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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 Results Seventy-four female participants with a mean BMI of 24.8 ± 2.7 and age of 41.4 ± 7.4 years received this single procedure. The mean improvement in Cellulite Severity Scale (N = 68) was 1.5 ± 0.9 (P 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. Level of Evidence: 2

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. Level of Evidence: 2

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.

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.

Supplemental Digital Content is Available in the Text., 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.

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. Level of Evidence: 4

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.

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.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.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];CCH-aaes treatment significantly improved moderate-to-severe buttock cellulite appearance and was generally well tolerated.

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.

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 50% fading compared with tattoos treated with QS Laser‐Only (9.4%) (P 75% fading from Laser + RAP treatment (21.9%) compared with Laser‐Only treatment (3.1%) (P

Cellulite is a common female cosmetic concern for which there are few treatment options with long-term effectiveness data. The aim of this multisite prospective registry study was to collect observational data on the real-life clinical use of a tissue stabilized-guided subcision (TS-GS) system for long-term improvement of cellulite appearance.Fifty-three subjects were enrolled and received a single treatment using the TS-GS system. Physicians treated the subjects according to their standard of care. Global Aesthetic Improvement Scale (GAIS) was completed by the patient and clinician assessing overall aesthetic improvement after 180 days. Treatment parameters, pain scores, quality of life data, and expected treatment effects and adverse events were also recorded throughout the study.The patient and physician GAIS scores at Day 180 revealed an overall improvement in 91% and 96% of patients, respectively. Quality of life and self-confidence scores also improved through 180 days. No serious adverse events were reported. Expected treatment effects were similar to those reported in the pivotal trial supporting FDA clearance.This study demonstrated significant improvement in the appearance of cellulite after a single treatment session in patients with moderate-to-severe cellulite. These results are consistent with the previously published the pivotal study data.

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. Level of Evidence: 4

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 (

Background Aesthetic medicine has evolved from targeting individual treatment areas to a global approach of panfacial rejuvenation. HARMONY was the first clinical study to systematically demonstrate positive physical and psychosocial impacts of panfacial treatment. Objective Provide evidence-based guidance on treatment strategies to help maximize outcomes in patients seeking panfacial rejuvenation. Materials and methods Study sites with the lowest (n = 2) and highest (n = 2) improvements based on FACE-Q Satisfaction with Face Overall scores were analyzed to understand differences in treatment strategy that may contribute to incrementally greater patient satisfaction. Results The highest scoring sites exhibited greater improvement in all patient-reported outcomes and investigator-assessed measures related to dermal filler treatment compared with the lowest scoring sites. The highest sites favored lateral malar augmentation and used less volume medially versus the lowest sites. In the lower face, the highest sites used greater volumes and more HYC-24L than HYC-24L+. Initial treatment volumes were more conservative at highest than lowest sites; greater volumes were used by highest sites in touch-up treatments. Conclusion Product usage trends common to the highest scoring sites (including injection volume, injection sites, and product selection) may provide guidance on best practices for a panfacial approach to aesthetic treatment to maximize patient satisfaction.

Cellulite is a condition that affects the majority of postpubertal women and can negatively impact quality of life. This review discusses several proposed pathophysiologies of cellulite, and examines treatment options that have been utilized, focusing on the etiologic factor targeted by the therapies. This approach aims to help clarify the pathogenesis of cellulite and provide a road map for developing effective treatment paradigms for patients.

Background New treatment methods for cellulite require globally accepted scales for aesthetic research and patient evaluation. Objective To develop a set of grading scales for objective assessment of cellulite dimples on female buttocks and thighs and assess their reliability and validity. Materials and methods Two photonumeric grading scales were created and validated for dimples in the buttocks in female patients: Cellulite Dimples-At Rest, and Cellulite Dimples-Dynamic. Sixteen aesthetic experts rated photographs of 50 women in 2 validation sessions. Responses were analyzed to assess inter-rater and intra-rater reliability. Results Overall inter-rater reliability and intra-rater reliability were both "almost perfect" (≥0.81, intraclass correlation efficient and weighted kappa) for the At Rest scale. For the Dynamic scale, inter-rater reliability and intra-rater reliability were "substantial" (0.61-0.80). There was a high correlation between the cellulite scales and body mass index, age, weight, and skin laxity assessments. Conclusion Consistent outcomes between raters and by individual raters at 2 time points confirm the reliability of the cellulite dimple grading scales for buttocks and thighs in female patients and suggest they will be a valuable tool for use in research and clinical practice.

