Improvement in Cellulite Appearance After a Single Treatment Visit With Acoustic Subcision: Long-Term Findings From a Multicenter Clinical Trial.

BACKGROUND: Cellulite is an aesthetically displeasing rippling or dimpling of the skin, primarily on the buttocks/thighs. A recent study showed a novel acoustic subcision device produced significant short-term (12-week) improvement in the appearance of cellulite after a single rapid acoustic pulse (RAP) treatment. OBJECTIVE: To evaluate the long-term (>52-weeks) efficacy and safety of RAP treatment for improvement in the appearance of cellulite. MATERIALS AND METHODS: In this prospective, multicenter trial, female participants ( n = 42) with severe cellulite were treated with the acoustic subcision device in a single visit. At >52 weeks, blinded board-certified dermatologists assessed efficacy by correctly identifying post-treatment photographs and using a 6-point simplified Cellulite Severity Scale (CSS). Participant satisfaction was also collected. Safety was assessed throughout. RESULTS: The blinded panel correctly identified post-treatment photographs at a rate of 95.2%; 70.4% of participants had a >1-point reduction in the CSS score from baseline (mean reduction of 1.09). All participants (100%) reported improved cellulite appearance. Overall pain during treatment was rated as 2.4 and 0.3 post-treatment (pain scale 0-10). No device or treatment-related adverse events were reported at the >52-week follow-up. CONCLUSION: Rapid acoustic pulse treatment significantly improved the long-term appearance of cellulite and was well-tolerated.

Multicenter Pivotal Study Demonstrates Safety and Efficacy of a New Cellulite Procedure: Final Results at 12 Months.

BACKGROUND: Safety and efficacy endpoints for the single-arm, multicenter, open-label pivotal study, CONtrolled Focal Fibrous Band Release Method (CONFFIRM) [NCT04743635] assessing targeted verifiable subcision (TVS) for the treatment of cellulite were met at 3 months postprocedure and have been published. Final, 12-month data describing durability of treatment effect and safety are presented here for the first time. OBJECTIVES: The authors sought to evaluate safety and efficacy out to 12 months of initial treatment for a single TVS procedure performed employing the Avéli device (Revelle Aesthetics, Inc.; Mountain View, CA) to treat cellulite on the buttock and thigh areas of adult females. METHODS: Effectiveness was determined by 3 independent physicians employing the Cellulite Severity Scale and Global Aesthetic Improvement Scale to assess improvement of baseline photographs when compared with 3-, 6- and 12-month posttreatment photographs. Blinded participant-reported outcomes and safety evaluations were also performed at all postprocedure time points. RESULTS: Clinically significant improvement in primary endpoint Cellulite Severity Scale scores were sustained out to 1 year, improving by 1.50 (P < .0001) at 3 months, 1.54 points at 6 months, and 1.48 points at 12 months. Adverse events were mild and mostly resolved by the 12-month visit. CONCLUSIONS: A single TVS treatment has durable efficacy and safety in reducing cellulite on the buttocks and thighs of women with moderate to severe cellulite out to 12 months posttreatment.

Multicenter Pivotal Study Demonstrates Safety and Efficacy of a New Cellulite Procedure: 3-Month Results.

BACKGROUND: Cellulite is an aesthetic condition affecting the appearance of skin in certain body regions and is associated with body dissatisfaction, psychosocial stress, and decreased quality of life. Previous studies established the safety and feasibility of a novel, minimally invasive device to identify and release septa responsible for cellulite depressions: targeted verifiable subcision (TVS). OBJECTIVES: The objective of this single-arm, open-label, multicenter study was to evaluate the safety and efficacy of TVS for reducing the appearance of moderate to severe cellulite in adult women. METHODS: Adult women aged 21 to 55 years and a BMI < 30 kg/m2 with moderate or severe cellulite on the buttocks and/or thighs were eligible to enroll at 9 sites. Endpoint data included results from 4 of the postprocedural follow-up visits at 24 hours, 7 days, 30 days, and 90 days. The primary endpoints were a mean ≥1 point reduction in the Cellulite Severity Scale at 90 days and no related serious adverse events at 30 days. RESULTS: Seventy-four female participants with a mean BMI of 24.8 ±â€…2.7 and age of 41.4 ±â€…7.4 years received this single procedure. The mean improvement in Cellulite Severity Scale (N = 68) was 1.5 ±â€…0.9 (P < 0.0001). There were no device-related serious adverse events at 30 days. CONCLUSIONS: TVS for selectively identifying and verifiably releasing septa responsible for cellulite depressions is an effective and safe means to improve the appearance of moderate to severe cellulite in adult women.

