Efficacy and Safety of a New Resilient Hyaluronic Acid Filler in the Correction of Moderate-to-Severe Dynamic Perioral Rhytides: A 52-Week Prospective, Multicenter, Controlled, Randomized, Evaluator-Blinded Study.

BACKGROUND: The perioral region is highly mobile and subject to multifactorial changes during aging. Resilient Hyaluronic Acid Redensity (RHAR), an RHA filler, was developed with the aim of optimizing outcomes in dynamic facial areas. OBJECTIVE: This randomized, blinded, multicenter clinical study aimed to demonstrate superiority of RHAR over no-treatment control for correction of moderate-to-severe dynamic perioral rhytides. MATERIALS AND METHODS: Blinded live evaluator assessments of efficacy included improvement in perioral rhytides severity using a proprietary scale (Perioral Rhytids Severity Rating Scale [PR-SRS]) and the Global Aesthetic Improvement Scale. Subjects self-assessed their results with FACE-Q, a validated patient-reported outcome measure, and satisfaction scales. Safety was monitored throughout the study based on common treatment responses (CTRs) and adverse events (AEs). RESULTS: The primary efficacy end point was achieved, with the treatment group showing statistically significant superiority over the control group at Week 8 (80.7% vs 7.8% responder rate by PR-SRS, p < .0001). Most patients (66%) were still responders at Week 52 (study completion). Most AEs were CTRs after perioral injection of a dermal filler, and none was a clinically significant treatment-related AE. CONCLUSION: Resilient Hyaluronic Acid Redensity is effective and safe for the correction of dynamic perioral rhytides in all Fitzpatrick phototypes, with marked durability.

Safety and Effectiveness of a Novel Hyaluronic Acid Gel for Lip Augmentation.

OBJECTIVE: To compare the safety and efficacy of a novel hyaluronic acid injectable gel with 0.3% lidocaine (test device) with that of a commercially available injectable hyaluronic acid gel with 0.3% lidocaine (comparator) for lip augmentation. METHODS: Eligible patients (n = 158) with an overall score of very thin (n = 0) or thin (n = 1) on a 5-point Lip Fullness Grading Scale (LFGS) participated in the double-blind, randomized, multicenter study. Efficacy was assessed periodically over 6 months on a per protocol (PP) population (definitive) and a modified intent-to-treat (mITT) population (supportive). RESULTS: In the PP population, the mean change from baseline (day 56) in LFGS score was 1.52 for the test device and 1.53 for the comparator. This 56-day change was the primary efficacy endpoint. The 95% confidence interval (CI) limits for the mean difference in scores (test device minus comparator) were -0.33 and 0.31. In the mITT population, the corresponding 95% CI limits were -0.26 and 0.31. In both populations, the lower limits, -0.33 and -0.26, were higher than the prespecified -0.50, indicating that the test device was non-inferior to comparator. The adverse event profile was similar between the treatment groups. Ninety-three percent of patients treated with test device considered themselves improved, much improved, or very much improved at day 168 compared to 82% of those treated with comparator. The corresponding investigator improvement ratings were 100% and 76%, respectively. CONCLUSION: For lip augmentation, the efficacy and safety of the test device is non-inferior to comparator. J Drugs Dermatol. 2022;21(1):13-20 doi:10.36849/JDD.6548.

A Multicenter Study to Evaluate Subject Satisfaction With Two Treatments of AbobotulinumtoxinA a Year in the Glabellar Lines.

BACKGROUND: Real-world re-treatment intervals for botulinum toxins vary, but most subjects receive treatment less frequently than the manufacturer-recommended minimum intervals. In subjects receiving treatment with AbobotulinumtoxinA (ABO) less frequently, high levels of satisfaction and psychosocial improvements in well-being, self-confidence, and quality of life are observed. OBJECTIVE: To evaluate subject satisfaction with a twice yearly re-treatment schedule. METHODS AND MATERIALS: This open-label, multicenter, interventional study evaluated subject satisfaction following injections of ABO 50 U in the glabellar lines at baseline and 6 months. The primary end point was subject satisfaction at 12 months. Secondary endpoints included subject satisfaction, FACE-Q scales, and glabellar line severity scale (GLSS). RESULTS: Ninety-five percent of the 120 subjects were "highly satisfied" or "satisfied" with their treatment outcomes at 12 months. FACE-Q total scores suggested that subjects were less bothered by glabellar lines and felt better about their facial appearance with each treatment versus baseline. Approximately half of subjects had ≥1-grade improvement from baseline in GLSS at 12 months. Median onset of effect was 2 days. CONCLUSION: The majority of subjects (95%) were satisfied with ABO treatment every 6 months; results were supported by high subject satisfaction, long duration, rapid onset, natural-looking results, and overall psychological wellness and safety.