Robust and long-term data on true incidence of delayed-onset nodules and immune tolerance of hyaluronic acid (HA) fillers are lacking.To characterize the incidence of delayed nodules in Vycross (VYC) HA fillers compared with previously reported FDA and non-FDA data of all HA fillers.The incidence of delayed nodules in all patients who had received VYC fillers in a 12-month period was assessed through a retrospective chart review. Nodule incidence for currently approved nonanimal-stabilized hyaluronic acid (NASHA) fillers was assessed using the FDA Summary of Safety and Effectiveness Data.Overall, 1,029 patients received 1,250 VYC filler treatments. Five patients developed delayed nodules to VOB, with an incidence of 1.0% per patient and 0.8% per syringe. No nodules were observed in patients who received VLR or VOL. All nodules were treated successfully using a combination of intralesional triamcinolone and hyaluronidase. Compared with other currently approved NASHA fillers, VOB is associated with a higher incidence of nodule formation.The introduction of VYC HAs has introduced a new variable that may be changing the immune tolerance of these substances, resulting in a higher incidence of delayed nodules than previously expected.

This study was performed to investigate gender differences in gluteal subcutaneous architecture and biomechanics to better understand the pathophysiology underlying the mattress-like appearance of cellulite.Ten male and 10 female body donors [mean age, 76 ± 16.47 years (range, 36 to 92 years); mean body mass index, 25.27 ± 6.24 kg/m (range, 16.69 to 40.76 kg/m)] were used to generate full-thickness longitudinal and transverse gluteal slices. In the superficial and deep fatty layers, fat lobule number, height, and width were investigated. The force needed to cause septal breakage between the dermis and superficial fascia was measured using biomechanical testing.Increased age was significantly related to decreased dermal thickness, independent of sex (OR, 0.997, 95 percent CI, 0.996 to 0.998; p0.0001). The mean number of subdermal fat lobules was significantly higher in male body donors (10.05 ± 2.3) than in female body donors (7.51 ± 2.7; p = 0.003), indicating more septal connections between the superficial fascia and dermis in men. Female sex and increased body mass index were associated with increased height of superficial fat lobules. The force needed to cause septal breakage in male body donors (38.46 ± 26.3 N) was significantly greater than in female body donors (23.26 ± 10.2 N; p = 0.021).The interplay of dermal support, septal morphology, and underlying fat architecture contributes to the biomechanical properties of the subdermal junction. This is influenced by sex, age, and body mass index. Cellulite can be understood as an imbalance between containment and extrusion forces at the subdermal junction; aged women with high body mass index have the greatest risk of developing (or worsening of) cellulite.

Cellulite is a common dermatologic condition and frequent cause of cosmetic concern among women. This paper aims to update what is known about the pathogenesis of cellulite and reviews targeted treatment modalities that address its underlying components of microvascular dysfunction, endocrine-mediated inflammation, and connective tissue fibrosclerosis.

Background Cellulite can be significantly improved using vacuum-assisted tissue stabilized-guided subcision (TS-GS). However, the treatment of shallow and linear cellulite has remained problematic. Objective In this retrospective study, we describe a modified technique of vacuum-assisted TS-GS. The aim is to demonstrate that this new limited-release technique is an effective treatment for long ripples and interconnected shallow dimples, which are characteristic of mild-to-moderate cellulite. Methods Patients with mild-to-moderate cellulite were treated with limited-release vacuum-assisted TS-GS. All subcisions were performed at the 6-mm depth and a minimum of 3 mm between each dimple. Using a 4-point scale, 2 raters graded cellulite improvement on evaluation of prephotographs and postphotographs. Results A total of 23 female patients were included in this study. The pre- and post-treatment photographs were correctly identified in 22 of the 23 patients (95.6%). The average cellulite improvement was 2.9 of 4 for the buttocks and 2.8 of 4 for the posterior thighs. Global cellulite improvement was reported at 3.1 of 4. Conclusion The results demonstrate that modified, limited-release, vacuum-assisted TS-GS can be an effective and safe method for the treatment of long ripples and shallow dimples that are characteristics of mild-to-moderate cellulite.

