Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines.

BACKGROUND: RelabotulinumtoxinA (RelaBoNT-A, Galderma, Uppsala, Sweden) is an innovative, ready-to-use liquid botulinum toxin A, produced using PEARLTM manufacturing technology that yields a potent, complex-free formulation. OBJECTIVES: The READY-1 study examined efficacy and safety outcomes following a single RelaBoNT-A treatment for glabellar line correction. METHODS: Adults with moderate-to-severe glabellar lines received RelaBoNT-A (50 U) or placebo in a 3:1 randomized, 6-month, Phase 3, multicenter, double-blind study. Primary endpoints (examined at Month 1, maximum frown) comprised the composite ≥2-grade response, defined as ≥2-grades' improvement from baseline on concurrent investigator (GL-ILA) and subject (GL-SLA) severity scales (US endpoint), and the investigator-reported responder rate for subjects scored as 0 (none) or 1 (mild) (GL-ILA scale only; EU endpoint). Subject satisfaction and treatment-emergent adverse events (TEAEs) were reported. RESULTS: Overall, 297 adults were randomized and treated. Month 1 composite ≥2-grade responder rate was 82.9% (RelaBoNT-A, N=199) versus 0% (placebo, N=67; p<0.001). Month 1 investigator-reported none-or-mild responder rate was 96.3% (RelaBoNT-A) versus 4.5% (placebo; p<0.001). GL-ILA scores (none-or-mild; ≥1-grade improvement) remained higher with RelaBoNT-A (23.6%; 58.1%) versus placebo (1.5%; 10.4%) through Month 6 (p<0.001). In the Kaplan-Meier analysis, 75% still showed GL-ILA and GL-SLA improvements from baseline at 169 days (end-of-study). Subjects reported onset of effect from Day 1 (39%) and satisfaction with natural-looking results (96.8%; Month 1). RelaBoNT-A-related TEAEs were low (3.6%) and typically mild. CONCLUSIONS: A single RelaBoNT-A treatment was effective and demonstrated a favorable safety profile. RelaBoNT-A provided significant improvements in glabellar line severity, high satisfaction, rapid onset, and enduring effectiveness throughout the 6-month study period.

DMT310, a novel once-weekly topical treatment for patients with moderate-to-severe acne vulgaris: Results of a phase 2b randomized, double-blind, placebo-controlled trial.

BACKGROUND: Poor patient adherence with antiacne medications is a common clinical challenge. DMT310, a natural, topical product with a once-weekly application schedule, may alleviate this obstacle. OBJECTIVE: Evaluate the safety, tolerability, and efficacy of DMT310 in treating moderate-to-severe acne. METHODS: This 12-week, randomized, double-blind, placebo-controlled, multicenter clinical trial enrolled participants 12 years and older with moderate-to-severe acne. RESULTS: The intent-to-treat population included a total of 181 participants (DMT310, N = 91; placebo, N = 90). Participants who received DMT310 vs participants treated with placebo demonstrated a statistically significant greater reduction in the number of inflammatory and noninflammatory lesions at all time points: inflammatory lesion counts at week 12 (-15.64 vs -10.84, P < .001); noninflammatory lesion counts at week 12 (-18.26 vs -12.41, P < .001). DMT310-treated participants also had higher rates of Investigator's Global Assessment treatment success than participants in the placebo group at all time points: Investigator's Global Assessment at week 12 (44.40% vs 17.78%; P < .001). No serious treatment related adverse events occurred. CONCLUSIONS: DMT310 once-weekly topical treatment significantly reduced both inflammatory and noninflammatory lesions and yielded a greater proportion of Investigator's Global Assessment treatment success at all time points in participants with moderate-to-severe acne.

Efficacy of pulsed dye laser combined with fractional CO2 laser in the treatment of pediatric burn scars.