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.

Aesthetic Office Disaster Preparedness and Response Plan.

The coronavirus pandemic (COVID-19) has served as a call-to-arms in preparing practices for the next disaster whether it is another infectious disease or a flood, hurricane, earthquake, a sustained power outage, or something else. A group of predominantly core aesthetic physicians discussed the various aspects of their office procedures that warrant consideration in a proactive approach to the next pandemic/disaster-related event. This guide does not set a standard of practice but contains recommendations that may avoid some of the "lessons learned" with the COVID-19 pandemic. In this paper, the board-certified core aesthetic physicians classified these recommendations into four generalized areas: Practice Management; Supplies and Inventory; Office Staffing Considerations and Protocols; and Patient Management Strategies. Proactive strategies are provided in each of these categories that, if implemented, may alleviate the processes involved with an efficient office closure and reopening process including, in the case of COVID-19, methods to reduce the risk of transmission to doctors, staff, and patients. These strategies also include being prepared for emergency-related notifications of employees and patients; the acquisition of necessary equipment and supplies such as personal protective equipment; and the maintenance and accessibility of essential data and contact information for patients, vendors, financial advisors, and other pertinent entities.J Drugs Dermatol. 2021;20(1):10-16. doi:10.36849/JDD.5803.

AbobotulinumtoxinA Treatment of Glabellar Lines Using a New Reconstitution and Injection Volume: Randomized, Placebo-Controlled Data.

BACKGROUND: Increasing the reconstitution and injection volumes of abobotulinumtoxinA (aboBoNT-A) could provide more options for aesthetic healthcare professionals. OBJECTIVE: To evaluate efficacy and safety of aboBoNT-A treatment of moderate-to-severe glabellar lines (GL) versus placebo, using a new reconstitution and injection volume. Methods & Materials: In this 6-month, Phase III, randomized, double-blind study, subjects 18-64 years were administered aboBoNT-A 50 U (N=224) or placebo (N=77), as five 0.1-mL-injections (10 U) in the glabellar region following reconstitution of a 300-U-vial in 3 mL. Assessments included time to onset of effect, investigator- (ILA) and subject- (SSA) assessed GL severity, subject satisfaction, aesthetic improvement and safety. The primary endpoint was composite 2-grade response at month 1 (a GL severity of none-or-mild at maximum frown and ≥2-grade improvement from baseline concurrently on both ILA and SSA). RESULTS: Median time to onset was 2 days, 34% of subjects reporting effect on day 1. At month 1, the composite 2-grade responder rate was 65.8% for aboBoNT-A versus 0% for placebo, P<0.001, 91–92% had none-or-mild GL severity, and 95–100% had a ≥1-grade GL severity improvement. A ≥1-grade improvement was sustained in 46-56% of aboBoNT-A-treated subjects up to 6 months (P<0.001 vs placebo). Aesthetic improvement and subject satisfaction were high throughout 6 months and aboBoNT-A treatment was well tolerated. CONCLUSION: Safety and efficacy of GL treatment using 0.1 mL (10 U) aboBoNT-A per injection site were demonstrated, with rapid onset and up to 6 months’ duration of effect. Severity improvement was accompanied by sustained aesthetic improvement and subject satisfaction. J Drugs Dermatol. 2021;20(9):988-995. doi:10.36849/JDD.6130.

