BACKGROUND:Acne vulgaris affects up to 80% of individuals aged 11 to 30 years and is one of the most common diseases in the world. Acne and its sequelae, such as redness, hyperpigmentation, irritation, and scarring, can have a deleterious effect on quality of life. Topical therapies are the standard of care, and compliance is central to success. AIMS:The purpose of the study was to evaluate the efficacy of a novel topical formulation (TASG) for the improvement of acne scar appearance and for reducing hyperpigmentation. PATIENTS/METHODS:This single-center, open-label clinical trial included healthy subjects (n = 27, age range 18 to 45 years) presenting with mild to moderate acne scarring and hyperpigmentation. Study duration was 4 visits over a 12-week period. Product was to be applied twice daily. RESULTS:No significant treatment-related adverse events were noted. Data show that 72.5% of subjects had smoother skin and reduced hyperpigmentation (as per observer grading of photographs) and redness at the final week 12 follow-up visit; subjective questionnaire results showed high patient satisfaction, with overall positive impressions of the product itself and its regular use. CONCLUSIONS:The data show that TASG is a safe and effective therapeutic option for improving the appearance of acne scars and related hyperpigmentation.

Background and ObjectivesThis feasibility study describes the effects of Nano-pulse stimulation (TM) (NPS (TM)) technology using the CellFX (TM) System on acne vulgaris of the back with the objectives of demonstrating safety and effectiveness. The CellFX System applies nanosecond pulses of electrical energy to induce highly localized regulated cell death (RCD) in the cellular structures of the targeted zone with no thermal effect on the tissue and negligible effects on surrounding non-cellular components. Study Design/Materials and MethodsSeventeen subjects were enrolled at two sites with thirteen subjects completing treatment. Three 7 X 7 cm regions containing at least five bacne lesions each were identified, one region treated with the CellFX across three treatment sessions, the second region treated as a sham using microneedle tip placement without delivering energy, and the third as an untreated control. ResultsCellFX-treated areas showed an average reduction of acne lesions of 82% by 90 days post-last procedure. Acne improvement was observed in 100% of CellFX-treated regions compared to 39% improvement in Sham regions and 31% improvement in the control regions. The most common skin effects were erythema and hyperpigmentation observed in 23% and 92% of the subjects, respectively, at the last timepoint. No serious adverse events were reported. ConclusionsCellFX is a safe and effective procedure for clearing back acne.

Abstract Background The high-intensity focused electromagnetic field (HIFEM) procedure is an effective method for noninvasive toning and shaping of buttocks. Objectives To investigate and compare the efficacy of simultaneous application of HIFEM procedure with radiofrequency (RF) heating vs HIFEM standalone procedure on the buttocks. Methods Sixty-seven subjects (21-67 years, BMI 16-34 kg/m2) were recruited and divided into two groups. Group A received simultaneous HIFEM + RF therapy, and group B received standalone HIFEM treatments. All participants underwent four 30-minute bilateral treatments on the buttocks. The MRI was used to evaluate the changes in muscle and fat thickness. Results Data of 32 subjects from group A and 31 subjects from group B were reviewed at 1-month follow-up. On average, subjects from group A showed a 31.3% higher increase in muscle thickness, as shown in the MRI evaluation. The gluteal muscle thickness continued to grow and peaked at a 3-month follow-up, wherein 27 patients were evaluated in each group (n = 54). Group A showed on average +24.7% increase (gluteus maximus +8.5 ± 1.9 mm, medius +6.0 ± 1.1 mm, minimus +2.9 ± 0.8 mm), while group B exhibited only +15.9% increase in muscle thickness (gluteus maximus +5.2 ± 1.1 mm, medius +3.6 ± 1.0 mm, minimus +1.6 ± 0.4 mm). On average, group A showed a 35.6% higher growth in muscle thickness. Treatments were safe and comfortable with high satisfaction rates. No adverse event was reported throughout the study. Conclusions Our results suggest that simultaneous use of HIFEM + RF is safe and significantly more effective for gluteal contouring than the HIFEM procedure alone. Level of Evidence: 2