OBJECTIVE: The present study aimed to investigate the efficacy and safety of pulsed dye laser (PDL) combined with fractional CO2 laser in the treatment of burn scars in pediatric patients. METHODS: The present retrospective study enrolled 60 pediatric patients with burn scars from July 2017 to June 2021. In the 4-month treatment period, all patients received PDL treatment every 1 month and received fractional CO2 laser treatment every 3 months. The Patient and Observer Scar Assessment Scale (POSAS) was used to evaluate the scar condition before the treatment as well as 6 months after the whole treatment. The satisfaction of the patient's parents was collected and recorded 6 months after the treatment. Complications were recorded during the treatment period and at follow-up visits. RESULTS: Among all patients, 38 (63.33%) cases were scald-induced scars and 22 (36.67%) cases were burn-induced scars. The mean diameter of the scar area was 107.53 ± 2.92 cm2 . For the measurement of the patient part of POSAS, all indices of pain, itching, color, stiffness, thickness, and irregularity, as well as the total scores were remarkably lower after 6 months of the treatment compared with the baseline (p < 0.05). For the observer part of POSAS, the indices of vascularization, pigmentation, thickness, relief, pliability, and surface area, as well as the total scores were markedly decreased after treatment (p < 0.05). The total satisfactory rate was 96.67% (58/60). No severe complications nor scar aggravation was observed. CONCLUSION: The combination of PDL and fractional CO2 laser showed good efficacy in the treatment of pediatric patients with burn scars with no severe complications and can be recommended in clinical application.

Neurogenic Rosacea Treatment: A Literature Review.

Rosacea is a chronic skin disorder involving central facial erythema secondary to vascular instability and cutaneous inflammation. Rosacea is divided into different subtypes based on the morphology of the rash — erythematotelangiectatic, papulopustular, phymatous, and ocular rosacea. A less-known subtype called neurogenic rosacea has been proposed to categorize patients suffering from rosacea with erythematous flushing and burning sensation that is refractory to traditional treatment. There is minimal data on this subgroup of rosacea patients and its potential treatment options. This review aims to explore current medical literature to define characteristics of neurogenic rosacea and its management. We performed a systematic search of PubMed database and identified 6 articles meeting inclusion criteria with a total of 37 patients with suspected neurogenic rosacea. Combination treatments with topicals (eg, metronidazole, brimonidine), as well as oral medications including vascular (eg, beta blockers), psychiatric (eg, diazepam, duloxetine), neurologic (eg, pregabalin, sumatriptan), and antibiotic agents (eg, rifaximin), were often cited to have better outcomes, but this finding was highly variable between patients. There were isolated reports of effective management with onabotulinumtoxinA intradermal injections and endoscopic thoracic sympathectomy treatment. Current literature supports selecting agents aimed at treating the major symptom pattern (eg, erythema, telangiectasias, burning sensation). Neurogenic rosacea treatment: a literature review. Ivanic MG, Oulee A, Norden A, et al. J Drugs Dermatol. 2023;22(6):566-571. doi:10.36849/JDD.7181  .

Adverse Events of Non-Invasive Body Contouring: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database.

BACKGROUND: Multiple non-invasive modalities have become popular alternatives to surgical procedures for body contouring. OBJECTIVE: To analyze adverse events (AEs) associated with non-invasive body contouring devices reported through the Manufacturer and User Facility Device Experience (MAUDE) database. METHODS AND MATERIALS: The MAUDE database were queried for AEs associated with non-invasive body contouring devices between January 2011 and June 2021. An extensive list of keywords and brand and manufacturer names was used. RESULTS: A total of 1,325 reports with 1,590 AEs were identified among 6 modalities. More than 70% were reported in the past 5 years. Cryolipolysis made up 38.3% reports, which mostly pertained to paradoxical hyperplasia and hernias. Radiofrequency had the most reports (41.9%). Like laser devices, most of their reports described burns. Focused ultrasound was commonly associated with unintentional fat loss and surface irregularities. Focused electromagnetic field resulted in only 7 reports. CONCLUSION: The analysis of present study supports previous studies concerning common local symptoms caused by these devices, but it also reveals complications not reported in previous device studies. This study highlights the importance of proper technique and adherence to device guidelines. Practitioners should be knowledgeable of potential complications from each device to both prevent and manage them accordingly.

