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
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Keywords
acne, moderate, severe, topical, combination treatment, retinoid, antimicrobial, antibiotic
Abstract
Introduction: For most patients with acne, combination treatments targeting multiple pathogenic processes are recommended. 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. Analyses were conducted to compare the efficacy and safety of topical fixed-combination CAB gel vs 3 constituent dyad gels and commercially available adapalene 0.3%/BPO 2.5% gel across 4 clinical trials.
Methods: In pooled, post hoc analyses of two phase 2 (one head-to-head) and two phase 3 randomized, double-blind, 12-week clinical trials, CAB gel (n=618), 3 constituent dyad gels (n=146 or 150 each), commercially available adapalene 0.3%/BPO 2.5% gel (n=226), and vehicle (n=497) were compared in participants with moderate-to-severe acne. 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).
Results: 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.
Conclusions: CAB triple-combination gel demonstrated significantly greater efficacy vs component dyads and commercially available adapalene 0.3%/BPO 2.5% gel in this 4-trial pooled analysis. By week 12, CAB-treated participants had ~77% reduction in inflammatory lesion counts and half achieved clear/almost clear skin. To our knowledge, these analyses include data from the only double-blind, vehicle-controlled, head-to-head trial of topical combination acne treatments.
Funding: Ortho Dermatologics
References
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