Background Individuals seeking aesthetic treatment have concerns regarding multiple facial areas. Objectives Assess the aesthetic impact and satisfaction achieved with a multimodal approach to aesthetic treatment using a combination of minimally invasive treatments. Methods Prospective, multicenter, rater-blinded, 4-month HARMONY study evaluated patient satisfaction and aesthetic impact of a combination of fillers (VYC-20L, HYC-24L, and HYC-24L+), onabotulinumtoxinA, and bimatoprost. Males and females aged 35 to 65 years received on-label, staged treatment with fillers, as needed per investigator assessment, on day 1, with touch ups allowed on day 14. Bimatoprost was self-administered once daily for 17 weeks. OnabotulinumtoxinA was injected into glabellar lines, crow's feet lines, or both at month 3. Primary effectiveness measure was mean change from baseline on the FACE-Q 10-item Satisfaction with Facial Appearance Overall Scale. Results Of 100 patients treated, 93 underwent at least the 4-month posttreatment assessment and were assessed for efficacy. The FACE-Q Satisfaction with Facial Appearance Overall Scale total score increased from baseline (41.2) to month 4 (72.9; P < 0.00001; effect size, 2.7). Improvement following multimodal treatment was observed on FACE-Q individual items. Self-perceived age decreased from 0.2 years older than actual age at baseline to 4.6 years younger at month 4. Nearly all patients (99%) rated themselves as improved or much improved on the Global Aesthetic Improvement Scale. Investigator assessments also demonstrated improvement. Mild to moderate adverse events occurred in 42 patients. Conclusions Minimally invasive, multimodal treatment resulted in improvements in FACE-Q scores and perceived age, indicating a high degree of patient satisfaction and a younger facial appearance. Level of Evidence 4

Cellulite is a common female cosmetic concern for which no single treatment option had been proven effective over the long term. A novel tissue stabilized-guided subsicion system (TS-GS system) has demonstrated significant reduction in the appearance of cellulite after treatment.The objective of this extended follow-up period was to assess the effectiveness of TS-GS out to 3 years after initial treatment.After completing an open-label, multicenter, pivotal study, 45 subjects were followed for an extended period of up to 3 years after receiving a single treatment using the TS-GS system. Treatment areas were photographed prior to the procedure and at multiple time points post-treatment throughout the 3 years. In this open-label study, subjects served as their own controls. Effectiveness was assessed based on blinded independent physician panel assessments of improvement from baseline using a cellulite severity scale. Subject aesthetic improvement and patient-reported satisfaction were also collected.The results of this trial supported Food and Drug Administration clearance of the device for the long-term reduction in the appearance of cellulite following TS-GS.These data further demonstrate the safety and efficacy of this treatment with no reduction in treatment benefits out to 3 years.

Background Fractionated technology has revolutionized laser therapy. With the success of initial devices, several fractionated lasers have appeared on the market. Claims of superiority have made device choice difficult for physicians and patients. Materials and Methods Twelve subjects were treated with fractionated ablative lasers (10,600-nm carbon dioxide and 2790-nm yttrium scandium gallium garnet) in this institutional review board–approved trial. Each face was divided into four quadrants, and each quadrant was randomly treated using one of four lasers. Clinical experience was used to optimize settings. Two patients submitted biopsies from each quadrant immediately after treatment. Patients and blinded investigators assessed pain during treatment and post-treatment improvement in photoaging (measured by rhytides, lentigines, texture, and pore size) using a five-point scale. Results All devices resulted in statistical improvement in photoaging in all patients, but no device was statistically significantly superior. No statistically significant difference was found in pain scores. All patients reported satisfaction 1 month after treatment. Three patients experienced adverse reactions. Histologically, there were no statistically significant differences between devices. Conclusions Fractionated ablative lasers reliably result in improvement in photoaging. Despite marketing claims, no statistically significant differences were found in outcomes, pain during treatment, or histologic findings. Even with experienced users, significant adverse reactions are possible.