Efficacy and Safety of Letibotulinumtoxin A in the Treatment of Glabellar Lines: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study.

BACKGROUND: Letibotulinumtoxin A (Hugel, Inc., Chuncheon, Republic of Korea and CROMA Pharma, Leobendorf, Austria) is a newly manufactured neurotoxin derived from Clostridium botulinum strain CBFC26. OBJECTIVES: The aim of this study was to assess the efficacy and safety of letibotulinumtoxin A in reducing glabellar line severity (GLS) and to evaluate long-term safety and efficacy following repeated injections. METHODS: In this prospective, randomized, parallel-group, double-blind, multicentre, placebo-controlled Phase III clinical trial, 355 subjects with moderate to severe glabella frown lines received injections of 20 U of letibotulinumtoxin A or placebo. GLS, onset and duration of effect, time to retreatment, and adverse events were evaluated. Response to treatment was defined as a GLS score of 0 or 1 (assessed by the subject and the investigator) and an improvement at Week 4 of ≥2 points in GLS score relative to baseline. RESULTS: At 4 weeks, 78.6% of the active treatment subjects were responders based on the investigator's assessment and 68.8% based on the subject's assessment, resulting in a composite responder rate of 64.7% for the active treatment group, whereas the corresponding rate was 0.0% in the placebo group (P < 0.001). Subjects noted a substantial improvement in GL severity as early as Day 2, with the median time to onset of effect being 3 days. The mean [standard deviation] time until first retreatment for the letibotulinumtoxin A group was 127.26 [65.6] days. Letibotulinumtoxin A was well tolerated. CONCLUSIONS: Letibotulinumtoxin A demonstrates high efficacy and a convincing safety profile in the treatment of glabellar lines.

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.

Idiopathic guttate hypomelanosis: Presentation and Management.

Idiopathic guttate hypomelanosis (IGH) is a benign, typically asymptomatic, acquired leukoderma characteristically affecting mature individuals. Although the etiopathogenesis is unclear, chronic sun exposure and senile degeneration are important triggers. Researchers have been engaged in a continuous effort to unveil the gray areas encompassing different aspects of IGH pathogenesis. IGH is a clinical diagnosis; however, histopathology and dermoscopy may aid in quetionable cases. Patients often seek cosmetic treatment. There has been no standard therapy for this condition. Newer treatment modalities range from topical agents to procedure-based therapies and have enhanced the therapeutic armamentarium. Here we discuss the pathogenesis, presentation, and management of IGH.

Silicone sheets and new gels to treat hypertrophic scars and keloids: A short review.

Silicone dressings have been used to treat hypertrophic scars and keloids since 1983. This treatment modality is considered to be safe and efficacious, leading to a progressive improvement in scar color, size, erythema, pliability, pain, and itching. Its mechanism of action is due to the hydration of the skin corneal layer; and modulating the cell signaling between fibroblasts and keratinocytes, mediated by cytokines. Silicone dressings are considered first line treatments for hypertrophic scars and keloids. Silicone gels were developed later, in order to help treating those scars in areas such as the scalp or joints, where fixing the silicone sheets would be a more difficult task, or on the face, where a silicone dressing would be cosmetically undesirable to most. Similar to silicone sheets, silicone gels have also proved to help treating and preventing hypertrophic scars and keloids. A new silicone gel combined with hypochlorous acid has recently been developed to help in treating scars. Hypochlorous acid acts as a biocide and anti-inflammatory agent, therefore, it has also been used in post procedure, on recent traumatic scars or on nonepithelized skin. This manuscript reviews the use of silicone dressings, silicone gels, and combined gels to treat scars.

