraging, further large-scale clinical studies are warranted to conclusively establish the efficacy and long-term safety of MPRF in wound healing. This study is classified as a case series, as it included only 10 patients and lacked a control group for comparison. Such a study design does not provide high-level evidence of causality; its findings primarily offer descriptive observations and preliminary evidence for future higher-quality research, such as randomized controlled trials. Skin cancer is the most frequently diagnosed form of cancer worldwide. Diagnostic uncertainty can arise when macroscopic or dermoscopic evaluations do not clearly differentiate between benign and malignant lesions. Laser-induced plasma spectroscopy (LIPS), traditionally used in fields like materials science and environmental analysis, has recently gained attention for its applications in human tissue assessment. LIPS works by generating a (micro)plasma when a laser interacts with tissue, producing element-specific light emissions that can be analyzed in real time. In this study, we explored the potential of LIPS to differentiate between benign and malignant skin lesions using the Spectra-Scope® Score (SSS). Our results revealed a clear distinction: benign lesions showed a median SSS of 1.7, while suspicious and malignant lesions had a significantly higher median score of 8.1 (p < 0.001). Receiver operating characteristic (ROC) curve analysis demonstrated strong diagnostic performance, with an area under the curve (AUC) of 0.82 (p < 0.001). The findings of this preliminary study support the high accuracy of LIPS in identifying malignancy and underscore its promise as a non-invasive, real-time diagnostic aid. Integrating SSS into clinical workflows could enhance the early detection of skin cancer and reduce reliance on invasive diagnostic procedures. However, further validation is needed to fully establish its role in routine dermatological practice. We developed a sensor called the Submerged Plasma for Isotopic Detection and Elemental Resolution (SPIDER) probe, which uses an atmospheric pressure glow discharge below the surface of liquids to excite species in the liquid. Through emission spectroscopy of molten salts, liquid metals, and heavy water, we demonstrated the SPIDER probe's high resolution, accuracy, and versatility. We successfully identified trace concentrations of transition and rare-earth metals in molten salts and detected the isotopic shift of the Hβ→ Dβ emission line. Our analysis revealed unconventional spectral alkali line shapes, indicating two competing excitation modes: film explosion and droplet vaporization. The film explosion mode, characterized by dense plasma, exhibited self-reversal and broadband continuum emission, while the droplet vaporization mode, associated with diffusive plasma, produced narrow-line emissions. By analyzing circuit transients alongside individual plasma events, we observed that film explosions generate higher currents, likely due to a shorter plasma length as the current preferentially flows through the thin liquid layer. Altogether, our results highlight the SPIDER probe's efficacy and flexibility, making it well-suited for online material quantification of liquids in extreme environments. Hydroxyapatite (HA) has become a widely used material for bone grafting and surface modification of titanium-based orthopedic implants due to its excellent biocompatibility. Among various coating techniques, microplasma spraying (MPS) has gained significant industrial relevance. However, the clinical success of HA coatings also depends on their adhesion to the implant substrate. Achieving durable fixation and reliable biological integration of orthopedic implants remains a major challenge due to insufficient coating adhesion and limited osseointegration. This study addresses challenges in dental and orthopedic implantology by evaluating the microstructure, mechanical properties, and biological behavior of bilayer coatings composed of a zirconium (Zr) sublayer and an HA top layer, applied via MPS onto titanium alloy. Surface roughness, porosity, and adhesion were characterized, and pull-off and shear tests were used to assess mechanical performance. In vitro biocompatibility was tested using rat mesenchymal stem cells (MSCs) to model osteointegration. The results showed that the MPS-fabricated Zr-HA bilayer coatings achieved a pull-off strength of 28.0 ± 4.2 MPa and a shear strength of 32.3 ± 3.2 MPa, exceeding standard requirements. Biologically, the HA top layer promoted a 45% increase in MSC proliferation over three days compared to the uncoated titanium substrate. Antibacterial testing also revealed suppression of E. coli growth after 14 h. These findings support the potential of MPS-applied Zr-HA coatings to enhance both the mechanical integrity and biological performance of titanium-based orthopedic implants. To observe the clinical efficacy of microplasma radiofrequency in treating post-traumatic pigmentary deposition using VISIA quantitative analysis, an innovative approach not previously emphasized in microplasma radiofrequency studies. Twenty patients with post-traumatic pigmentary deposition, treated at Cangzhou Central Hospital between July 2022 and December 2022, were selected. Pigmented areas were divided into four regions (A: control; B, C, D: treated with increasing energy parameters). Adverse effects (erythema, edema, micro-crusts, pruritus) were monitored at 2, 4, and 6 weeks post-treatment using CTCAE v5.0 criteria. Pigmentary deposition scores and VISIA parameters (spots, ultraviolet spots, red areas, brown spots) were evaluated. At 2, 4, and 6 weeks, Groups B, C, D showed significant reductions in pigment scores and VISIA parameters vs Group A (P < 0.05), with Group D (highest energy) achieving maximal improvement. Transient mild-moderate erythema (60-100%), edema (40-80%), and micro-crusts (20-60%) occurred in treated groups, resolving spontaneously within 14 days; no severe adverse events were observed. Microplasma radiofrequency significantly improves post-traumatic pigmentary deposition, with energy-dependent efficacy. Despite transient side effects at higher
DOI: 10.1039/d4cp02723j 논문 보기