Literature review of adverse events associated with cryolipolysis.
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A firming and toning cosmetic body lotion (FTB) was developed to target key pathways relevant to body skin health and rejuvenation that may complement the improvements observed after noninvasive body contouring (NIBC). A pilot study explored the efficacy and tolerability of FTB as an adjunct to cryolipolysis. An open-label, single-site, single-arm, 12-week study enrolled subjects aged 20 to 65 who had pre-elected to receive 1 or more cryolipolysis treatments (CoolSculpting® or CoolSculpting® Elite; Zeltiq Aesthetics, Inc.) on the inner thigh, back/bra fat, or submental areas. Immediately post-procedure, the investigator applied FTB to the treated area. Subjects then applied FTB topically twice daily for 12 weeks on the treated area. Skin texture and firmness were graded visually by the investigator using a 10-point scale, and subjects graded effectiveness, product attributes, and satisfaction with a questionnaire.  Results: Seventeen subjects (16 women, 1 man) enrolled. After 12 weeks of FTB application, significant improvements in skin firmness were observed in all treated areas, while skin texture showed improvements on the inner thigh and back/bra fat (all P≤0.009). With continued use following cryolipolysis, more than 70% of subjects agreed that FTB improved skin firmness, smoothness, and overall appearance. Subjects indicated that FTB was an effective adjunct to cryolipolysis. Throughout the study, 86% to 92% of subjects reported “fair,” “good,” or “excellent” satisfaction with FTB.  Conclusion: This pilot study suggests that FTB may complement skin improvements seen post-NIBC.J Drugs Dermatol. 2024;23(4): doi:10.36849/JDD.7917. Cryolipolysis, also known as fat freezing, is a nonsurgical technique specialized for localized fat reduction. Utilizing targeted cold exposure to adipose tissue, cryolipolysis devices induce cellular apoptosis in adipocytes while sparing surrounding tissues, resulting in the selective disruption of fat cells and subsequent removal of damaged cells by macrophages. A reduction of the fat layer produces a noninvasive cosmetic benefit that provides an accessible alternative to liposuction. Objective and subjective measurements have demonstrated significant reduction in fat volume and high patient satisfaction rates. Cryolipolysis has been proven to be safe with minimal adverse effects. However, further research is needed to fully understand the mechanism of cryolipolysis and its efficacy in different treatment areas. This paper aims to provide a comprehensive overview of cryolipolysis, including its mechanism of action, indications, contraindications, adverse effects, results and outcomes, safety profile, and areas requiring further research. Our primary phase of literature review consisted of a PubMed search looking for all published literature around cryolipolysis. We employed a review approach that examined over 30 papers with the key search terms of "cryolipolysis," "fat-freezing," "cosmetic dermatology," "body contouring," "adverse effects," "adipocyte apoptosis," "Coolsculpting®," "cold panniculitis," and "localized fat reduction." We then analyzed each paper, extracting relevant information to gain a multidimensional understanding of cryolipolysis to provide a comprehensive review. Cryolipolysis, with its ability to target and reduce localized adipose tissue, has emerged as a promising nonsurgical technique in the field of body contouring. It offers patients a valuable option for achieving their desired fat reduction without the need for a lengthy recovery period or major surgery. Cryolipolysis has shown to reduce the number of adipocytes in the treated area, a phenomenon that can be objectively quantified through various means, including fat caliper measurements, ultrasound assessments, and 3D imaging, or subjectively observed through patient satisfaction rates, clinical observations, and investigator assessments. In addition to its effectiveness in reducing localized adipose tissue, cryolipolysis also holds potential in the area of skin tightening. Preliminary studies suggest that cryolipolysis may have a positive impact on skin elasticity and tightening. Further investigation of this mechanism is needed to provide a better understanding of its potential in achieving optimal cosmetic outcomes for patients. By combining the benefits of fat reduction and skin tightening, cryolipolysis has the potential to offer a comprehensive nonsurgical solution for body contouring. Noninvasive body contouring is becoming more popular in the United States as an alternative to liposuction. The most popular of these methods, cryolipolysis, uses precisely controlled cooling to reduce focal adiposities. The number of cryolipolysis procedures performed annually has experienced rampant growth in United States markets, and the indications have likewise diversified. In light of this change, it is imperative to perform an updated review of available US safety and efficacy data on cryolipolysis. To examine the safety and efficacy of cryolipolysis treatments in the United States using data extracted from research performed exclusively at US-based sites. In order to identify relevant studies, a literature search was conducted on PubMed using the terms "CoolSculpting" OR "cryolipolysis" OR "lipocryolysis." Articles were manually reviewed to exclude literature reviews, research not performed on humans, studies on experimental combinations of techniques, and any studies not performed in the United States. The initial literature search returned 246 results. Following manual review, a total of 18 studies were selected for data extraction. Mean reduction in fat thickness by ultrasound was 2.0-5.1 mm or 19.6%-32.3%; mean reduction by body caliper was 2.3-7 mm or 14.9%-21.5%. Side effects were mild and transient. Four instances of PAH were documented in 3453 treatment cycles. Cryolipolysis is a safe, modestly effective method for reducing focal adiposity. Complications are rare and treatable. However, US-based studies are few in number and often of low power and/or quality. More high-quality research is needed for all aspects of cryolipolysis. Cryolipolysis is a noninvasive procedure for localized fat reduction and body contouring. This technique utilizes controlled cooling to induce adipocyte apoptosis without damage to overlying skin and other tissue. Although the procedure was once thought to be relatively harmless, recent studies have shed light on the risks of adverse effects (AEs). The aim of this article was to review AEs in cryolipolysis as published in clinical data. A comprehensive search was performed in PubMed, using relevant keywords such as "cryolipolysis," "CoolSculpting," "adverse effects," "complications," and "side effects" with no set data range. The search was limited to studies published in English. The selected studies encompassed a variety of study designs, including randomized controlled trials, prospective cohort studies, case series, case reports, and reviews. Since its FDA approval in 2010, our understanding of the potential risks and complications associated with cryolipolysis has grown significantly, and shown that the procedure may not be as harmless as once thought. Continued post-market surveillance of cryolipolysis devices combined with documenting of AE cases help providers better understand the true risks associated with this procedure. As "cryolipolysis" and "CoolSculpting" are often used interchangeably, further research is needed to understand if AEs such as paradoxical adipose hyperplasia (PAH) that occur both inside and outside the United States are CoolSculpting cases or linked to other devices. Additionally, further studies are needed to understand the pathophysiology of such sequelae as PAH, and to better recognize the risks and potential complications associated with cryolipolysis so that