Collagenase Clostridium Histolyticum-aaes for Treatment of Cellulite: A Pooled Analysis of Two Phase-3 Trials.

Background: Collagen-rich fibrous septae and subcutaneous adipose protrusions play a role in cellulite pathophysiology. Collagenase clostridium histolyticum-aaes (CCH-aaes) injection causes enzymatic release of septae to resolve cellulite depressions and create a skin smoothing effect. This analysis pooled data from two identically designed, phase-3, randomized, double-blind, placebo-controlled studies to examine the efficacy and safety of CCH-aaes. Methods: Adult women with moderate/severe cellulite (3-4 on Clinician Reported Photonumeric Cellulite Severity Scale and Patient Reported Photonumeric Cellulite Severity Scale) on the buttocks received up to three treatment sessions (Days 1, 22, and 43) of subcutaneous CCH-aaes 0.84 mg or placebo per treatment area. Composite and individual component response (≥2-level or ≥1-level improvement from baseline in Patient Reported Photonumeric Cellulite Severity Scale and/or Clinician Reported Photonumeric Cellulite Severity Scale) and additional patient-reported outcomes were determined at Day 71. Results: Analysis included 424 CCH-aaes-treated and 419 placebo-treated women. CCH-aaes-treated women were 5.9 times more likely than placebo-treated women to be ≥2-level composite responders at Day 71 (odds ratio [95% confidence interval], 5.9 [2.2-15.4]; P < 0.001). A significantly greater percentage of CCH-aaes-treated women versus placebo-treated women were ≥1-level composite responders at Day 71 (39.4% versus 14.6%; P < 0.001). Subgroup analyses indicated no apparent impact of Fitzpatrick skin type category and baseline cellulite severity (moderate/severe) on CCH-aaes efficacy. An inverse relationship between age and CCH-aaes response was observed in those with a body mass index less than 32 kg per m2. The most common adverse events with CCH-aaes were injection-site bruising and injection-site pain. Conclusion: CCH-aaes treatment significantly improved moderate-to-severe buttock cellulite appearance and was generally well tolerated.

Study of a New Controlled Focal Septa Release Cellulite Reduction Method.

BACKGROUND: Cellulite is the dimpled appearance of skin that commonly occurs on the buttocks and thighs of postpubertal women. Cellulite can be emotionally distressing, causing many individuals to seek medical attention. A previous first-in-human study established the safety and feasibility of a novel minimally invasive method for selectively identifying and manually releasing the specific septa responsible for causing cellulite depressions in a precise manner. OBJECTIVES: The objective of this open-label, multicenter study was to evaluate the safety, efficacy, and feasibility of this method for reducing the appearance of moderate and severe cellulite in adult women. METHODS: Female patients (n = 20) 21 to 55 years old with a BMI ≤ 35 kg/m2 with moderate or severe cellulite on the buttocks and/or thighs were enrolled at 4 clinics. Patients were evaluated on posttreatment Days 7, 30, 120, and 180. The primary endpoint was a mean ≥1-point reduction in the Cellulite Severity Scale at 180 days. RESULTS: Most patients (n = 18, 95%) achieved the primary endpoint. All patients (n = 19, 100%) were rated as much improved or very much improved in Cellulite Severity Scale scores. Adverse events and investigator findings were mild and transient, and none were unexpected. CONCLUSIONS: A novel method for selectively identifying and manually releasing the specific septa responsible for causing cellulite depressions in a precise manner is a safe and effective means for improving the appearance of moderate and severe cellulite in adult women with a wide variety of skin types.

Improvement in the appearance of cellulite and skin laxity resulting from a single treatment with acoustic subcision: Findings from a multicenter pivotal clinical trial.