The First of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines. METHODS: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as assessed by the investigator on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment of 20 U prabotulinumtoxinA (4 U/0.1 mL freeze-dried formulation injected into 5 target glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety was evaluated throughout the study. RESULTS: The 352 study patients received a median total dose of 60 U, that is, 3 treatments per year. Fifty-one patients (14.5%) experienced adverse events (AEs) assessed as possibly study drug related; 11.1% experienced study drug-related AEs after the initial treatment. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Six patients (1.7%) experienced study drug-related AEs of special interest: 3 eyelid ptosis (0.9%), 2 speech disorder (0.6%), and 1 blepharospasm (0.3%). Seven patients (2.0%) experienced serious AEs; none were study drug related. Of the 2393 samples tested, 2 patients (0.6%) tested positive for antibotulinum toxin antibodies at a single postbaseline visit. CONCLUSIONS: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was first established in this early phase II study based on a broad range of outcomes.

The Second of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines. METHODS: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as independently assessed by both investigator and patient on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment (IT) of 20 U prabotulinumtoxinA (4 U/0.1 mL final vacuum-dried formulation injected into 5 glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety outcomes were evaluated throughout the study. RESULTS: The 570 study patients received a median total dose of 60 U, that is, 3 treatments. Sixty-one patients (10.7%) experienced adverse events (AEs) assessed as possibly study drug related; 6.5% experienced study drug-related AEs after the IT. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Eight patients (1.4%) experienced study drug-related AEs of special interest: 5 experienced eyelid ptosis (0.9%), 3 eyebrow ptosis (0.5%), 1 blepharospasm (0.2%), and 1 blurred vision (0.2%). Seven patients (1.2%) experienced serious AEs, but none were study drug related. A total of 4060 serum samples were tested for antibotulinum toxin antibodies; no seroconversion was observed. CONCLUSIONS: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was confirmed in this second phase II study based on a broad range of outcomes.

DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2).

BACKGROUND: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A in clinical development. Phase 2 data have shown it offers a more prolonged duration of response than onabotulinumtoxinA. OBJECTIVE: To further evaluate the efficacy, duration of response, and safety of 40 U DAXI compared with placebo in the treatment of glabellar lines. METHODS: Two identical, multicenter, randomized, double-blind, placebo-controlled, phase 3 studies were performed (NCT03014622 and NCT03014635 on www.clinicaltrials.gov). Participants with moderate or severe glabellar lines were randomly assigned (2:1) to receive 40 U DAXI or placebo into the corrugator/procerus muscles. Glabellar line severity was assessed by investigators and participants for up to 36 weeks (≥24 weeks). RESULTS: Among 609 participants enrolled (405 DAXI, 204 placebo), 92% completed. DAXI was significantly more effective than placebo in reducing glabellar line severity and maintained none or mild glabellar line severity for a median of 24.0 weeks. It was also generally well tolerated-treatment-related adverse effects were most commonly headache (6.4% vs 2.0%) and injection site pain (3.7% vs 3.9%). LIMITATIONS: The study population was predominantly female and white and received only a single treatment. CONCLUSIONS: DAXI offers a prolonged duration of response for glabellar line reduction and is well tolerated.

Efficacy and Safety of Systemic Treatments for Skin and Joint Manifestations in Patients With Psoriasis.

Psoriasis is a chronic, systemic disease with features suggestive of autoimmune dysregulation. Patients with psoriasis vulgaris frequently experience systemic comorbidities, including cardiovascular and metabolic diseases, and approximately 30% develop psoriatic arthritis (PsA), which requires treatment. It is important that physicians and patients are aware of the breadth of treatment options available to treat the complete spectrum of psoriasis manifestations. This narrative review summarizes clinical information from approved systemic psoriasis therapies relevant to the treatment of PsA and related systemic pathologies. We include pivotal clinical trials of biologic therapies that are approved by the US Food and Drug Administration for psoriasis and PsA and additional studies identified from PubMed and congress abstract searches through August 21, 2019. We comment on the real-world effectiveness of traditional nonbiologic treatment options, including methotrexate, cyclosporine, acitretin, systemic corticosteroids, and nonsteroidal anti-inflammatory drugs and consider targeted synthetic and biologic disease-modifying antirheumatic drugs and their efficacy and safety in treating skin and joint manifestations. Finally, we discuss key considerations when managing patients with PsA as a comorbidity of psoriasis. The individual treatment needs of patients should be met while psoriasis and its systemic complications are managed. When addressing these needs, it is important to consider modern biologics and other systemic therapies. J Drugs Dermatol. 2020;19(3): doi:10.36849/JDD.2020.4690THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Hydrogen Peroxide Topical Solution, 45% for Common Warts: Phase 2 Efficacy and Safety Trial Results.

