Clinical Assessment of 2 Licensed AbobotulinumtoxinA Injection Volumes for the Treatment of Glabellar Lines.

BACKGROUND: Two licensed reconstitution volumes may be used to achieve the recommended abobotulinumtoxinA (ABO) dose for glabellar line correction. OBJECTIVE: Comparison of efficacy, safety, and subject satisfaction concerning treatment of moderate to severe glabellar lines with 2 different ABO reconstitution volumes. MATERIALS AND METHODS: Phase IV, prospective, randomized, multicenter, subject- and evaluator-blinded study: 60 subjects received 1 ABO (50 units) treatment, administered as a 1.5- or 2.5-mL reconstitution. Primary objective was Day 30 improvements (≥1-point) in glabellar line severity. Onset of effect, duration, subject satisfaction, and treatment-related adverse events (AEs) were assessed. RESULTS: At Day 30, 90.0% and 86.7% of subjects achieved ≥1-point improvements with 1.5- and 2.5-mL reconstitutions, respectively. Median time to onset of effect was 48 hours after treatment. At 24 hours, 26.7% achieved ≥1-point improvements with the 2.5-mL reconstitution versus 6.7% with the 1.5-mL reconstitution. Maximum response was at Day 14, and >40% maintained efficacy through Day 120 in each group. High subject satisfaction was sustained throughout observation. Most AEs were mild. No serious AEs were reported. CONCLUSION: Both ABO reconstitutions were well tolerated and effective in correcting glabellar lines with no significant differences concerning efficacy or duration of effect. No serious AEs were reported.

Treatment Response With Once-Daily Topical Dapsone Gel, 7.5% for Acne Vulgaris: Subgroup Analysis of Pooled Data from Two Randomized, Double-Blind Stu.

BACKGROUND: Acne vulgaris has varying physical and psychological effects in men and women of different ages, races, and ethnicities.

OBJECTIVE: This analysis assessed the relationship of age, sex, and race to treatment response with once-daily topical dapsone gel, 7.5%.

METHODS: We conducted a pooled subgroup analysis of 2 randomized, double-blind, vehicle-controlled clinical trials conducted in the US and Canada. The studies included patients with 20 to 50 inflammatory and 30 to 100 noninflammatory facial lesions, and a Global Acne Assessment Score (GAAS) of 3 (moderate). Pooled data (N=4340) were analyzed by age (12-17 and ≥18 years), sex, and race (Caucasian and non-Caucasian) for GAAS success (score of 0 [none] or 1 [minimal]) and mean percent change from baseline in inflammatory, noninflammatory, and total lesion counts. The impact of age and sex on treatment response was examined using multivariate analysis. Adverse events were analyzed by subgroups.

RESULTS: Treatment responses with dapsone gel, 7.5% were greater overall and for all subgroups versus vehicle. GAAS success rates and mean decrease in all lesion counts with dapsone gel, 7.5% were greater in older (aged ≥18 years) versus younger patients, and for females versus males. Treatment response with dapsone gel, 7.5% in racial subgroups was similar. Multivariate analysis showed statistical significance for age group and sex as predictors of GAAS success (P less than equal to .005) and reduction in lesion counts (P less than equal to .025). Adverse events were similar across subgroups.

CONCLUSIONS: Older age (≥18 years) and female sex were predictors of treatment response. These subgroups tended to have greater acne improvement in subgroup comparisons. Caucasian and non-Caucasian patients had similar responses. The safety profile of dapsone gel, 7.5% was similar across subgroups.

J Drugs Dermatol. 2017;16(6):591-598.

Safety of a novel gel formulation of clindamycin phosphate 1.2%-tretinoin 0.025%: results from a 52-week open-label study.

Acne affects as many as 50 million individuals in the United States. Topical therapy combining a retinoid and an antibiotic is recommended as a first-line therapeutic option for mild to moderately severe acne. Although treatment for extended durations may be required, little long-term safety data on these combination therapies are available. This report summarizes the long-term safety and tolerability of a novel combination product for the treatment of acne vulgaris in participants 12 years and older. The combination treatment is a gel formulation containing a crystalline suspension of clindamycin phosphate 1.2%-tretinoin 0.025% (CLIN/RA). Two cohorts participated in a long-term (up to 52 weeks), multicenter, open-label, safety evaluation of CLIN/RA. Treatment duration was 6 months for the first cohort (N = 442) and 12 months for the second cohort (N = 213). Overall, the CLIN/RA gel was well-tolerated; 92%, 91%, and 94% of participants reported no itching, burning, or stinging, respectively. The most frequent adverse events were acne (29/442; 7% [usually a flare]), sunburn (12/442; 3%), hypersensitivity (7/442; 2%), contact dermatitis (5/442; 1%), and application-site desquamation (3/442; 1%). These results confirm the safety of CLIN/RA gel for mild to moderately severe acne. The CLIN/RA gel fixed-dose combination provided minimal adverse events and a favorable safety profile for 2 agents with established efficacy for the treatment of acne vulgaris.