INTRODUCTION AND OBJECTIVES: Surface depressions and skin laxity together play a role in the appearance of cellulite. Cellulite depressions can be improved through disruption of the subcutaneous fibrous structures. Some currently utilized approaches accomplish this through invasive techniques requiring local anesthesia and potential down time. Skin laxity can exacerbate the appearance of cellulite, however current invasive approaches do little to improve skin laxity. The objective of this study was to evaluate a noninvasive approach to improving both cellulite depressions and skin laxity through the use of rapid acoustic pulses (acoustic subcision). Safety, efficacy, tolerability, and participant satisfaction results were measured. METHODS: Women (n = 56) with moderate to severe cellulite were treated in a single acoustic subcision treatment session without anesthesia. Posttreatment adverse events (AEs) and tolerability were recorded. At 12-weeks cellulite outcomes were assessed using a 6-point simplified Cellulite Severity Scale (CSS), Global Aesthetic Improvement Scale (GAIS), and a participant satisfaction questionnaire. Additionally, laxity improvement was measured using a 4-point Laxity Score (LS) and GAIS. RESULTS: Improvement in cellulite appearance measured at 12-weeks showed that participants (n = 56) had a mean CSS reduction of 1.01 (a 29.5% reduction from baseline). The posttreatment photograph was correctly identified by blinded independent reviewers from randomized pairs of pre/posttreatment photographs for 96.4% of participants. Cellulite was graded as improved, much improved or very much improved using the GAIS at 90.9% of treated locations. Finally, 92.9% of participants reported positive satisfaction responses. Scoring for improvement in skin laxity appearance at 12-weeks showed a mean LS reduction of 0.57 (a 27.9% reduction from baseline). GAIS for laxity was graded as improved, much improved or very much improved in 67.3% of treated areas. No unexpected or serious AEs were noted at treatment or follow-up. Overall average pain score during treatment was 2.4 (0-10 pain scale) and 0.3 immediately posttreatment. CONCLUSION: A single noninvasive acoustic subcision session can safely provide meaningful improvement in the appearance of cellulite in terms of depressions, as well as skin laxity, with minimal treatment pain and no posttreatment down time. Further improvement in appearance is expected with multiple treatments over time. Additional trials to verify this are planned.

Multimodal Facial Aesthetic Treatment on the Appearance of Aging, Social Confidence, and Psychological Well-being: HARMONY Study.

BACKGROUND: A global approach to facial rejuvenation involves multiple treatment modalities. OBJECTIVES: The aim of this study was to evaluate the impact of multimodal facial aesthetic treatment on self-reported psychological and social outcomes. METHODS: HARMONY, a prospective, multicenter, 4-month study, enrolled patients aged 35 to 65 years to receive on-label treatment with a combination of hyaluronic fillers (VYC-20L, HYC-24L, and/or HYC-24L+), onabotulinumtoxinA, and bimatoprost. Fillers were injected on Day 1, with touch-ups performed on Day 14. OnabotulinumtoxinA was injected at Month 3 into glabellar lines and/or crow's feet lines. Patients applied bimatoprost to eyelashes once daily for 17 weeks. Mean change from baseline on FACE-Q Psychological Well-being and Social Confidence Scales, FACE-Q Aging Appearance Appraisal Scale, and FACE-Q Age Appraisal Visual Analog Scale were assessed. RESULTS: Of 100 patients treated, 93 were evaluated at 4 months posttreatment. Significant improvement vs baseline was observed on the FACE-Q Scales for Psychological Well-being (mean change, -19.9; P < 0.00001), Social Confidence (mean change, -18.2; P < 0.00001), and Aging Appearance (mean change, -28.5; P < 0.0001). On average, patients' self-assessed age was 0.1 years older than actual age at baseline and 4.5 years younger at Month 4 (P < 0.001 vs baseline). Forty-two patients experienced adverse events, all mild to moderate. CONCLUSIONS: Multimodal, full facial aesthetic treatment improves patients' self-reported psychological well-being, social confidence, aging appearance, and perceptions of chronologic age.

Cytrellis: A Novel Microcoring Technology for Scarless Skin Removal: Summary of Three Prospective Clinical Trials.