Development and Evaluation of an Atopic Dermatitis Care Plan for Providers.

Background/Significance of problem: Atopic Dermatitis (AD) is a common, chronic, inflammatory dermatosis and skin disease that follows a relapsing pattern and requires a dynamic stepwise approach to management. Providers feel comfortable treating chronic disease states with a guided tool or care plan in many chronic diseases. Care plans used in many chronic diseases such as asthma, diabetes, and COPD have demonstrated effectiveness in disease and healthcare provider management. There is an unmet need for a universal AD care plan for providers. Clinical question/project purpose: A universal AD care plan was developed to improve AD disease management and patient outcomes. Post-implementation of providers & perceptions was assessed for how the AD universal care plan affected their ability to provide patient education. Search of literature/best evidence: Review of literature includes: CINAHL, ProQuest Health, PubMed, Fusion, and UpToDate databases from 2008-2018.Search terms included: Atopic Dermatitis, Eczema, care plans, care plan use in chronic disease. Clinical appraisal of literature/best evidence: Analysis of the evidence supported the need for AD education, which then supported the need for a universal AD care plan for providers. Integration into practice: "Your Eczema Care Plan" was used by thirty-five healthcare providers to improve patient outcomes in a similar manner as other evidence-based care plans.Evaluation of evidenced-based practice: Post-implementation of providers & perceptions were evaluated on how the AD care plan tool affected their ability to provide patient education. Results suggest patient education, disease management, and QOL are all improved when utilizing "Your Eczema Action Plan." J Drugs Dermatol. 2020;19(10): 950-955. doi:10.36849/JDD.2020.5090.

A Supersaturated Oxygen Emulsion for Wound Care and Skin Rejuvenation.

Although oxygen is essential for proper wound healing, wounds are often hypoxic with diminished oxygen delivery to the healing tissue. Since oxygenation of the outer layers of skin is almost exclusively provided by the atmosphere, increasing the presence of external oxygen enhances the healing process. Hyperbaric oxygen therapy is beneficial for treating nonhealing wounds, such as diabetic ulcers, and has been used to speed post-treatment recovery following aesthetic procedures; however, it is not suitable for home use. Recently, perfluorocarbon emulsions have been developed that can absorb large amount of oxygen. Preparations containing 2% of these compounds can absorb up to seven-times more oxygen than water at 37°C. A topical perfluorocarbon emulsion consisting of perfluorodecalin, water, plant derived emulsifiers, and a preservative, has been developed for use in dermatology (Cutagenix™ & Cutavive™ Professional Skin Care Emulsion; Cutagenesis, Niwot, CO). Designed to be applied 2 to 4 times daily following skin rejuvenation procedures, this topical oxygen emulsion reduces the incidence of post-procedure complications. The application of a topical emulsion is well-suited for patient application to enhance recovery following energy-based aesthetic procedures. J Drugs Dermatol. 2020;19(3): doi:10.36849/JDD.2020.4728.

Treatment of Moderate to Severe Acne and Scars With a 650-Microsecond 1064-nm Laser and Isotretinoin.