BACKGROUND: No FDA-approved prescription therapies are available for common warts. OBJECTIVE: We evaluated a proprietary hydrogen peroxide topical solution, 45% (w/w) (HP45) for treatment of common warts. METHODS: In the phase 2 randomized, double-blind, vehicle-controlled WART-203 trial (NCT03278028), eligible patients aged ≥8 years had 1–6 warts (1 target wart) on the trunk or extremities with a Physician’s Wart Assessment™ (PWA) grade ≥2 (range, 0 [clear] to 3 [wart 3–8 mm in diameter or length]). Patients self-administered HP45 or vehicle twice weekly for 8 weeks and were evaluated through 12 weeks posttreatment (week 20). Efficacy assessments included mean change in target wart PWA grade from baseline at week 8 (primary endpoint) and proportions of patients with target wart clearance. Safety assessments included treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs). RESULTS: A total of 157 patients completed 8 weeks of treatment (HP45, n=79; vehicle, n=78); 151 patients completed the 20-week posttreatment evaluation (HP45, n=75; vehicle, n=76). A significantly greater reduction in mean target wart PWA grade from baseline at week 8 was achieved with HP45 (−0.87) vs vehicle (−0.17; P<0.0001) and maintained at week 20 (−1.00 vs −0.39; P=0.0004). The proportion of patients with target wart clearance at week 8 was significantly greater with HP45 (25.3%) vs vehicle (2.6%; P<0.0001) and remained significantly greater at week 20 (37.3% vs 11.8%; P=0.0002). Forty-seven patients reported 76 TEAEs; most were mild or moderate in severity. Most LSRs were mild and resolved by week 20. In pediatric patients (HP45, n=13; vehicle, n=6), greater reductions in mean target wart PWA grade from baseline were observed with HP45 vs vehicle at weeks 8 (−1.0 vs 0) and 20 (−1.2 vs −0.5). CONCLUSION: These findings support the efficacy and safety of HP45 for the treatment of common warts in patients ≥8 years of age. J Drugs Dermatol. 2020;19(10):969-976. doi:10.36849/JDD.2020.5054.

Safety and Effectiveness of Microfocused Ultrasound for Treating Erythematotelangiectatic Rosacea

Background: Anecdotal reports indicate the use of microfocused ultrasound with visualization (MFU-V) improves facial redness. Objective: The purpose of this pilot study was to assess the safety and effectiveness of MFU-V for improving the signs and symptoms of erythematotelangiectatic rosacea. Methods & Materials: Healthy adults with a clinical diagnosis of erythematotelangiectatic rosacea were enrolled (N=91). Eligible subjects had baseline Clinician Erythema Assessment (CEA) scores ≥3 and Patient Self-Assessment (PSA) of erythema scores ≥2. Subjects were randomized to receive one or two low-density MFU-V treatments or one or two high-density MFU-V treatments. Subjects were evaluated at 90, 180, and 365 days after treatment. The primary effectiveness endpoint was treatment success, defined as a 1-point change in CEA scores at 90 days post-treatment. Results: Across groups, 75 to 91.3% of subjects achieved treatment success at 90 days post-treatment. Notable adverse events include bruising (44%), tenderness/soreness (43%), and redness (35%). Treatment results were sustained, lasting up to 1 year. Subject satisfaction was high based on self-assessment questionnaires. Conclusion: The results of this study demonstrated that a single, high-density MFU-V treatment may be effective for treating erythematotelangiectatic rosacea. Based on these results, a large, randomized controlled study of single, high-density MFU-V treatment for erythematotelangiectatic rosacea is warranted. J Drugs Dermatol. 2019;18(6):522-531.

