43374 Impact of Age or Sex on Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel in Participants with Moderate-to-Severe Acne

Document Type

Conference Proceeding

Publication Date

9-19-2023

Publication Title

J Am Acad Dermatol

Abstract

IDP-126 polymeric mesh gel (clindamycin phosphate 1.2%/benzoyl peroxide [BPO] 3.1%/adapalene 0.15%) is the first triple-combination, fixed-dose acne topical in development. IDP-126 demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability in a phase 2[1] and two phase 3 studies [2,3] of moderate-to-severe acne. This post hoc analysis evaluated effect of age or sex on efficacy/safety of IDP-126 using pooled data from two phase 3 (N=183; N=180), double-blind, randomized, 12-week studies[2,3]. Participants aged ≥9 years with moderate-to-severe acne were randomized 2:1 to once-daily IDP-126 gel or vehicle gel. Data were analyzed by age (pediatric [9-17 years]: n=178; adult [≥18 years]: n=185) or sex (females: n=212; males: n=151). Endpoints included ≥2- grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success) and least-squares mean percent change from baseline in inflammatory/noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) were also assessed. At week 12, over half of pediatric and almost half of adult IDP-126-treated participants achieved treatment success (52.7% and 45.9%, respectively) versus one-fourth with vehicle (24.0% and 23.5%; P<0.01, both). Results by sex were similar (IDP-126 vs vehicle: females: 53.7% vs 23.0%; males: 43.1% vs 24.6%; P<0.05, both). IDP-126 provided >70% reductions in inflammatory/noninflammatory lesions in all subgroups versus vehicle (41%-63%; P≤0.001, all). Differences between sex or age groups were not statistically significant. Most TEAEs were of mild-moderate severity in all groups. Fixed-dose, triple-combination IDP-126 gel was efficacious and well tolerated, regardless of age or sex, with approximately half of participants with moderate-to-severe acne achieving clear/almost clear skin.

Volume

89

Issue

3

First Page

AB54

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