1. Triple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis.
- Author
-
Kircik, Leon, Stein Gold, Linda, Gold, Michael, Weiss, Jonathan, Harper, Julie, Del Rosso, James, Bunick, Christopher, Bhatia, Neal, Tanghetti, Emil, Baldwin, Hilary, Draelos, Zoe, Callender, Valerie, Han, George, Gooderham, Melinda, Sadick, Neil, Lupo, Mary, Lain, Edward, Werschler, William, and Eichenfield, Lawrence
- Subjects
Acne ,Antibiotic ,Antimicrobial ,Clinical trial ,Combination treatment ,Retinoid ,Topical - Abstract
INTRODUCTION: A three-pronged approach to acne treatment combining an antibiotic, antimicrobial, and retinoid may be more efficacious than single/double treatments while potentially reducing antibiotic resistance. This study evaluated the efficacy and safety of the first fixed-dose, triple-combination topical acne product, clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) using pooled phase 3 data. METHODS: In two identical phase 3 (N = 183; N = 180), double-blind, 12-week studies, participants aged ≥ 9 years with moderate-to-severe acne were randomized 2:1 to receive once-daily CAB or vehicle gel. Endpoints included ≥ 2-grade reduction from baseline in Evaluators Global Severity Score and clear/almost clear skin (treatment success) and least-squares mean percent change from baseline in acne lesion counts. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated. RESULTS: At week 12, 50.0% of participants achieved treatment success with CAB versus 22.6% with vehicle gel (P 70% reductions in inflammatory and noninflammatory lesions at week 12 (77.9% and 73.0%, respectively), which were significantly greater than vehicle (57.9% and 48.2%; P
- Published
- 2024