Final Data from the Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR)

Perceptions of attractiveness can be negatively affected by submental fullness. Patients seeking to improve their submental contour have a variety of treatment options including surgical procedures, energy-based devices, and injectable treatment. The Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR) was designed to provide insights into the treatment of submental fat (SMF) in clinical practice. CONTOUR was a prospective observational study that enrolled 1029 adults at 91 sites in the United States and Canada. Patients were followed until treatment completion, discontinuation, or 1 year elapsed from enrollment without treatment. Final data from CONTOUR are reported here. Of the 676 patients who underwent treatment, 570 were treated with ATX-101 (deoxycholic acid injection), 77 with energy-based devices, 23 with surgical liposuction, 5 with laser liposuction, and 9 with other treatments. The majority of treated patients were facial aesthetic treatment naive. A markedly greater percentage of patients with mild or moderate SMF at baseline received treatment with ATX-101 or energy-based devices, whereas the majority of patients undergoing liposuction had severe or extreme SMF. Physicians most frequently cited a preference for a noninvasive/minimally invasive procedure as the reason for choosing either ATX-101 or energy-based devices. The majority of patients were at least partially satisfied with results, regardless of the chosen treatment. Data from CONTOUR indicate that cost is the most important factor in a patient's decision to undergo treatment, that choice of treatment method is most influenced by SMF severity and preference for nonsurgical versus surgical intervention, and that the availability of noninvasive/minimally invasive options has made SMF treatment an attractive first procedure for patients who have not undergone previous facial aesthetic treatments. ClinicalTrials.gov identifier: NCT02438813. J Drugs Dermatol. 2019;18(1):40-48.

Safety and efficacy of hydrogen peroxide topical solution, 40% (w/w), in patients with seborrheic keratoses: Results from 2 identical, randomized, double-blind, placebo-controlled, phase 3 studies (A-101-SEBK-301/302).

BACKGROUND: Approved topical treatments for seborrheic keratoses (SKs) are an unmet need. OBJECTIVE: To evaluate the safety and efficacy of 40% hydrogen peroxide topical solution (HP40) versus vehicle for the treatment of SKs (A-101-SEBK). METHODS: A total of 937 patients with 4 SKs each (≥1 lesion each on the face and on the trunk and/or an extremity) were randomized 1:1 to HP40 or vehicle. At each visit, SKs were graded using the Physician's Lesion Assessment (PLA) scale (0, clear; 1, nearly clear; 2, ≤1 mm thick; and 3, >1 mm thick). After 1 treatment, SKs with a PLA score higher than 0 were re-treated 3 weeks later. RESULTS: At day 106, significantly more patients treated with HP40 than with vehicle achieved a PLA score of 0 on all 4 SKs (study 1, 4% vs 0%; study 2, 8% vs 0% [both P < .01]) and on 3 of 4 SKs (study 1, 13% vs 0%; study 2, 23% vs 0% [both P < .0001]). A higher mean per-patient percentage of SKs were clear (study 1, 25% vs 2%; study 2, 34% vs 1%) and clear or nearly clear (study 1, 47% vs 10%; study 2, 54% vs 5%) with HP40 than with vehicle. Local skin reactions were largely mild and resolved by day 106. LIMITATIONS: The optimal number of treatment sessions was not evaluated. CONCLUSION: Application of HP40 was well tolerated and effective in the removal of SKs.

A Multicenter, Double-Blinded, Randomized, Split-Face Study of the Safety and Efficacy of a Novel Hyaluronic Acid Gel for the Correction of Nasolabial Folds.