BACKGROUND: Laser procedures for acne and acne scars have traditionally been postponed for at least 6 to 8 months after the end of systemic isotretinoin therapy. Lower dosages with more modern laser devices having unique energy parameters of high power in microsecond pulse durations have made it possible to administer laser therapy during or shortly after completion of isotretinoin therapy, thus reducing the risk of side effects of isotretinoin. METHODS: Patients with moderate to severe facial acne (n=46) and atrophic scars enrolled in a 6-month study. Genetic analysis of patients revealed the presence of polymorphisms of genes Col1A2, MMP3, ESR1, MMP1, and MMP7, which can lead to scar formation. Patients underwent low-dosage isotretinoin therapy (0.2-0.3 mg/kg/day) in combination with facial laser treatment using a 650-microsecond, 1064-nm Nd: YAG laser. Acne severity was graded using the Investigators Global Assessment (IGA) scale and quality of life was evaluated by the Dermatology Life Quality Index (DLQI). RESULTS: IGA parameters decreased from 1.8 ± 0.2 (mean ± SD) initially to 0.5 ± 0.4 at the end of the study, a 72.3% reduction which was significant (P<0.01). The DLQI index decreased from 10.1 ± 1.3 initially to 2.8 ± 1.2, a 72.3%, a significant reduction (P<0.01). Inflammatory elements resolved without scarring. Laser treatment was well tolerated and improvement in pre-existing scars was noticeable. CONCLUSIONS: The 650-microsecond, 1064-nm laser in combination with low-dose isotretinoin is safe and effective in patients with acne complicated by atrophic scars and genetically prone to post-acne scarring. J Drugs Dermatol. 2020;19(6):   doi:10.36849/JDD.2020.5108.

Tazarotene 0.045% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris in Adult Males

BACKGROUND: There has been an increasing interest in gender differences both in the pathogenesis and treatment of acne vulgaris (acne). However, while acne prevalence among adolescents is comparable across sexes, acne is much more common in adult women than in adult men which has been largely ignored. Acne is likely less common in adult men because of the declining rate of sebum secretion observed with increasing age, and yet it can be more severe than in adult women. In addition, adherence to topical medications is especially poor in adult men where tactile and sensory perceptions are low. The first lotion formulation of tazarotene was developed using polymeric emulsion technology to provide an important alternative option to treat these acne patients, especially those who may be sensitive to the irritant effects of other tazarotene formulations. OBJECTIVE: To evaluate the efficacy and safety of a new tazarotene 0.045% lotion formulation based on polymeric emulsion technology in treating adult male subjects with moderate or severe acne, in comparison with adolescent males treated with the same tazarotene 0.045% lotion. METHODS: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies in moderate-or-severe acne. Subjects (aged 10 and older, N=1614) were randomized (1:1) to receive tazarotene 0.045% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator's Global Severity Score [EGSS] and clear or almost clear). Quality of Life was assessed using the validated Acne-QoL scale. Safety, adverse events (AEs) were evaluated throughout; cutaneous tolerability (using a 4-point scale where 0=none and 3=severe) at each study visit. RESULTS: A total of 268 male subjects (85≥18 years old and 183<18 years old) were treated with tazarotene 0.045% lotion once-daily for 12 weeks. At week 12, percent reductions in inflammatory and noninflammatory lesions with tazarotene 0.045% lotion were 62.3% and 59.5% in the adult male population, compared with 49.4% (P=0.001) and 49.5% (P=0.016) in the adolescent male population. Treatment success was achieved by 33.0% of adult male subjects treated with tazarotene 0.045% lotion, compared with 21.6% in the adolescent male population (P=0.059). Quality of life (as assessed by Acne-QoL domain scores) was better in adolescent males at baseline. Improvements in QoL domain scores were similar to those seen in the overall study population, with greater absolute change in domain scores in the adult males. Improvement in acne symptom scores was significantly greater in adult males (P=0.029). Tazarotene 0.045% lotion was well-tolerated. The number of subjects reporting any AE in the adult male population was 11 (13.6%) compared with 39 (21.4%) in the adolescent male population. There was only one (1.2%) treatment-related AE (application site pain) reported in the adult males compared with 11 (6.0%) in the adolescent males, where the most common treatment-related AEs were application site pain (3.3%), dryness (1.1%), and erythema (1.1%). Mean scores for hyper- and hypopigmentation were very low at baseline in both groups with no appreciable change with treatment. CONCLUSIONS: Tazarotene 0.045% lotion provides greater efficacy and better tolerability in adult males (above 18 years old) than the adolescent male population with moderate-to-severe acne patients. J Drugs Dermatol. 2020;19(1):78-85. doi:10.36849/JDD.2020.3979

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.

