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

Keywords

adapalene, benzoyl peroxide, clindamycin phosphate, acne vulgaris, adolescent, adult, child, conference abstract, controlled study, double blind procedure, drug efficacy, drug safety, drug therapy, drug tolerability, female, Global Severity Index, groups by age, human, least square analysis, male, meta analysis, phase 2 clinical trial (topic), phase 3 clinical trial (topic), post hoc analysis, randomized controlled trial (topic), skin

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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