Duration of effect and effectiveness limit current options for treating axillary hyperhidrosis. A new microwave procedure for treatment of axillary hyperhidrosis has been tested.Adults with primary axillary hyperhidrosis were enrolled in a randomized, sham-controlled, blinded study. Subjects were required to have a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 and baseline sweat production greater than 50 mg/5 min. Procedures were administered using a proprietary microwave energy device that isolates and heats target tissue. Responders were defined as subjects reporting a HDSS score of 1 or 2. Subjects were followed for 6 months (sham group) or 12 months (active group).Thirty days after treatment, the active group had a responder rate of 89% (72/81), and the sham group had a responder rate of 54% (21/39) (P.001). Treatment efficacy was stable from 3 months (74%) to 12 months (69%), when follow-up ended. Adverse events were generally mild, and all but one resolved over time.The procedure demonstrated statistically significant, long-term efficacy in sweat reduction. As with any new procedure, findings from this first investigational device study identified optimization strategies for the future.

Cellulite is a condition that affects the vast majority of women. Although it is of no danger to one's overall health, cellulite can be psychosocially debilitating. Consequently, much research has been devoted to understanding cellulite and its etiopathogenesis. With additional insights into the underlying causes of its clinical presentation, therapeutic modalities have been developed that offer hope to cellulite sufferers. This review examines evidence for topical treatments, noninvasive energy-based devices, and recently developed minimally invasive interventions that may finally provide a solution.

The thread lift is a minimally invasive procedure that uses barbed sutures, inserted subcutaneously, to produce lifting of ptotic tissue of the face and neck. There are currently very limited data on longevity and patient satisfaction following barbed suture lifting procedures.The purpose of this study was to assess long-term efficacy following the use of barbed sutures.A satisfaction survey was mailed to 20 patients who were a minimum of 6 months (range, 6 to 16 months) postprocedure. Physician assessment of pre- and postprocedure photographs was also performed.At an average of 11.5 months postprocedure, patients felt that the barbed suture lift met their expectations, rating their satisfaction a 6.9 on a scale of 1 to 10. Independent physicians rated the overall improvement an average of 4.6 of 10. Higher scores were noted in Zone 1 (tear trough/malar fat pad and nasolabial folds) compared to Zone 2 (marionette lines, jowls, and jawline definition) and Zone 3 (platysmal bands and neck contour).The barbed suture lift procedure provides moderate long-term and sustained improvement for facial laxity, with most improvement seen in the tear trough/malar fat pads and nasolabial folds. In this study, clinical efficacy was seen up to 16 months postprocedure.

BACKGROUND Pulsed dye laser has been used to decrease erythema and telangiectasia associated with scars, including surgical scars. There is limited evidence indicating improved surgical scar appearance if pulsed dye laser treatments are commenced immediately at the time of suture removal. OBJECTIVE To determine whether a single one-pass pulsed dye laser treatment at the time of suture removal can improve the appearance of surgical scars. METHODS Randomized controlled trial enrolling 20 patients (complete data for 17 patients) at two geographic sites, with blinded ratings of pre- and post-treatment photographs obtained at various time points. Included patients underwent elliptical excision for atypical nevi of the trunk and/or extremities, with at least one resulting scar of at least 5 cm in length or two scars of at least 2.5 cm in length. For each patient, each scar or half-scar (if a larger scar was used) was randomized to treatment or control groups. Treatment scars received a single one-pass treatment with a 595 nm pulsed dye laser (Vbeam, Candela Corporation, Wayland, MA, USA) at the time of suture removal (ie, 2 weeks after excision) at the following parameters: 7 J/cm2 fluence, 7 mm spot size, 1.5-millisecond pulse duration, and 30-millisecond spray, 20-millisecond delay of dynamic cooling. The treatment area included 1 cm on either side of the scar, and the round laser spots were overlapped 10%. Control scars were not treated with laser. RESULTS Immediate purpura was induced from the laser treatment. Six weeks after laser treatment, no significant difference was found in the clinical appearance of surgical scars treated with a single pulsed dye laser treatment on suture removal day versus those surgical scars not treated with laser. Parameters on which no significant difference was found included visibility of incision, erythema, hyperpigmentation, hypopigmentation, induration, and atrophy. Both sets of scars improved over time. CONCLUSIONS A single pulsed dye laser treatment at the time of suture removal does not appear to have a beneficial effect on clinical scar appearance. The point of minimal benefit for such laser treatments may lie somewhere between one and three treatments.

