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Open Access 09-05-2024 | Acne | Original Research

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

Authors: Leon H. Kircik, Linda Stein Gold, Michael Gold, Jonathan S. Weiss, Julie C. Harper, James Q. Del Rosso, Christopher G. Bunick, Neal Bhatia, Emil A. Tanghetti, Lawrence F. Eichenfield, Hilary Baldwin, Zoe D. Draelos, Valerie D. Callender, George Han, Melinda J. Gooderham, Neil Sadick, Mary P. Lupo, Edward (Ted) Lain, William Philip Werschler

Published in: Dermatology and Therapy | Issue 5/2024

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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 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.
Appendix
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Metadata
Title
Triple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis
Authors
Leon H. Kircik
Linda Stein Gold
Michael Gold
Jonathan S. Weiss
Julie C. Harper
James Q. Del Rosso
Christopher G. Bunick
Neal Bhatia
Emil A. Tanghetti
Lawrence F. Eichenfield
Hilary Baldwin
Zoe D. Draelos
Valerie D. Callender
George Han
Melinda J. Gooderham
Neil Sadick
Mary P. Lupo
Edward (Ted) Lain
William Philip Werschler
Publication date
09-05-2024
Publisher
Springer Healthcare
Published in
Dermatology and Therapy / Issue 5/2024
Print ISSN: 2193-8210
Electronic ISSN: 2190-9172
DOI
https://doi.org/10.1007/s13555-024-01155-7

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