Background: The safety and efficacy of polymethylmethacrylate (PMMA)-collagen gel for long-lasting correction of mid-face volume deficit was established for 12 months. Objective: To determine the long-term safety, efficacy, and durability of PMMA-collagen gel for midface volume restoration at 24 and 36 months. Methods: This prospective, single-center, 2-year extension study enrolled 22 patients treated with PMMA-collagen gel in the initial study. The primary endpoint was a 2-point improvement from baseline at 24 and 36 months on the Midface Volume Deficit Scale (MFVDS). Secondary endpoints included improvement from baseline to 24 and 36 months on the Physician- and Subject-rated Global Aesthetic Improvement Scales (PGAIS and SGAIS, respectively). Results: The primary endpoint was met in 100% of the subjects, and the improvement in MFVDS score from baseline was significant at both 24 and 36 months (P<0.0001). PGAIS scores were rated as at least improved in 100% of subjects at 24 months and in 95% at 36 months. Similarly, 91 % of participants at 24 months and 95% at 36 months reported enhanced appearance as measured by SGAIS. No additional adverse events were reported over the extension study. Conclusion: PMMA-collagen gel is a safe, effective, and durable treatment for restoring mid-face volume.

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.

Given differences in buttock versus thigh cellulite, collagenase clostridium histolyticum‐aaes (CCH‐aaes) injection technique may impact treatment effects at these sites.

Radiofrequency and HIFEM have been used as standalone modalities in body contouring. The novel device allows their synchronous emission simultaneously in a single applicator.

Background: Radiofrequency-based and high-intensity focused electromagnetic (HIFEM)-based devices have proved effective and safe for abdominal body shaping. Radiofrequency is known to reduce adipose tissue, whereas HIFEM treatment is effective for muscle definition. The authors investigated the efficacy of a novel device delivering synchronized radiofrequency and HIFEM treatment simultaneously for abdominal toning and fat reduction. Methods: Seventy-two patients were enrolled and randomly divided into active (n = 48; age, 45.5 ± 13.0 years) and sham groups (n = 24; age, 44.6 ± 12.3 years). Both groups received three treatments on the abdomen once a week. The intensity in the active group was set to maximum tolerable level; in the sham group, the intensities were set to 5 percent. Ultrasound images were taken before treatment and at 1, 3, and 6 months after treatment to examine changes in subcutaneous fat and rectus abdominis muscle thickness. Digital photographs were taken, and satisfaction and therapy comfort were assessed. Results: Ultrasound images of the active group at 1 month showed significant (p < 0.05) reduction in adipose tissue thickness by 20.5 percent (4.8 ± 2.6 mm), whereas rectus abdominis muscle thickness increased by 21.5 percent (2.0 ± 0.8 mm). Results at 3 months improved to 28.3 percent (7.6 ± 3.7 mm) and 24.2 percent (2.3 ± 0.9 mm), respectively. Improvements were maintained at 6 months after treatment in the active group, whereas the sham group showed no significant changes. Treatments were found to be comfortable. The active group showed higher satisfaction with outcomes. Conclusion: Active treatment utilizing simultaneous application of radiofrequency and HIFEM therapy resulted in a significant increase in rectus abdominis thickness and subcutaneous fat reduction, exceeding previously published results for separate HIFEM and radiofrequency treatments. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Abstract Background Collagenase Clostridium histolyticum (CCH-aaes; QWO [Endo Aesthetics, Malvern, PA]) is an injectable, enzyme-based treatment indicated for the treatment of moderate to severe cellulite on the buttocks of adult women. The minimally invasive nature of the treatment makes it an attractive option for targeted disruption of the fibrous septae which give rise to the dimples characteristic of cellulite in buttocks and thighs. Objectives The article provides an overview of cellulite treatment with CCH-aaes, including patient identification and education, treatment planning, CCH-aaes dilution, injection technique, safety, and early experience with mitigation of adverse events, including bruising. Methods As part of a continuing medical education (CME; xMedica, Alpharetta, GA) event on developments in cellulite treatment, a panel of experts developed a course and roundtable, which included lectures on cellulite physiology, new developments in the field of cellulite treatment, demonstrations of injection technique for CCH-aaes, and a review of considerations for the use of CCH-aaes in real-world clinical practice. Results The practical guidance presented here is based upon real-world experience with CCH-aaes. The discussion includes strategies based on early experience for how to obtain the best results as well as suggestions on how to mitigate bruising. Conclusions CCH-aaes has been a welcome addition to the armamentarium for the treatment of cellulite. With knowledge of proper patient evaluation and injection technique, thorough patient education, diligent photography, and developing research on bruising mitigation, CCH-aaes shows great promise as an effective and safe modality for the management of cellulite. Level of Evidence: 5