Cellulite refers to the dimpled appearance of skin occurring where the dermis is tethered by subcutaneous fibrous septa arranged perpendicularly to the skin surface.To demonstrate the safety and efficacy of a new system for vacuum-assisted precise tissue release for the treatment of cellulite.Adult women with moderate to severe cellulite (N = 55) underwent a single treatment. Post-treatment assessments were performed after 3 and 14 days; 1, 3, and 6 months; and at 1 year. Outcome measures included blinded assessments of subject photographs, a validated Cellulite Severity Scale (CSS), and the Global Aesthetic Improvement Scale. Subject satisfaction and pain ratings were also recorded.The mean baseline CSS score of 3.4 decreased to 1.3 at 3 months (p.0001) and 1.4 at 1 year (p.0001), with 47 subjects (93%) having ≥1-point improvements. Subject satisfaction was 85% at 3 months and 94% at 1 year. Transient treatment-related adverse events were mild in severity.This study demonstrates the safety, efficacy, and subject satisfaction with vacuum-assisted precise tissue release in the treatment of cellulite. There was no reduction in treatment benefits for up to 1 year. These results supported the Food and Drug Administration clearance of the device for the long-term reduction in the appearance of cellulite.

Over the last 50 years, laser sources have been used in many skin diseases, and their role has been increasing in most fields of dermatology. At present, laser technology allows us to treat a variety of skin conditions, either inflammatory or neoplastic, in addition to aesthetic problems. Hence, in the last few years, surgical, vascular, selective, and other lasers have become more popular. A significant advantage of lasers is their ability to provide “noncontact surgery,” since lesion vaporization occurs without any physical contact between skin and the device. This assures sterilization and helps avoid possible infections. The different types of laser treatments have been expanding as well as laser technology. A better understanding of interactions between laser radiation and tissues has made lasers more powerful and selective for each type of lesion and aesthetic problem. Due to the specific properties of selective photothermolysis, lasers exert effects strictly limited to the treated area, avoiding any damage to the surrounding skin. This unique attribute of lasers allows physicians to treat even very small skin lesions with excellent aesthetic results. In particular, in the vascular field, dye lasers have become the gold standard in treating superficial vascular disease and are excellent for treating large lesions such as port wine stains. Pulsed dye lasers are also useful tools for the so-called unconventional treatments, such as hypertrophic scars, keloids, superficial basal cell carcinoma, and common warts. ND-Yag lasers are used for treating deep vascular lesions and hair removal. In addition, these two lasers can also be employed effectively in combination on difficult lesions, as reported by K. Vas et al., showing that sequential combined treatment with both dye and ND-Yag lasers is satisfactory for surgical scars. Another popular device is the Q-switched laser, which is effective and safe for removal of benign pigmented lesions and tattoos since it interacts with the dermal structures holding exogenous pigment. Tattoo removal may be associated with a number of cutaneous side effects, such as inflammatory or rare neoplastic skin reactions, which are described by A. Bassi et al. They highlight that early diagnosis is essential for proper treatment. Intense pulsed light is a versatile tool suitable for many different skin conditions thanks to its wide range of wavelengths, and unconventional uses are exhaustively discussed by D. Piccolo et al. The constant improvement in laser devices and technology results in the need for continuous training and evolving knowledge. For example, A. Soriani et al. highlight this concept with a study that examines the power loss of laser beams induced by various types of tissue. Since laser penetration is closely related to laser settings such as wavelength and spot diameter, they evaluate these variables in order to accurately determine the fraction of released energy in order to obtain better clinical results. Due to the increasing need for noninvasive technology for diagnosis, therapy, and follow-up, high resolution tools such as nonlinear optical microscopy and two-photon fluorescence microscopy are in depth presented by R. Cicchi et al. They evaluate possibilities to monitor the effect of therapy and topical absorption. Since the 1970s, photodynamic therapy aroused a growing interest in treating several skin diseases. E. Filonenko et al. evaluate the effectiveness of this treatment for penile in situ carcinoma, obtaining satisfactory oncological results without affecting patient quality of life. In addition, X. Wang et al. emphasize that these therapies may require long application times so that the use of an automatic medical manipulator system can increase the radiation uniformity and ensure a better therapeutic result. Due to the growing importance of laser techniques in dermatologic practice, ongoing multicenter studies will be valuable in helping us develop precise standardization of parameters used for each laser and each disease. This will improve the effectiveness of the tools and allow physicians to obtain better and more reproducible results. Silvia Moretti Michael S. Kaminer Anne Le Pillouer-Prost Piero Campolmi

