Triple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis

• Published in: Dermatology and therapy Vol. 14; no. 5; pp. 1211 - 1227
• Main Authors: Kircik, Leon H., Stein Gold, Linda, Gold, Michael, Weiss, Jonathan S., Harper, Julie C., Del Rosso, James Q., Bunick, Christopher G., Bhatia, Neal, Tanghetti, Emil A., Eichenfield, Lawrence F., Baldwin, Hilary, Draelos, Zoe D., Callender, Valerie D., Han, George, Gooderham, Melinda J., Sadick, Neil, Lupo, Mary P., Lain, Edward (Ted), Werschler, William Philip
• Format: Journal Article
• Language: English
• Published: Cheshire Springer Healthcare 01-05-2024; Springer; Adis, Springer Healthcare
• Subjects: Acne; Analysis; Antibiotic; Antimicrobial; Benzoyl peroxide; Care and treatment; Clinical trial; Combination treatment; Composition; Dermatology; Diagnosis; Drug resistance in microorganisms; Health aspects; Internal Medicine; Medicine; Medicine & Public Health; NCT NCT; NCT04214639; NCT04214652; Oral and Maxillofacial Surgery; Original Research; Phosphates; Plastic Surgery; Prevention; Quality of Life Research; Retinoid; United States; Antimicrobial; Antibiotic; Combination treatment; Acne; Retinoid; Clinical trial; Topical
• ISSN: 2193-8210; 2190-9172
• DOI: 10.1007/s13555-024-01155-7

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 Evaluator’s 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
 < 0.001). CAB resulted in > 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
 < 0.001, both). Most TEAEs were of mild-moderate severity, and < 3% of CAB-treated participants discontinued study/treatment because of AEs. Transient increases from baseline in scaling, erythema, itching, burning, and stinging were observed with CAB, but resolved back to or near baseline values by week 12.
Conclusions
The innovative fixed-dose, triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel was efficacious and well tolerated in children, adolescents, and adults with moderate-to-severe acne. Half of participants achieved clear/almost clear skin by 12 weeks, rates not previously seen in clinical studies of other topical acne products.
Trial Registration
ClinicalTrials.gov identifier NCT04214639 and NCT04214652.