Kaminer et al., Multicenter pivotal study of vacuum-assisted precise tissue release for the treatment of cellulite – Dermatol Surg 2015;41:336–347

BACKGROUND: Cellulite refers to the dimpled appearance of skin occurring where the dermis is tethered by subcutaneous fibrous septa arranged perpendicularly to the skin surface.

OBJECTIVE: To demonstrate the safety and efficacy of a new system for vacuum-assisted precise tissue release for the treatment of cellulite.

MATERIALS AND METHODS: 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.

RESULTS: 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.

CONCLUSION: 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.

Kaminer et al., A multicenter pivotal study to evaluate tissue stabilized-guided Subcision using the Cellfina device for the treatment of cellulite with 3-year follow up – Dermatol Surg 2017;0:1–9

BACKGROUND: 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 subcision system (TS-GS system) has demonstrated significant reduction in the appearance of cellulite after treatment.

OBJECTIVE: The objective of this extended follow-up period was to assess the effectiveness of TS-GS out to 3 years after initial treatment.

PATIENTS AND METHODS: 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.

RESULTS: 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.

CONCLUSION: These data further demonstrate the safety and efficacy of this treatment with no reduction in treatment benefits out to 3 years.

Baspeyras et al., Restoring jawline contour with calcium hydroxylapatite: a prospective, observational study – J Cosmet Dermatol. 2017;1–6

BACKGROUND and AIM: Jawline reshaping by replacing volume has become an indispensable component of modern facial rejuvenation. The aim of this study was to evaluate calcium hydroxylapatite (CaHA) for the treatment of an aging jawline in a routine setting.

METHODS: Five investigators enrolled 35 subjects requesting jawline rejuvenation with CaHA. Injections were performed according to investigators usual practice. Baseline and post-treatment scores were evaluated using Merz Aesthetics Scales®. Follow-up visits took place at Day 30 (Day 60 for those with touch-up at Day 30), 180, and 360. Physician and patient satisfaction, aesthetic impact of treatment, and adverse events were recorded.

RESULTS: Improvements in jawline contour compared with baseline were statistically significant at each visit, with scores of 2.42 (moderate to severe sagging) at baseline, 1.02 (mild) at Day 30/60 (P≤.0001), 1.11 at Day 180 (P≤.0001), and 1.45 at Day 360 (P=.0015). Statistically significant improvements in marionette line scores were also observed. Investigators rated results as “improved” to “very much improved” in all subjects up to Day 180, and in 81% of subjects at Day 360. Satisfaction with treatment was very high. Adverse events were mostly mild and related to either the procedure or injection technique.

CONCLUSION: CaHA is a very effective agent for restoring jawline contour in routine practice and is associated with high levels of physician and patient satisfaction.

Prager et al., IncobotulinumtoxinA for aesthetic indications: a systematic review of prospective comparative trials – Dermatol Surg, 2017:959-966

BACKGROUND: IncobotulinumtoxinA is a botulinum toxin type A (BoNTA) indicated for temporary improvement in the appearance of upper facial lines with well-established efficacy and safety profiles. Whether incobotulinumtoxinA and other BoNTAs are equipotent is subject of debate.

OBJECTIVE: To compare the efficacy of incobotulinumtoxinA and other BoNTAs for aesthetic applications.

MATERIALS AND METHODS: PubMed and Embase were systematically searched for prospective clinical trials comparing incobotulinumtoxinA with onabotulinumtoxinA, abobotulinumtoxinA, or placebo for aesthetic applications.

RESULTS: Fifteen articles met the selection criteria. Two studies found that incobotulinumtoxinA was noninferior or equivalent to onabotulinumtoxinA for the treatment of glabellar frown lines (GFLs). Eight studies found no difference in efficacy between incobotulinumtoxinA and other BoNTAs. One study suggested differences in response rates at certain time points between incobotulinumtoxinA and onabotulinumtoxinA for GFLs, and one suggested differences for dynamic horizontal forehead lines but not for GFLs or lateral periorbital lines, but both had study design issues limiting the ability to draw conclusions. Finally, 3 placebo-controlled studies demonstrated the efficacy of incobotulinumtoxinA for treating GFLs and upper facial lines.

CONCLUSION: The weight of the evidence from comparative clinical trials indicates that incobotulinumtoxinA, onabotulinumtoxinA, and abobotulinumtoxinA have similar efficacy for aesthetic applications.

Pavicic et al., IncobotulinumtoxinA use in aesthetic indications in daily practice: a European multicentre, noninternventional, retrospective study – Clin Cos and Invest Derm, 2015;8:135-142

PURPOSE: To characterise utilization patterns and treatment satisfaction with incobotulinumtoxinA for aesthetic indications and assess adherence to the Summary of Product Characteristics.

PATIENTS AND METHODS: Data were collected retrospectively from physicians in Germany, France, and the UK regarding patients (n=638) treated with incobotulinumtoxinA for aesthetic indications. Data on indication, treatment interval, dose injected, physician and patient satisfaction, and adverse drug reactions were recorded according to routine daily practice.

