임상 논문

Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are widely used for weight management and type 2 diabetes, but reports of reduced skin laxity and volume have raised aesthetic concerns. This study evaluates the first integrated skincare protocol designed for GLP-1 RA users. This 12-week, double-blind, randomized, split-face/split-neck study included 25 GLP-1 RA users (mean age 53.36 years) with mild-to-moderate skin aging, including male and female participants with Fitzpatrick skin types II to VI. All participants applied a topical regimen featuring Proxylane and wild fruit flavonoids (Flavo-Proxylane) to one side of the face/neck and a placebo to the other. After 4 weeks of topical monotherapy, participants received a single focused ultrasound treatment, followed by an additional 8 weeks of topical therapy. Outcomes included blinded image evaluation, 13 clinical grading parameters (via modified Griffiths scale), Global Aesthetic Improvement Scale scores, tolerability, and patient-reported satisfaction. All participants completed the study and lost an average of 3.7 lb. After 4 weeks of Flavo-Proxylane monotherapy, significant improvements were observed for facial skin laxity (- 16%; P < 0.001) and marionette lines (- 5%; P < 0.05), while no significant changes were observed with placebo. By week 12, the combined regimen achieved amplified improvements versus baseline, week 4, and placebo (all P < 0.001), with total reductions of 44% in skin laxity and 34% in marionette lines. Significant improvements were observed across all 13 clinical parameters. Overall improvement rating favored Flavo-Proxylane, with 94% reporting moderate-to-significant improvement versus 30% for placebo. Flavo-Proxylane treatment was well tolerated, with 84% reporting improved skin appearance and only three mild, self-resolving adverse events. This study demonstrates that an integrated regimen with Flavo-Proxylane products and ultrasound may improve aesthetic outcomes in a diverse range of participants undergoing GLP-1 RA treatment. Skin laxity, driven by collagen/elastin degradation and aging, is targeted by micro-focused ultrasound (MFU) through depth-specific thermal coagulation to induce collagen remodeling, yet parameter-dependent thermal kinetics and safety thresholds remain underexplored, limiting protocol optimization. To validate the dose-effect relationship of MFU using in vitro porcine skin tissues and evaluate its safety and efficacy for human facial skin tightening. Porcine skin tissues containing intact skin, fat, and muscle layers were treated with 8D-DL 3.0, 8D-DL 4.5, Vmax-DL 3.0, and Vmax-DL 4.5 handpieces. Subcutaneous temperatures at depths of 2.0 mm, 3.0 mm, 4.5 mm, and 6.0 mm were recorded under varying parameters (energy levels and exposure durations). Twenty patients undergoing single-session MFU facial treatment between June and August 2024 were enrolled. Skin tightening outcomes were assessed at 30- and 90-days post-treatment. For 8D-DL 3.0 and Vmax-DL 3.0 handpieces, peak temperatures occurred at 3.0 mm depth across all energy levels and exposure durations. For 8D-DL 4.5 and Vmax-DL 4.5 handpieces, peak temperatures localized at 4.5 mm. Focal depth temperatures increased significantly with higher energy levels and prolonged exposure. At 30- and 90-days post-treatment, upward displacement and volume reduction in bilateral cheek and jawline regions were observed. Mild procedural pain was reported, with no adverse events. MFU-induced thermal peaks align with preset focal depths, demonstrating parameter-dependent thermal accumulation. The procedure safely achieves clinically significant facial skin tightening. Transcranial focused ultrasound (tFUS) is an emerging noninvasive neuromodulation modality with the ability to target deep brain structures with high spatial precision. Despite its promise, rigorous evaluation of its efficacy is limited by the absence of reliable, fully double-blind sham methodologies. To develop and validate a pair of visually and mechanically indistinguishable acoustic coupling pads that enable true double-blind tFUS neuromodulation studies by providing either efficient ultrasound transmission or robust ultrasound blocking without altering participant or operator experience. Two coupling pads were engineered: a transmitting pad designed to allow <5% pressure amplitude loss relative to free-water propagation, and a non-transmitting pad designed to attenuate ultrasound by ≥40 dB. Both pads used a Dragon Skin 10 NV silicone base and were