Background Cosmetic dermatologic procedures offer the promise of visible aesthetic enhancement with minimal risk. While in recent years the number of available procedures has proliferated, there are few objective methods for evaluating the relative quality of these procedures for particular indications or specific patients. Objective (A) To develop a simple, easy-to-use numerical rating scale to assess the quality of cosmetic surgical procedures on a range of parameters pertaining to clinical efficacy and patient satisfaction; (B) to statistically validate the discriminative value of this rating scale. Methods (A) Patient and physician interviews were performed to elicit a list of factors that may collectively characterize the clinical efficacy and patient tolerability of cosmetic dermatologic procedures. A 0-100 point rating scale was developed based on these factors, with the face-validity of this scale checked by a group of patients and physicians; (B) Statistical analysis of the questionnaire was performed by asking 15 expert cosmetic dermatologic surgeons to use it to rate 23 common cosmetic dermatologic procedures, and analyzing the results. Results (A) An easy-to-use scale was constructed to assess the quality of cosmetic dermatologic procedures by rating the associated cost, risk, time (procedure and recovery), discomfort, results, and longevity of benefit. A "physician adjustment factor" was used to further increase the relevance of this 0-100 point scale for specific patients; (B) Repeated-measures analysis of variations (ANOVAs) performed on the data from the survey of experts demonstrated that this scale can be used to discriminate between common dermatologic procedures. The differences in mean subscores and total scores among procedures grouped by anatomic site and target lesion-type were significant at the level of P Limitations Patient preferences exogenous to the rating scale may increase or decrease the suitability of specific procedures. Conclusions Common cosmetic dermatologic procedures are of uniformly high quality, as per expert ratings on a systematic measure. This quality rating scale appears statistically valid and robust, given that expert raters assigned similar ratings to the same procedures but mean ratings were different across procedures. In the future, this quality rating scale can be used to assess novel interventions, and to help dermatologic surgeons faced with patient concern to optimally select among alternative procedures for a given indication.

Importance Common noninvasive to minimally invasive cosmetic dermatologic procedures are widely believed to be safe given the low incidence of reported adverse events, but reliable incidence data regarding adverse event rates are unavailable to date. Objective To assess the incidence of adverse events associated with noninvasive to minimally invasive cosmetic dermatologic procedures, including those involving laser and energy devices, as well as injectable neurotoxins and fillers. Design, Setting, and Participants A multicenter prospective cohort study (March 28, 2011, to December 30, 2011) of procedures performed using laser and energy devices, as well as injectable neurotoxins and soft-tissue augmentation materials, among 8 geographically dispersed US private and institutional dermatology outpatient clinical practices focused on cosmetic dermatology, with a total of 23 dermatologists. Participants represented a consecutive sample of 20 399 cosmetic procedures. Data acquisition was for 3 months (13 weeks) per center, with staggered start dates to account for seasonal variation. Exposures Web-based data collection daily at each center to record relevant procedures, by category type and subtype. Adverse events were detected by (1) initial observation by participating physicians or staff; (2) active ascertainment from patients, who were encouraged to self-report after their procedure; and (3) follow-up postprocedural phone calls to patients by staff, if appropriate. When adverse events were not observed by physicians but were suspected, follow-up visits were scheduled within 24 hours to characterize these events. Detailed information regarding each adverse event was entered into an online form. Main Outcomes and Measures The main outcome was the total incidence of procedure-related adverse events (total adverse events divided by total procedures performed), as verified by clinical examination. Results Forty-eight adverse events were reported, for a rate of 0.24% (95% CI, 0.18%-0.31%). Overall, 36 procedures resulted in at least 1 adverse event, for a rate of 0.18% (95% CI, 0.13%-0.25%). No serious adverse events were reported. Adverse events were infrequently associated with known risk factors. Conclusions and Relevance Noninvasive to minimally invasive cosmetic dermatologic procedures, including energy, neurotoxin, and filler procedures, are safe when performed by experienced board-certified dermatologists. Adverse events occur in less than 1% of patients, and most of these are minor and transient.