BACKGROUND: Injectable hyaluronic acid is frequently used to correct volume loss in nasolabial folds. OBJECTIVE: To compare the safety and efficacy of a novel hyaluronic acid gel to a non-animal stabilized hyaluronic acid (Comparator) gel for the correction of nasolabial folds (NLF). METHODS: Qualified subjects had NLF with a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe). NLFs were treated with Test Product on one side of the face and Comparator on the other side of the face (facial side randomly assigned). Improvement from baseline was evaluated at weeks 1, 2, 4, 12, and 24 weeks. The primary study endpoint was the mean change in WSRS score from baseline to week 24. RESULTS: The mean changes in WSRS score from baseline were 1.02 ±0.689 for Test Product and 0.91±0.762 for Comparator. The mean difference in change from baseline in WSRS scoring (Comparator minus Test Product) at week 24 was -0.11 (-0.225-0.001, 95% confidence interval [CI]). The upper boundary (0.001) of the 95% CI was less than the prespecified non-inferiority limit of 0.50, indicating that the Test Product was non-inferior to the Comparator. No subject discontinued the study due to adverse events. CONCLUSION: The Test Product is safe and non-inferior to the Comparator for the correction of nasolabial folds. The Test Product was associated with less swelling, pain, and overall severity of treatment-emergent adverse events than the Comparator.

J Drugs Dermatol. 2018;17(1):66-73.

Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials.

BACKGROUND: ATX-101 (deoxycholic acid injection) is the only injectable drug approved for submental fat (SMF) reduction. In the phase 3 REFINE trials, adults with moderate or severe SMF who were dissatisfied with the appearance of their face/chin were eligible to receive up to 6 treatment sessions with ATX-101 (2 mg/cm2) or placebo. Primary and secondary endpoints, evaluated at 12 weeks after last treatment, significantly favored ATX-101 supporting its efficacy for reducing SMF and the psychological impact of SMF, and increasing satisfaction with the appearance of the face/chin. OBJECTIVES: To evaluate the efficacy and safety of ATX-101 by treatment session. METHODS: This post hoc analysis used pooled data from the REFINE trials to evaluate efficacy endpoints and adverse events following each treatment session to further characterize the ATX-101 treatment response and safety profile. RESULTS: In both treatment groups, mean injection volume declined over subsequent treatment sessions, though more markedly in the ATX-101 group. The majority of ATX-101-treated patients achieved a ≥1-grade improvement in SMF within 2 to 4 treatment sessions based on either clinician or patient assessment. Furthermore, 19.1% of ATX-101-treated patients (vs 3.9% of placebo-treated patients) received fewer than 6 treatment sessions owing to patient satisfaction with treatment or lack of sufficient SMF for further treatment. In both treatment groups, the incidence/severity of common injection-site adverse events declined over subsequent treatment sessions. CONCLUSIONS: Although up to 6 treatment sessions were permitted in the REFINE trials, most ATX-101-treated patients achieved an improvement in SMF within 2 to 4 treatment sessions. Level of Evidence: 3.

New Uses of AbobotulinumtoxinA in Aesthetics.

BotulinumtoxinA (BoNT-A) is now widely established for the main approved indication of reducing glabellar lines, and is also widely used off-label to improve the appearance of wrinkles and lines in other parts of the face. The number of aesthetic procedures continues to increase as the patient population becomes more diverse, in particular with increasing numbers of people of color and men. Further developments in treatment may continue to expand the audience for BoNT-A by making procedures more comfortable and by delivering a more natural, less static appearance. These may be achieved through use of combinations of BoNT-A with other aesthetic procedures, tailoring the dose of toxin to the patient's muscle mass or by using novel injection and application techniques. Beyond amelioration of facial lines, encouraging results have been seen with the use of BoNT-A to improve the appearance of hypertrophic and keloid scars and even to prevent them. Studies have been conducted with scars in various parts of the body and further research is ongoing. Dermatological and other medical uses for BoNT-A are also active areas of research. Injections of BoNT-A have been shown to reduce signs and symptoms of acne, rosacea, and psoriasis, to reduce neuromuscular pain, and to bring about significant improvements in a number of rare diseases that are caused or exacerbated by hyperhidrosis. This paper reviews these new uses for BoNT-A, looking at the rationale for their use and discussing the results of published case studies and clinical trials. These areas have shown great promise to date, but more and larger clinical studies will be required before these treatments become a clinical reality. To this end details are also provided of clinical trials currently listed in the main clinical trials database to highlight research areas of particular interest.

Assessment of a Novel Anti-Aging Hand Cream.