identical in size, appearance, flexibility, and handling. The non-transmitting pad incorporated an encapsulated air-based blocking layer using an open-cell polyethylene foam insert. Acoustic performance was evaluated in a water tank using a 650 kHz BrainSonix transducer and a calibrated needle hydrophone. Sound speed of the silicone material was measured using pulse-echo techniques. Twenty-three matched transmitting and non-transmitting pad pairs were fabricated and tested. Transmitting pads demonstrated a mean attenuation of -0.41 ± 0.53 dB, satisfying the design criterion of minimal acoustic loss. Non-transmitting pads demonstrated a mean attenuation of -48.61 ± 4.33 dB, exceeding the required -40 dB threshold for effective sham conditions. The Dragon Skin 10 NV substrate exhibited a sound speed of 964.72 m/s and produced <2 mm axial focal shift for standard pad thicknesses, with no measurable change in focal width. Both pad types were visually and tactually indistinguishable, could not be differentiated by experienced operators or participants, and maintained mechanical integrity after repeated cleaning. These acoustically engineered coupling pads provide a practical and validated solution for achieving true single- and double-blind conditions in tFUS neuromodulation studies. By preserving identical sensory and procedural experiences while enabling precise control over ultrasound transmission, this approach addresses a critical methodological gap in human ultrasound neuromodulation research.

Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are widely used for weight management and type 2 diabetes, but reports of reduced skin laxity and volume have raised aesthetic concerns. This study evaluates the first integrated skincare protocol designed for GLP-1 RA users. This 12-week, double-blind, randomized, split-face/split-neck study included 25 GLP-1 RA users (mean age 53.36 years) with mild-to-moderate skin aging, including male and female participants with Fitzpatrick skin types II to VI. All participants applied a topical regimen featuring Proxylane and wild fruit flavonoids (Flavo-Proxylane) to one side of the face/neck and a placebo to the other. After 4 weeks of topical monotherapy, participants received a single focused ultrasound treatment, followed by an additional 8 weeks of topical therapy. Outcomes included blinded image evaluation, 13 clinical grading parameters (via modified Griffiths scale), Global Aesthetic Improvement Scale scores, tolerability, and patient-reported satisfaction. All participants completed the study and lost an average of 3.7 lb. After 4 weeks of Flavo-Proxylane monotherapy, significant improvements were observed for facial skin laxity (- 16%; P < 0.001) and marionette lines (- 5%; P < 0.05), while no significant changes were observed with placebo. By week 12, the combined regimen achieved amplified improvements versus baseline, week 4, and placebo (all P < 0.001), with total reductions of 44% in skin laxity and 34% in marionette lines. Significant improvements were observed across all 13 clinical parameters. Overall improvement rating favored Flavo-Proxylane, with 94% reporting moderate-to-significant improvement versus 30% for placebo. Flavo-Proxylane treatment was well tolerated, with 84% reporting improved skin appearance and only three mild, self-resolving adverse events. This study demonstrates that an integrated regimen with Flavo-Proxylane products and ultrasound may improve aesthetic outcomes in a diverse range of participants undergoing GLP-1 RA treatment. Skin laxity, driven by collagen/elastin degradation and aging, is targeted by micro-focused ultrasound (MFU) through depth-specific thermal coagulation to induce collagen remodeling, yet parameter-dependent thermal kinetics and safety thresholds remain underexplored, limiting protocol optimization. To validate the dose-effect relationship of MFU using in vitro porcine skin tissues and evaluate its safety and efficacy for human facial skin tightening. Porcine skin tissues containing intact skin, fat, and muscle layers were treated with 8D-DL 3.0, 8D-DL 4.5, Vmax-DL 3.0, and Vmax-DL 4.5 handpieces. Subcutaneous temperatures at depths of 2.0 mm, 3.0 mm, 4.5 mm, and 6.0 mm were recorded under varying parameters (energy levels and exposure durations). Twenty patients undergoing single-session MFU facial treatment between June and August 2024 were enrolled. Skin tightening outcomes were assessed at 30- and 90-days post-treatment. For 8D-DL 3.0 and Vmax-DL 3.0 handpieces, peak