Background Many devices used in dermatology lack generic names. If investigators use commercial device names, they risk the appearance of bias. Alternatively, reliance on ad-hoc names and abbreviations may confuse readers who do not recognize these. Objective To develop a system for assigning abbreviations to denote devices commonly used in dermatology. Secondarily, to use this system to create abbreviations for FDA-approved neurotoxins and prepackaged injectable soft-tissue augmentation materials. Methods The American Society for Dermatologic Surgery convened a Lexicon Task Force in March 2012. One charge of this Task Force was to develop criteria for assigning abbreviations to medical devices. A modified consensus process was used. Results Abbreviations to denote devices were to be: based on a standardized approach; transparent to the casual reader; markedly brief; and in all cases, different than the commercial names. Three-letter all caps abbreviations, some with subscripts, were assigned to denote each of the approved neurotoxins and fillers. Conclusion A common system of abbreviations for medical devices in dermatology may avoid the appearance of bias while ensuring effective communication. The proposed system may be expanded to name other devices, and the ensuing abbreviations may be suitable for journal articles, continuing medical education lectures, or other academic or clinical purposes.

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Many patients seeking rejuvenation treatment have readily apparent age-related changes in facial features. Others exhibit more subtle changes that nonetheless can be corrected to achieve a more youthful appearance. In the following article, four specialists in aesthetic dermatology discuss how injectable hyaluronic acid-based fillers and neurotoxins can achieve rejuvenation without surgery.

Acne is a common condition experienced by up to 80% of people between 11 and 30 years of age and by up to 5% of older adults. In some patients, the severe inflammatory response to Propionibacterium acnes results in permanent, disfiguring scars. Over the past several decades, numerous descriptive terms and surgical techniques have been used to diagnose the types, and improve the appearance, of scarring in those persons with acne. We propose a descriptive, simple, universally applicable acne scar classification system that includes 3 scar types: icepick, rolling, and boxcar. We also have developed an effective treatment algorithm for reconstructing and improving the appearance of acne scars including punch excision, punch elevation, subcutaneous incision (Subcision), and laser skin resurfacing. This new classification system for acne scars enables the physician to more precisely identify scar subtypes. Once the scar type has been defined, appropriate and effective treatment protocols can be developed.

Background.With the advent of tumescent liposuction, many advances in cosmetic surgery have occurred. Liposuction of excess adipose tissue from the submental area, jowls, and neck, along with cold steel surgery, has become an attractive alternative to the facelift for cervicomental aesthetic surgery

background Benign familial pemphigus (BFP) is a chronic blistering disease with significant morbidity. Surgical methods are often needed to control flares in difficult cases. objective To describe the response of BFP to vaporization with a pulsed carbon dioxide (CO2) laser. methods A 38-year-old woman with chest and axillary involvement unresponsive to conventional therapy was treated with the UltraPulse 5000 Laser (Coherent Medical Group, Palo Alto, CA). After active sites of BFP showed good response to treatment, we treated uninvolved skin of the left axilla to assess the efficacy of prophylactic therapy. results Treatment of affected areas, except biopsy sites, resulted in clearing of active lesions after 1–2 weeks. We noted striking sparing of the treated areas from developing subsequent disease. The region that was later treated prophylactically has shown minor, asymptomatic recurrence of BFP in less than 5% of the area treated over an 18-month follow-up period. conclusion The pulsed carbon dioxide laser is a useful modality in treatment of BFP. In our patient, prophylactic treatment led to near complete eradication of disease in the treated area. A controlled, larger study is needed to confirm our results, and to determine optimal laser parameters. Long-term effects and duration of remission remain to be determined.

background. Body dysmorphic disorder (BDD) is an under-recognized disorder that affects a sizeable number of patients who seek cosmetic enhancement, in particular liposuction. Understanding and recognizing BDD can positively impact the care delivered to patients. objective. To familiarize physicians with the presenting signs of BDD and present strategies for caring for BDD patients in a liposuction and/or cosmetic surgery practice. methods. Review of currently available literature and diagnostic criteria. results. BDD affects approximately 1% of patients in the United States, but as many as 7 to 15% of patients seeking cosmetic surgery. Patients with BDD will usually demonstrate an obsession with the area they seek treatment of. In addition, patients with BDD present a unique challenge to the liposuction surgeon. conclusions. Physicians who care for patients seeking liposuction or other cosmetic procedures should learn to recognize those who have BDD. Proper recognition and counseling of BDD patients can have a significant positive impact on not only their care but also on the patient-physician relationship. Failure to recognize BDD can, and often does, lead to patient dissatisfaction, as well as difficult future interactions with the BDD patient.