Objective:The HIFEM procedure demonstrates positive outcomes on abdomen and buttock. This multi-center study aims to investigate its effect on adipose tissue and muscle mass located in upper arms and calves. Materials and Methods:Twenty subjects (45.10 +/- 15.19 years, 24.44 +/- 3.22 kg/m(2)) who underwent a HIFEM procedure (4 sessions; 20 minutes per muscle group) on arms and calves were evaluated. Overall, 7 patients were treated over biceps and triceps, 4 patients over calves, and 9 patients underwent treatment of both upper arms and calves. The changes in adipose and muscle tissue of musculus biceps brachii, triceps brachii, and gastrocnemius were evaluated by using ultrasound. The results from a 1-month, 3-month, and 6-month follow-up were compared to the baseline. Digital photographs, weight measurements, satisfaction, and comfort questionnaires were assessed at baseline and follow-ups. Results: Ultrasound images revealed a significant (P<0.05) increase in the muscle mass of all studied muscles, with the most noticeable improvement in biceps brachii (+16.13% at 3 months). The fat deposits over arms and calves showed significant improvement (P<0.05), reaching -15.12% at 3 months. The results peaked at 3 months and were sustained up to 6 months with a slight but insignificant decline. Aesthetic enhancement of treated areas was documented while patients were highly satisfied. Conclusions: The achieved outcomes showed that the HIFEM procedure is effective for muscle toning and fat reduction in arms and calves. The results suggest that the use of the HIFEM procedure is not limited only to abdominal and buttock shaping but is also effective for toning of arms and calves.

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.

BACKGROUND:In 2018, the first device to use high-intensity focused electromagnetic (HIFEM) technology to non-invasively build muscle was brought to market. Even more recently, the first HIFEM and radiofrequency combination device designed to both build muscle and eliminate fat cells came into use (HIFEM+). In view of the increase in recently published original data pertaining to HIFEM, an advisory board recently convened to discuss the group's clinical experiences with this technology. AIM:Communicate an advisory group's recommendations for the current use of HIFEM+ technology for aesthetic indications. METHODS:An advisory board meeting to discuss challenges and opportunities for HIFEM devices in aesthetic medicine took place in November 2020, via remote conference. The expert advisory board consisted of a group of senior aesthetic physicians regularly treating patients with non-invasive body contouring devices. A narrative review of the literature and key recommendations from the meeting are presented herein. RESULTS:To date, the combined results of several clinical studies (including over 500 patients and 30 investigators) support that patients treated with HIFEM+ experience on average, 30% less fat, 25% more muscle, 19% reduction in abdominal separation and up to 5.9 cm reduction in waist circumference. Moreover, HIFEM+ induces a 30% increase in satellite cell content, which is similar to the 36% increase observed following twelve weeks of exercise. CONCLUSIONS:The advisory board unanimously agreed on several messages related to HIFEM technology, including that the pairing of HIFEM and radiofrequency (HIFEM+) enables a higher intensity of muscle stimulation and lipolysis, compared to HIFEM alone.