temperatures occurred at 3.0 mm depth across all energy levels and exposure durations. For 8D-DL 4.5 and Vmax-DL 4.5 handpieces, peak temperatures localized at 4.5 mm. Focal depth temperatures increased significantly with higher energy levels and prolonged exposure. At 30- and 90-days post-treatment, upward displacement and volume reduction in bilateral cheek and jawline regions were observed. Mild procedural pain was reported, with no adverse events. MFU-induced thermal peaks align with preset focal depths, demonstrating parameter-dependent thermal accumulation. The procedure safely achieves clinically significant facial skin tightening. Transcranial focused ultrasound (tFUS) is an emerging noninvasive neuromodulation modality with the ability to target deep brain structures with high spatial precision. Despite its promise, rigorous evaluation of its efficacy is limited by the absence of reliable, fully double-blind sham methodologies. To develop and validate a pair of visually and mechanically indistinguishable acoustic coupling pads that enable true double-blind tFUS neuromodulation studies by providing either efficient ultrasound transmission or robust ultrasound blocking without altering participant or operator experience. Two coupling pads were engineered: a transmitting pad designed to allow <5% pressure amplitude loss relative to free-water propagation, and a non-transmitting pad designed to attenuate ultrasound by ≥40 dB. Both pads used a Dragon Skin 10 NV silicone base and were identical in size, appearance, flexibility, and handling. The non-transmitting pad incorporated an encapsulated air-based blocking layer using an open-cell polyethylene foam insert. Acoustic performance was evaluated in a water tank using a 650 kHz BrainSonix transducer and a calibrated needle hydrophone. Sound speed of the silicone material was measured using pulse-echo techniques. Twenty-three matched transmitting and non-transmitting pad pairs were fabricated and tested. Transmitting pads demonstrated a mean attenuation of -0.41 ± 0.53 dB, satisfying the design criterion of minimal acoustic loss. Non-transmitting pads demonstrated a mean attenuation of -48.61 ± 4.33 dB, exceeding the required -40 dB threshold for effective sham conditions. The Dragon Skin 10 NV substrate exhibited a sound speed of 964.72 m/s and produced <2 mm axial focal shift for standard pad thicknesses, with no measurable change in focal width. Both pad types were visually and tactually indistinguishable, could not be differentiated by experienced operators or participants, and maintained mechanical integrity after repeated cleaning. These acoustically engineered coupling pads provide a practical and validated solution for achieving true single- and double-blind conditions in tFUS neuromodulation studies. By preserving identical sensory and procedural experiences while enabling precise control over ultrasound transmission, this approach addresses a critical methodological gap in human ultrasound neuromodulation research.

Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are widely used for weight management and type 2 diabetes, but reports of reduced skin laxity and volume have raised aesthetic concerns. This study evaluates the first integrated skincare protocol designed for GLP-1 RA users. This 12-week, double-blind, randomized, split-face/split-neck study included 25 GLP-1 RA users (mean age 53.36 years) with mild-to-moderate skin aging, including male and female participants with Fitzpatrick skin types II to VI. All participants applied a topical regimen featuring Proxylane and wild fruit flavonoids (Flavo-Proxylane) to one side of the face/neck and a placebo to the other. After 4 weeks of topical monotherapy, participants received a single focused ultrasound treatment, followed by an additional 8 weeks of topical therapy. Outcomes included blinded image evaluation, 13 clinical grading parameters (via modified Griffiths scale), Global Aesthetic Improvement Scale scores, tolerability, and patient-reported satisfaction. All participants completed the study and lost an average of 3.7 lb. After 4 weeks of Flavo-Proxylane monotherapy, significant improvements were observed for facial skin laxity (- 16%; P < 0.001) and marionette lines (- 5%; P < 0.05), while no significant changes were observed with placebo. By week 12, the combined regimen achieved amplified improvements versus baseline, week 4, and placebo (all P < 0.001), with total reductions of 44% in skin laxity and 34% in marionette lines. Significant