CME/CE: ABOUT FACE: Navigating Neuromodulators and Injection Techniques for Optimal Results.

Interest in the cosmetic use of neuromodulators for facial rejuvenation is increasing among physicians, other practitioners, and patients alike, and an expanding array of formulations and reported applications might be helping to drive this trend. Safety, efficacy, and a high level of patient satisfaction can be achieved with all the available botulinum neurotoxin type A (BTXA) products. With any of the formulations, optimal results require knowledge of the individual product’s unique properties and dosing, along with an understanding of the patient’s goals, relevant anatomy, and proper injection technique. This educational activity reviews these topics on the basis of the published literature and expert opinion. A series of case narratives is also included that provides readers with information and insights for achieving success in clinical practice.J Drugs Dermatol. 2020;19(4 Suppl 2):s5-15.

ABOUT FACE: Navigating Neuromodulators and Injection Techniques for Optimal Results

Interest in the cosmetic use of neuromodulators for facial rejuvenation is increasing among physicians, other practitioners, and patients alike, and an expanding array of formulations and reported applications might be helping to drive this trend. Safety, efficacy, and a high level of patient satisfaction can be achieved with all the available botulinum neurotoxin type A (BTXA) products. With any of the formulations, optimal results require knowledge of the individual product's unique properties and dosing, along with an understanding of the patient's goals, relevant anatomy, and proper injection technique. This educational activity reviews these topics on the basis of the published literature and expert opinion. A series of case narratives is also included that provides readers with information and insights for achieving success in clinical practice. J Drugs Dermatol. 2020;19(4 Suppl 2):s5-15.

Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa.

BACKGROUND: Hidradenitis suppurativa is a painful, chronic inflammatory skin disease with few options for effective treatment. In a phase 2 trial, adalimumab, an antibody against tumor necrosis factor α, showed efficacy against hidradenitis suppurativa. METHODS: PIONEER I and II were similarly designed, phase 3 multicenter trials of adalimumab for hidradenitis suppurativa, with two double-blind, placebo-controlled periods. In period 1, patients were randomly assigned in a 1:1 ratio to 40 mg of adalimumab weekly or matching placebo for 12 weeks. In period 2, patients were reassigned to adalimumab at a weekly or every-other-week dose or to placebo for 24 weeks. The primary end point was a clinical response, defined as at least a 50% reduction from baseline in the abscess and inflammatory-nodule count, with no increase in abscess or draining-fistula counts, at week 12. RESULTS: We enrolled 307 patients in PIONEER I and 326 in PIONEER II. Clinical response rates at week 12 were significantly higher for the groups receiving adalimumab weekly than for the placebo groups: 41.8% versus 26.0% in PIONEER I (P=0.003) and 58.9% versus 27.6% in PIONEER II (P<0.001). Patients receiving adalimumab had significantly greater improvement than the placebo groups in rank-ordered secondary outcomes (lesions, pain, and the modified Sartorius score for disease severity) at week 12 in PIONEER II only. Serious adverse events in period 1 (excluding worsening of underlying disease) occurred in 1.3% of patients receiving adalimumab and 1.3% of those receiving placebo in PIONEER I and in 1.8% and 3.7% of patients, respectively, in PIONEER II. In period 2, the rates of serious adverse events were 4.6% or less in all the groups in both studies, with no significant between-group differences. CONCLUSIONS: Treatment with adalimumab (40 mg weekly), as compared with placebo, resulted in significantly higher clinical response rates in both trials at 12 weeks; rates of serious adverse events were similar in the study groups. (Funded by AbbVie; ClinicalTrials.gov numbers, NCT01468207 and NCT01468233 for PIONEER I and PIONEER II, respectively.).