BACKGROUND: We introduce an innovative and novel technology that achieves scarless skin removal without the use of thermal energy. Microcoring technology (MCT) uses a modified, hollow hypodermic needle to remove skin safely and without a scar. This method is advantageous compared to other fractional devices, given that it has the same benefits as energy-based devices (removal of skin cores without a scar), with the added value of immediate closure along the relaxed skin tension lines, with significantly less thermal energy. METHODS: Three prospective clinical safety trials analyzing MCT treatment on abdominal and facial skin (short- and long-term) are described. RESULTS: MCT treatment of human skin resulted in scarless skin removal that was well tolerated by patients. Healing occurred rapidly, with limited side effects. Skin area reduction (skin tightening) and increase in skin thickness were observed long term. CONCLUSIONS: MCT treatment of human skin is safe and well tolerated. Although further studies on efficacy are required to evaluate the full potential of MCT in skin rejuvenation, early findings such as skin tightening and increase in skin thickness are encouraging.

Injection Cryolipolysis: First-in-human Study.

BACKGROUND: Injection cryolipolysis using an ice slurry has been hypothesized to be a novel method of reducing fat. The present first-in-human pilot study aims to investigate the feasibility, safety, and tolerability of ice slurry injection into human subcutaneous fat. METHODS: Preabdominoplasty subjects were recruited. Baseline measurements and serial follow-up visits following a single ice slurry injection procedure into tissue to be excised during abdominoplasty were performed. Melted ice slurry injection was used as control. Feasibility using standard injection techniques was assessed. Thermal imaging was used to determine cooling efficacy. Safety was assessed by adverse event monitoring. Tolerability was assessed by subject-reported pain score. Histology and ultrasound were monitored for structural changes associated with cryolipolysis. RESULTS: A single injection of ice slurry was feasible and sufficient to cool adipose below the target temperature (10C). There were no serious adverse events. The most common adverse events were bruising and erythema. The mean pain score for ice slurry-injected sites was 1.9/10 and 1.3/10 in control injection sites. Evidence of cryolipolysis was observed on ultrasound and tissue histology in ice slurry-injected sites. CONCLUSIONS: Ice slurry injections are feasible, with an observed safety and tolerability profile comparable to topical cryolipolysis. The ice slurry can cool tissue to induce cryolipolysis, as observed by thermal imaging, ultrasound, and tissue histology, and is selective for ice-injected sites. No significant changes were observed in control sites. The ice slurry may be a promising candidate to enable more precise, effective, and customizable aesthetic fat reduction that warrants further investigation.

Collagenase Clostridium Histolyticum-aaes for the Treatment of Cellulite in Women: Results From Two Phase 3 Randomized, Placebo-Controlled Trials.

BACKGROUND: Fibrous septae play a role in contour alterations associated with cellulite. OBJECTIVE: To assess collagenase clostridium histolyticum-aaes (CCH) for the treatment of cellulite. MATERIALS AND METHODS: Two identically designed phase 3, double-blind, randomized studies (RELEASE-1 and RELEASE-2) were conducted. Adult women with moderate/severe cellulite (rating 3-4 on the Patient Reported Photonumeric Cellulite Severity Scale [PR-PCSS] and Clinician Reported PCSS [CR-PCSS]) on the buttocks received up to 3 treatment sessions of subcutaneous CCH 0.84 mg or placebo per treatment area. Composite response (≥2-level or ≥1-level improvement from baseline in both PR-PCSS and CR-PCSS) was determined at Day 71. RESULTS: Eight hundred forty-three women received ≥1 injection (CCH vs placebo: RELEASE-1, n = 210 vs n = 213; RELEASE-2, n = 214 vs n = 206). Greater percentages of CCH-treated women were ≥2-level composite responders versus placebo in RELEASE-1 (7.6% vs 1.9%; p = .006) and RELEASE-2 (5.6% vs 0.5%; p = .002) and ≥1-level composite responders in RELEASE-1 (37.1% vs 17.8%; p < .001) and RELEASE-2 (41.6% vs 11.2%; p < .001). Most adverse events (AEs) in the CCH group were injection site related; few CCH-treated women discontinued because of an AE (≤4.3%). CONCLUSION: Collagenase clostridium histolyticum-aaes significantly improved cellulite appearance and was generally well tolerated.

Insights Into the Pathophysiology of Cellulite: A Review.

