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
Recommended Citation
Kircik LH, Draelos ZD, Lain E, Harper JC, Baldwin H, Stein Gold LF, Gold M, Guenin E. 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. J Am Acad Dermatol 2025; 93:AB146.
Document Type
Conference Proceeding
Publication Date
9-1-2025
Publication Title
J Am Acad Dermatol
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
