Early and Sustained Acne Lesion Reductions With Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel

Document Type

Article

Publication Date

3-1-2024

Publication Title

Journal of drugs in dermatology

Abstract

BACKGROUND: A once-daily, three-pronged approach using an antibiotic, antibacterial, and retinoid may provide faster acne improvement versus monotherapy or dual-combination products. This post hoc analysis compared threshold acne lesion reductions with clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel—the first FDA-approved triple-combination topical acne product—to its dyads and vehicle.

METHODS: Phase 2 (N=741; NCT03170388) and phase 3 (N=183; N=180; NCT04214639; NCT04214652), double-blind, 12-week studies randomized participants aged ≥ 9 years with moderate-to-severe acne to once-daily CAB or vehicle gel; the phase 2 study included three additional dyad gel arms. The pooled percentage of participants achieving ≥ 33%, ≥ 50%, and ≥ 75% reduction in inflammatory and noninflammatory acne lesions was evaluated.

RESULTS: As early as week 4 in the phase 2 study, ≥ 33% reduction in inflammatory lesions occurred in a significantly greater percentage of CAB gel-treated participants (82.7%) than with the 3 dyads and vehicle (61.1-69.8%; P< 0.05, all). These early reductions were sustained throughout the study, with significantly (P< 0.05) more CAB-treated participants achieving ≥ 50% reduction in inflammatory lesions versus dyads and vehicle from weeks 4-12. By week 12, CAB led to substantial reductions of ≥ 75% in significantly more participants than dyads and vehicle (65.8% vs 49.9-51.2% and 21.6%; P< 0.05, all). Similar trends were observed for noninflammatory lesions in the phase 2 study and for inflammatory and noninflammatory lesions in the phase 3 studies.

CONCLUSIONS: Lesion count reductions were significantly greater with CAB versus its dyads and vehicle gel as early as week 4, with substantial reductions observed after 12 weeks of treatment. This faster-acting and sustained efficacy of CAB gel—coupled with its optimized formulation, once-daily dosing, and tolerability—may positively impact treatment adherence.

Medical Subject Headings

Humans; Acne Vulgaris; Adapalene, Benzoyl Peroxide Drug Combination; Anti-Bacterial Agents; Clindamycin; Child

PubMed ID

38443130

Volume

23

Issue

3

First Page

125

Last Page

131

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