BACKGROUND: The etiology of cellulite is unclear. Treatment of cellulite has targeted adipose tissue, dermis, and fibrous septae with varying degrees of success and durability of response. OBJECTIVE: Results from clinical trials that target different anatomical aspects of cellulite can provide insights into the underlying pathophysiology of cellulite. MATERIALS AND METHODS: A search of the PubMed database and ClinicalTrials.gov website was conducted to identify clinical trials that have investigated treatments for cellulite. RESULTS: A lack of trial protocol standardization, objective means for quantification of improvement and reported cellulite severity, and short-term follow-up, as well as variation in assessment methods have made comparisons among efficacy studies challenging. However, the lack of durable efficacy and inconsistency seen in clinical results suggest that dermal or adipose tissue changes are not the primary etiologies of cellulite. Clinical studies targeting the collagen-rich fibrous septae in cellulite dimples through mechanical, surgical, or enzymatic approaches suggest that targeting fibrous septae is the strategy most likely to provide durable improvement of skin topography and the appearance of cellulite. CONCLUSION: The etiology of cellulite has not been completely elucidated. However, there is compelling clinical evidence that fibrous septae play a central role in the pathophysiology of cellulite.

CME: Re-examining the Optimal Use of Neuromodulators and the Changing Landscape: A Consensus Panel Update.

Since initial US Food and Drug Administration approval of botulinum toxin type A (BoNT-A) for aesthetic use in 2002, clinical evidence and experience with BoNT-A and understanding of facial anatomy have greatly increased, leading to rapid advances in treatment planning and implementation. BoNT-A use has expanded from the upper face to the midface, lower face, and neck, so that BoNT-A injection is the most common cosmetic procedure worldwide. Trends in facial aesthetics reflect growing patient diversity with respect to age, gender, and ethnicity. In October 2019, a multidisciplinary panel of 6 experts in minimally invasive injectable procedures in the specialties of dermatology and plastic surgery convened at the 2019 American Society for Dermatologic Surgery (ASDS) meeting in Chicago, IL. Their goal was to discuss recent advances in BoNT-A use in facial aesthetics, including implications of the introduction of new agents in light of an evolving patient population. J Drugs Dermatol. 2020;19(4 Suppl 1):s5-15To receive a CME certificate of participation, you should: •Read the entire publication, including the CME information. •Register or log in at www.paradigmmc.com/822 to complete and submit the online posttest and evaluation. Following online completion of the posttest and evaluation, a certificate of participation will be available for download/printing immediately.Erratum published for this article here.

Re-examining the Optimal Use of Neuromodulators and the Changing Landscape: A Consensus Panel Update

Since initial US Food and Drug Administration approval of botulinum toxin type A (BoNT-A) for aesthetic use in 2002, clinical evidence and experience with BoNT-A and understanding of facial anatomy have greatly increased, leading to rapid advances in treatment planning and implementation. BoNT-A use has expanded from the upper face to the midface, lower face, and neck, so that BoNT-A injection is the most common cosmetic procedure worldwide. Trends in facial aesthetics reflect growing patient diversity with respect to age, gender, and ethnicity. In October 2019, a multidisciplinary panel of 6 experts in minimally invasive injectable procedures in the specialties of dermatology and plastic surgery convened at the 2019 American Society for Dermatologic Surgery (ASDS) meeting in Chicago, IL. Their goal was to discuss recent advances in BoNT-A use in facial aesthetics, including implications of the introduction of new agents in light of an evolving patient population. J Drugs Dermatol. 2020;19(4 Suppl 1):s5-15 To receive a CME certificate of participation, you should: •Read the entire publication, including the CME information. •Register or log in at www.paradigmmc.com/822 to complete and submit the online posttest and evaluation. Following online completion of the posttest and evaluation, a certificate of participation will be available for download/printing immediately.

A multi-center, open-label, pilot study of allograft adipose matrix for the correction of atrophic temples.