IntroductionThe COVID‐19 pandemic requires us all to re‐evaluate aesthetic practices to ensure optimal patient safety during elective procedures. Specifically, energy‐based devices and lasers require special consideration, as they may emit plume which has been shown to contain tissue debris and aerosolized biological materials. Prior studies have shown transmission of viruses and bacteria via plume (i.e., HIV and papillomavirus). The purpose of this study was to evaluate plume characteristics of the Er:YAG resurfacing laser (Sciton; Palo Alto, CA) and compare it to the Morpheus8 fractional radiofrequency device (InMode; Lake Forest, CA).MethodsFive patients who underwent aesthetic resurfacing and/or skin tightening of the face and neck were treated with the Er:YAG (Sciton Joule, Palo Alto, CA) and/or fractional radiofrequency (Morpheus8, Lake Forest, CA) between April 1 and May 11, 2020. Data collected included patient demographics, past medical history, treatment parameters, adverse events, particle counter data, as well as high magnification video equiptment. Patients were evaluated during treatment with a calibrated particle meter (PCE; Jupiter, FL). The particle meter was used at a consistent focal distance (6­12 inches) to sample the surrounding environment during treatment at 2.83 L/min to a counting efficiency of 50% at 0.3 µm and 100% at >0.45 µm. Recordings were obtained with and without a smoke evacuator.ResultsOf our cohort (n = 5), average age was 58 years old (STD ±7.2). Average Fitzpatrick type was between 2 and 3. Two patients received Er:YAG fractional resurfacing in addition to fractional radiofrequency during the same treatment session. Two patients had fractional radiofrequency only, and one patient had laser treatment with the Er:YAG only. There were no adverse events recorded. The particle counter demonstrated ambient baseline particles/second (pps) at 8 (STD ±6). During fractional radiofrequency treatment at 1‐mm depth, the mean recording was 8 pps (STD ±8). At the more superficial depth of 0.5 mm, recordings showed 10 pps (STD ±6). The Er:YAG laser resurfacing laser had mean readings of 44 pps (STD ±11). When the particle sizes were broken down by size, the fractional radiofrequency device had overall smaller particle sizes with a count of 251 for 0.3 µm (STD ±147) compared with Er:YAG laser with a count of 112 for 0.3 µm (STD ±84). The fractional radiofrequency did not appear to emit particles >5 µm throughout the treatment, however, the Er:YAG laser consistently recorded majority of particles in the range of 5­10 µm. The addition of the smoke evacuator demonstrated a 50% reduction in both particles per second recorded as well as all particle sizes.ConclusionRe‐evaluation of the plume effect from aesthetic devices has become important during the COVID‐19 pandemic. Further studies are required to characterize viability of COVID‐19 viability and transmissibility in plume specimens. Based on this pilot study, we recommend that devices that generate little to no plume such as fractional radiofrequency devices be used in Phase I reopening of practice while devices that generate a visible plume such as Er:YAG laser resurfacing devices be avoided and only used with appropriate personal protective equipment in addition to a smoke evacuator in Phase IV reopening.

BACKGROUND In two phase 3 trials (NCT03168334, NCT03168321), participants with moderate-to-severe acne had significant symptom improvements after 12 weeks of treatment with tazarotene 0.045% lotion. Given the negative psychosocial effects of acne on patients, data from these studies were analyzed to evaluate quality of life in various subgroups. METHODS Mean changes from baseline to week 12 in Acne-Specific Quality of Life (Acne-QoL) domain and item scores were analyzed in the pooled intent-to-treat (ITT) population and in participants who were categorized as follows: Evaluator's Global Severity Score (EGSS) score=3 (“moderate”) or score=4 (“severe”) at baseline; Acne-QoL total score ≥60 (better quality of life) or <60 (worse quality of life), based on the median score at baseline. Exploratory analyses based on sex and race were also performed. RESULTS In the pooled ITT population (N=1614), Acne-QoL improvements were greater with tazarotene 0.045% lotion versus vehicle lotion, with significant differences in the acne symptoms domain, 3 acne symptom items, 2 self-perception items, 1 role-emotional item, and 1 role-social item (all P<0.05). Acne-QoL improvements with tazarotene 0.045% lotion were comparable between the EGSS subgroups. However, participants who self-reported worse quality of life at baseline (Acne-QoL total score <60) had notably greater improvements than those with better quality of life. Female and Black participants had greater Acne-QoL improvements than male and White participants. CONCLUSIONS Participants treated with tazarotene 0.045% lotion had significant quality-of-life improvements. Clinician-rated symptom severity appeared to have a smaller effect on Acne-QoL outcomes than participants’ own assessments of quality of life. J Drugs Dermatol. 2020;19(11): doi:10.36849/JDD.2020.5457.