RESULTS: Most patients (76.0%) received incobotulinumtoxinA for glabellar frown lines (GFL) and were given doses of #20 U. The majority of treatment intervals were 5 months or longer. Overall, 64.1% of patients were treated for off-label indications, sometimes in combination with treatment for GFL. The most frequently treated off-label indications were horizontal forehead lines (38.6%) and/or crow’s feet (CF; 31.7%); for CF, .95% of injected doses were #24 U. In Germany, a smaller proportion of patients were given incobotulinumtoxinA treatment for CF (27.6%), compared with France (40.4%) and the UK (33.2%), although country-specific differences were less prominent when treatment cycle data for CF were examined. Treatment satisfaction among physicians and patients (overall, and for GFL specifically) was very high, with excellent tolerability and only one mild adverse drug reaction reported.

CONCLUSION: In daily practice, incobotulinumtoxinA is mainly used for GFL; however, its use for CF and horizontal forehead lines (often in combination with GFL) is relatively common. Treatment satisfaction across aesthetic indications is high, and incobotulinumtoxinA is well tolerated, with time intervals of 5 months or longer between injections in the majority of cases. When considering factors such as dose and treatment interval, adherence to the Summary of Product Characteristics when treating GFL in daily practice is good. These results support previous reports that incobotulinumtoxinA is an effective treatment for GFL, with an excellent safety profile. Furthermore, incobotulinumtoxinA may display efficacy and tolerability in other indications.

Prager et al., Mid-face volumization with hyaluronic acid: injection technique and safety aspects from a controlled, randomized, double-blind clinical study – J Drugs Dermatol, 2017;16(4):351-357

BACKGROUND: Injection of hyaluronic acid (HA) volumizing fillers in the malar area is intended for rejuvenation of the mid-face. The choice of products, depth, and technique of injection depends on the desired level of volume enhancement and practitioners’ preferences.

OBJECTIVE: To describe a volumizing injection technique in the scope of a controlled, randomized, double-blind, single-center, split-face clinical study.

MATERIALS & METHODS: A total of 45 subjects with bilateral symmetrical moderate to severe volume loss in the malar area received a single 2 mL injection of CPM®-26 (Cohesive Polydensified Matrix®) on one side and VYC-20 (VYCROSS) on the contralateral side of the face. The same injection technique was applied for both sides of the face. Use of anesthetics, overcorrection, and touch-ups were not permitted. The investigator completed a product satisfaction questionnaire. Adverse events (AE) and injection-site reactions (ISRs) were reported during the study.

RESULTS: The products were placed at the epiperiosteal depth in 88.9% (n=40), at the subdermal depth in 8.9% (n=4) and at both levels in 2.2% (n=1) of subjects. Fanning technique using cannulae was applied in most cases (97.8%, n=44). Results of the investigator satisfaction questionnaire allowed to characterize CPM-26 in comparison to other volumizing gels. Both study products were generally well tolerated. Local reactions were transient and of mild to moderate intensity, with the most frequent ones being redness, pain, and swelling.

CONCLUSION: Adequate injection technique in volumizing treatments is essential to create a natural aesthetic rejuvenation while respecting the safety aspect of the procedures. A 22G blunt cannula used with CPM-26 was preferred due to an easier and a more homogenous distribution of the product. The investigator also appreciated CPM-26 for its ease of injection, positioning, lifting, and volumizing capacity.

Kerscher et al., Effectiveness evaluation of two volumizing hyaluronic acid dermal fillers in a controlled, randomized, double-blind, split-face clinical study – Clin Cos and Invest Derm, 2017;10:239-247

BACKGROUND: Enhancement of the midface can be achieved with volumizing hyaluronic acid (HA) fillers.

OBJECTIVE: The objective of this study was to compare the safety and effectiveness of Cohesive Polydensified Matrix® 26 mg/mL HA gel (CPM-26) and Vycross® 20 mg/ml HA gel (VYC-20) in a controlled, randomized, evaluator-blind, split-face clinical study.

PATIENTS AND METHODS: Subjects with moderate-to-severe malar volume loss on the Merz Aesthetics Scale (MAS) received CPM-26 on one side and VYC-20 on the contralateral side of the face. Effectiveness assessments were performed by blinded evaluators including photographic and live MAS ratings and live Global Aesthetic Improvement Scale (GAIS) ratings. Calculations of anatomical volume variations at month 3 (M3), month 6 (M6), month 12 (M12) and month 18 (M18) were also performed.

RESULTS: Non-inferiority of CPM-26 versus VYC-20 was demonstrated at M3 (primary endpoint) based on MAS. GAIS rating showed that significantly more subjects had better improvement with CPM-26 than with VYC-20 at month 1, M3, M12 and M18 (p=0.0032, p=0.0074, p=0.0384 and p=0.0110, respectively). Standardized evaluation of volume variations from baseline to M3, M12 and M18 showed that CPM-26 created more volume augmentation at all time points, and the difference was significant at M3.

CONCLUSION: CPM-26 was non-inferior to VYC-20 based on MAS ratings at M3 and demonstrated a favorable safety and effectiveness profile for midfacial volume enhancement with results lasting up to M18.