BACKGROUND: Autologous fat grafting (AFG) and synthetic fillers are currently used in esthetic and reconstructive surgery. Challenges in AFG include inconsistent graft retention, donor site morbidities, insufficient harvest, and excessive harvesting times. An allograft adipose matrix (AAM) has been developed as an off-the-shelf alternative to AFG and synthetic fillers. AIMS: To evaluate the clinical safety and retention of an AAM over 24 weeks after treatment of bilateral atrophic temples. PATIENTS/METHODS: Ten subjects (nine females, one male, aged 47-69 years) with temple atrophy were enrolled in the IRB-approved study. AAM (Renuva® , MTF Biologics, Edison, NJ) was injected (<3 mL) bilaterally into the atrophic temples of each subject. Volume retention, global improvement, and safety were evaluated at 1, 4, 8, 12, 16, 20, and 24 weeks. Biopsy specimens were obtained for adipogenic and angiogenic histological evaluation. RESULTS: The mean temple volume improved over the baseline and was retained throughout the study period. Fullness (measure of volume) increased immediately from 0 pretreatment to 2.8 post-treatment (scale 0-4 = none-maximum). Fullness varied from 0.8 to 2.2 from weeks 1 through 12 and was 2.7-3.0 from weeks 16-24, around 75% increase from baseline. Furthermore, skin tone, smoothness, texture, and overall appearance also improved with 71% of subjects being satisfied to very satisfied with the results. Adverse events were minimal and histology revealed native tissue incorporation and remodeling. CONCLUSION: AAM is safe and well tolerated, provides at least 6-month volume retention, improves skin quality, and supports adipose tissue remodeling after treatment into temples.

L.E.A.P.ing into the cosmetic consult.

Establishing good rapport with patients is important during the initial consult, especially in aesthetic medicine. While experienced physicians develop expertise in cultivating a positive patient experience, younger physicians may benefit from some guidance. We describe the L.E.A.P (Listen, Educate and Empower, Align, Perform) method which may help guide young physicians through a successful cosmetic consult. In addition we will review the B.L.A.S.T (Believe, Listen, Apologize, Satisfy, Thank) method for dealing with unhappy patients.

Increased Tattoo Fading in a Single Laser Tattoo Removal Session Enabled by a Rapid Acoustic Pulse Device: A Prospective Clinical Trial.

BACKGROUND AND OBJECTIVES: The ability to provide improved tattoo fading using multiple laser passes in a single office laser tattoo removal session is limited. In part, this is due to the loss of laser effectiveness caused by epidermal and dermal vacuole "whitening" generated during the initial laser pass at the tattoo site. The Rapid Acoustic Pulse (RAP) device generates acoustic shock wave pulses that clear epidermal and dermal vacuoles to enable multiple laser passes in a single office laser tattoo removal session. The objectives of this study were to determine if the RAP device, when used as an accessory to the 1064 nm Nd:YAG Q-switched (QS) laser can enable delivery of multiple laser passes in a single office laser tattoo removal session, and therefore result in increased tattoo fading compared to the clinical standard single-pass QS laser tattoo removal session. STUDY DESIGN/MATERIALS AND METHODS: The RAP device was evaluated in a single-center (SkinCare Physicians), prospective, IRB approved study. A total of 32 black ink tattoos, from 21 participants, were divided into three zones and treated with either multiple QS laser passes, each followed by 1 minute of RAP device application (Laser + RAP) in zone one and single-pass QS laser treatment (Laser-Only) in zone two, separated by an untreated control zone. The treatment sites were assessed for the number of laser passes and adverse events immediately, 6 weeks, and 12 weeks following the treatment session. Photographs of the treatment sites were assessed for percent fading at 12 weeks post-treatment by three blinded reviewers. RESULTS: When the RAP device was applied as an accessory to the QS laser in a multi-pass laser tattoo removal treatment, an average of 4.2 laser passes were delivered in a single session, with no unexpected or serious RAP device-related adverse events. At the 12-week follow-up, tattoos treated with Laser + RAP showed a statistically significant increase in average fading (44.2%) compared with tattoos treated with Laser-Only (24.8%) (P < 0.01). Additionally, a significantly higher overall proportion of tattoos treated with Laser + RAP (37.5%) had a response of >50% fading compared with tattoos treated with QS Laser-Only (9.4%) (P < 0.01) as well as a response of >75% fading from Laser + RAP treatment (21.9%) compared with Laser-Only treatment (3.1%) (P < 0.05). CONCLUSIONS: The RAP device, applied as an accessory to the 1064 nm Nd:YAG QS laser, safely enables multiple QS laser treatments in a single office laser tattoo removal session by clearing the whitening caused by the previous QS laser pass. Enabling multiple QS laser passes results in a statistically significant increase in tattoo fading in a single office laser tattoo removal session compared to the clinical standard single-pass QS laser tattoo removal session. © 2019 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.