Treatment of Atrophic Facial Acne Scars With Microneedling Followed by Polymethylmethacrylate-Collagen Gel Dermal Filler.

BACKGROUND: Microneedling and soft-tissue filler injections have been used independently to improve acne scarring. The effectiveness of a combined approach using microneedling followed by polymethylmethacrylate (PMMA)-collagen gel has not been carefully studied. OBJECTIVE: The goal of this study was to assess the effectiveness and safety of microneedling alone versus microneedling followed by injection of PMMA-collagen gel filler for correction of atrophic facial acne scars. METHODS: We conducted a multicenter, open-label, randomized, prospective study on subjects with distensible atrophic acne scars in the face to determine whether microneedling with PMMA-collagen gel is a superior acne scar treatment over microneedling alone. Forty-four subjects received 3 microneedling treatments over a 12-week period followed by randomization to treatments with PMMA-collagen gel (treatment group) or no further treatment (control group). RESULTS: At 24 weeks, the treatment group achieved a statistically significant improvement in acne scores over microneedling alone. The improvement continued at 36 weeks. At 24 weeks, the treatment group showed a strong trend in improvement on the Physician Global Aesthetic Improvement Scale compared with microneedling alone.

Dual wavelength treatment protocol with a picosecond laser for the reduction of facial wrinkles.

INTRODUCTION: The potential of a dual wavelength picosecond laser, as a new modality for treating photoaged skin, was investigated in this clinical study. MATERIAL AND METHODS: Subjects with bilateral mild-to-moderate facial wrinkling received four picosecond laser treatments, at 3-8 weeks apart, with a double-pass of both 532-nm and 1064-nm split-beam handpieces. Blinded evaluation of clinical photography, by two independent physicians, using the Fitzpatrick Elastosis Scale, was performed at 12 weeks after the fourth treatment. RESULTS: Twenty subjects (19 females; mean age 55 ± 7 years, Fitzpatrick Skin Types II-IV) were treated. Blinded evaluation demonstrated 75% (15/20) of the treated faces had improvement of at least one point. Investigator assessments showed a 100% improvement rate in the appearance of wrinkles and a mean elastosis score (ES) improvement of 2.1 ± 0.8 points. Subject satisfaction rate was 74%. Treatments were associated with no to mild discomfort with a mean score of 3.7 ± 1.9 on a scale of 0 (no pain) to 10. Common treatment responses included erythema (98%) and edema (7.5%) that generally resolved within several hours of treatment. CONCLUSION: In this study, picosecond laser treatments resulted in significant improvement in facial wrinkles. There were no complications with treatment and minimal downtime.

A randomized, controlled multicenter study evaluating focused ultrasound treatment for fat reduction in the flanks.

INTRODUCTION: Energy-based cosmetic devices offer an in-office treatment option, with minimal downtime, to non-invasively remove unwanted fat. We evaluated focused, pulsed ultrasound treatment to randomized flanks, compared to corresponding non-treated contralateral flanks. MATERIAL AND METHODS: Subjects were enrolled at three sites for a series of focused ultrasound treatments to a single flank, with the contralateral flank remaining untreated throughout the study. Success criteria included measureable fat thickness reduction on ultrasound imaging in the treated areas at 16 weeks after the final treatment session, and correct identification of the post-treatment photo and treated flank in at least 80% of evaluated images, as assessed by two blinded evaluators. RESULTS: The post-treatment flank photo and treated flank side were correctly identified in 82% and 93% of cases, respectively. All study subjects demonstrated significant fat reduction in their treated area, as measured by ultrasound and skin caliper. Subjects expressed a high satisfaction from treatment outcomes. There were no complications with treatment. CONCLUSION: A series of three ultrasound treatments resulted in significant fat reduction in treated flanks. Although treatment results are more modest than with liposuction, non-invasive ultrasound treatment may provide an attractive alternative for patients seeking an in-office, nonsurgical procedure for fat reduction.