There are few creams that have been developed for the purpose of treating the aging hand, yet UV damage and secondary signs of aging on the hands make them one of the most obvious indicators of age outside the face. This study documents results of a 120 day trial using a novel cream preparation containing ingredients including Retinol, Alpha-Arbutin, Kojic Dipalmitate, Azaeleic Acid, Hexylresorcinol, Licorice Root, and other ingredients. Results were tabulated comparing physician and patient assessment scores using a comprehensive scoring assay, which showed significant improvements across eight parameters tested. This was statistically significant for physician ratings of texture, wrinkles and pigment at 120 days versus baseline (P < 0.001). Further research is needed, but the results appear to indicate the benefits of a targeted hand cream in improving the appearance of the aging hand.

Split-Face Comparison of an Advanced Non-Hydroquinone Lightening Solution to 4% Hydroquinone.

INTRODUCTION: Hyperpigmentation is a primary concern for many cosmetic patients because of its high rate of occurrence and significant impact on perceived age. While 4% hydroquinone has been the gold-standard of treatment, there is a growing interest in non-hydroquinone solutions, however, many of these newer solutions fail to deliver equivalent improvement. METHODS: This double-blind, randomized, split-face study compares the effects of a new OTC non-hydroquinone lightening product (JM) to an available 4% hydroquinone lightening solution (OB) on the appearance of hyperpigmentation, texture, and ne lines and wrinkles. Comparisons were determined by both physician assessment and subject self-assessment at baseline, 4, 8, and 12 weeks. RESULTS: Physician assessment showed statistically equivalent improvement on both sides of the face with the JM side showing equivalent or superior average improvement in all assessed categories. Subject self-assessment showed a significant preference for the JM product over the 4% hydroquinone and a substantially higher perception of overall improvement over 4% hydroquinone (P=0.058). DISCUSSION: Physician assessment showed equal or superior average improvement in all measured categories with no statistically significant difference between the two sides. Subject self-assessment, however, showed a significant and growing preference toward the investigated JM product over the course of the study. Overall, the results of this study show the JM product to be equivalent if not superior to 4% hydroquinone for results and patient satisfaction. J Drugs Dermatol. 2016;15(12):1571-1577.

A Firming Neck Cream Containing N-Acetyl Glucosamine Significantly Improves Signs of Aging on the Challenging Neck and Décolletage.

BACKGROUND: Noninvasive antiaging neck and décolletage treatments are highly sought after by aging patients. A topical cosmetic antiaging cream was formulated with skin matrix building and smoothing ingredients to help reverse visible signs of aging on the neck and décolletage, including laxity, crepiness, deep lines, and hyperpigmentation. OBJECTIVE: A clinical study was conducted to evaluate the efficacy and safety of the antiaging neck/décolletage cream over a 16-week treatment period. METHOD: Caucasian women with moderate texture (including wrinkles, fine lines, laxity, and/or crepiness) on the neck and hyperpigmentation on the décolletage used the test cream for 16 weeks. At weeks 0, 8, 12 and 16, the dermatologist investigator graded neck texture, décolletage texture and décolletage pigmentation using a 0-5 scale, and irritation/tolerability using a 0-4 scale. Subjects were photographed and provided self-assessment of their aging parameters as well as product tolerability. Chromameter measurements were collected in triplicate on the chest at weeks 0, 8, and 16 to quantitatively and objectively assess pigmentation. RESULTS: Forty-two women completed the study. All dermatologist-graded aging parameters were significantly improved at each time point, P<0.001. Chromameter measurements demonstrated significant improvements in brightness (L*) and redness (a*), P<0.05. Self-assessed aging parameters were significantly improved on the décolletage and neck, P<0.05. Digital photography demonstrated obvious antiaging effects including improved texture of neck and décolletage areas, reduced appearance of lines and wrinkles, reduced mottled hyperpigmentation, and a more youthful, firm appearance. The test cream was well-tolerated with no significant changes in irritation parameters throughout the study. CONCLUSION: The antiaging neck/décolletage cream delivered significant firming and smoothing effects with reduced appearance of hyperpigmentation and can be considered an effective topical homecare treatment option for patients seeking rejuvenation of this challenging area