63755 Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne: Efficacy and Safety Results from 4 Clinical Trials

Document Type

Conference Proceeding

Publication Date

9-1-2025

Publication Title

J Am Acad Dermatol

Keywords

adapalene, benzoyl peroxide, clindamycin, clindamycin phosphate, gel, acne, adult, child, conference abstract, controlled study, double blind procedure, drug therapy, female, Global Severity Index, human, major clinical study, male, multicenter study, phase 3 clinical trial, post hoc analysis, randomized controlled trial

Abstract

For most patients with acne, combination treatments targeting multiple pathogenic processes are recommended [1]. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% (CAB) gel is the only fixed-dose, triple-combination topical approved for acne. In pooled, post hoc analyses of two phase 2 (one head-to-head) and two phase 3 randomized, double-blind, 12-week studies, CAB gel (n=618), 3 constituent dyad gels (n=446), commercially available adapalene 0.3%/BPO 2.5% gel (n=226), and vehicle (n=497) were compared in participants with moderate-to-severe acne [2-4]. Assessments included treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin), least-squares mean percent change from baseline in inflammatory/noninflammatory lesion counts, and treatment-emergent adverse events (TEAEs). By week 12, >50% of CAB-treated participants achieved treatment success (51.0%), significantly more than approximately 33% treated with dyads or adapalene 0.3%/BPO 2.5% (range, 30.7%-35.8%) and <20% treated with vehicle (18.3%; P≤0.001, all). Inflammatory/noninflammatory lesion reductions at week 12 were significantly greater with CAB (76.9%/71.8%) versus dyads (range, 64.2%-69.2%/59.1%-61.1%; P<0.001, all), adapalene 0.3%/BPO 2.5% (73.0%/67.5%; P<0.05, both), and vehicle (52.9%/46.6%; P<0.001, both). Most TEAEs were mild-moderate in severity across all groups. TEAE rates for CAB and both adapalene/BPO gels were similar, indicating the addition of clindamycin did not worsen tolerability. CAB triple-combination gel demonstrated significantly greater efficacy vs component dyads and commercially available adapalene 0.3%/BPO 2.5% gel, with half of participants with moderate-severe acne achieving clear/almost clear skin by 12 weeks. To our knowledge, these analyses include data from the only double-blind, vehicle-controlled, head-to-head study of topical combination acne treatments [4].

Volume

93

First Page

AB146

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