improvements were observed across all 13 clinical parameters. Overall improvement rating favored Flavo-Proxylane, with 94% reporting moderate-to-significant improvement versus 30% for placebo. Flavo-Proxylane treatment was well tolerated, with 84% reporting improved skin appearance and only three mild, self-resolving adverse events. This study demonstrates that an integrated regimen with Flavo-Proxylane products and ultrasound may improve aesthetic outcomes in a diverse range of participants undergoing GLP-1 RA treatment. Skin laxity, driven by collagen/elastin degradation and aging, is targeted by micro-focused ultrasound (MFU) through depth-specific thermal coagulation to induce collagen remodeling, yet parameter-dependent thermal kinetics and safety thresholds remain underexplored, limiting protocol optimization. To validate the dose-effect relationship of MFU using in vitro porcine skin tissues and evaluate its safety and efficacy for human facial skin tightening. Porcine skin tissues containing intact skin, fat, and muscle layers were treated with 8D-DL 3.0, 8D-DL 4.5, Vmax-DL 3.0, and Vmax-DL 4.5 handpieces. Subcutaneous temperatures at depths of 2.0 mm, 3.0 mm, 4.5 mm, and 6.0 mm were recorded under varying parameters (energy levels and exposure durations). Twenty patients undergoing single-session MFU facial treatment between June and August 2024 were enrolled. Skin tightening outcomes were assessed at 30- and 90-days post-treatment. For 8D-DL 3.0 and Vmax-DL 3.0 handpieces, peak temperatures occurred at 3.0 mm depth across all energy levels and exposure durations. For 8D-DL 4.5 and Vmax-DL 4.5 handpieces, peak temperatures localized at 4.5 mm. Focal depth temperatures increased significantly with higher energy levels and prolonged exposure. At 30- and 90-days post-treatment, upward displacement and volume reduction in bilateral cheek and jawline regions were observed. Mild procedural pain was reported, with no adverse events. MFU-induced thermal peaks align with preset focal depths, demonstrating parameter-dependent thermal accumulation. The procedure safely achieves clinically significant facial skin tightening. Transcranial focused ultrasound (tFUS) is an emerging noninvasive neuromodulation modality with the ability to target deep brain structures with high spatial precision. Despite its promise, rigorous evaluation of its efficacy is limited by the absence of reliable, fully double-blind sham methodologies. To develop and validate a pair of visually and mechanically indistinguishable acoustic coupling pads that enable true double-blind tFUS neuromodulation studies by providing either efficient ultrasound transmission or robust ultrasound blocking without altering participant or operator experience. Two coupling pads were engineered: a transmitting pad designed to allow <5% pressure amplitude loss relative to free-water propagation, and a non-transmitting pad designed to attenuate ultrasound by ≥40 dB. Both pads used a Dragon Skin 10 NV silicone base and were identical in size, appearance, flexibility, and handling. The non-transmitting pad incorporated an encapsulated air-based blocking layer using an open-cell polyethylene foam insert. Acoustic performance was evaluated in a water tank using a 650 kHz BrainSonix transducer and a calibrated needle hydrophone. Sound speed of the silicone material was measured using pulse-echo techniques. Twenty-three matched transmitting and non-transmitting pad pairs were fabricated and tested. Transmitting pads demonstrated a mean attenuation of -0.41 ± 0.53 dB, satisfying the design criterion of minimal acoustic loss. Non-transmitting pads demonstrated a mean attenuation of -48.61 ± 4.33 dB, exceeding the required -40 dB threshold for effective sham conditions. The Dragon Skin 10 NV substrate exhibited a sound speed of 964.72 m/s and produced <2 mm axial focal shift for standard pad thicknesses, with no measurable change in focal width. Both pad types were visually and tactually indistinguishable, could not be differentiated by experienced operators or participants, and maintained mechanical integrity after repeated cleaning. These acoustically engineered coupling pads provide a practical and validated solution for achieving true single- and double-blind conditions in tFUS neuromodulation studies. By preserving identical sensory and procedural experiences while enabling precise control over ultrasound transmission, this approach addresses a critical methodological gap in human ultrasound neuromodulation research.