Clindamycin Phosphate 1.2%/Adapalene 0.15%/ Benzoyl Peroxide 3.1% for Acne: Results From A 6-Month Open-Label Study
May 2025 | Volume 24 | Issue 5 | 516 | Copyright © May 2025
Published online April 30, 2025
Zoe Diana Draelos MDa, Mahmoud Ghannoum PhDb,c, Linda Stein Gold MDd, Julie C. Harper MDe, Hilary Baldwin MDf,g, Eric Guenin PharmD PhD MPHh, Emil A. Tanghetti MDi
aDermatology Consulting Services, High Point, NC
bCase Western Reserve University, Cleveland, OH
cUniversity Hospitals Cleveland Medical Center, Cleveland, OH
dHenry Ford Hospital, Detroit, MI
eDermatology & Skin Care Center of Birmingham, Birmingham, AL
fThe Acne Treatment and Research Center, Brooklyn, NY
gRobert Wood Johnson University Hospital, New Brunswick, NJ
hOrtho Dermatologics,* Bridgewater, NJ
iCenter for Dermatology and Laser Surgery, Sacramento, CA
*Ortho Dermatologics is a division of Bausch Health US, LLC.
Abstract
Background: Treatment of acne may require many months of treatment before maximal benefits are observed, and acne sequelae (eg, scarring, dyspigmentation) can persist long after lesion resolution. In 12-week clinical trials, triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel (CAB) demonstrated efficacy and tolerability in the treatment of moderate to severe acne. This study assessed CAB long-term efficacy/tolerability and reductions in acne scarring/dyspigmentation.
Methods: This 24-week, single-center, open-label study assessed once-daily CAB in participants (N=25) aged ≥12 years with moderate acne (Investigator’s Global Assessment [IGA] score=3). Endpoints included change from baseline in IGA score, inflammatory/noninflammatory lesions, skin appearance (dryness, postinflammatory hyperpigmentation [PIH], and postinflammatory erythema [PIE]), and scarring. Tolerability parameters (itching, burning, redness, swelling) and adverse events were assessed. At baseline and week 24, participants’ foreheads were swabbed to assess Cutibacterium acnes.
Results: At week 24, 68% of participants achieved treatment success (≥2-grade IGA score reduction from baseline and clear/almost clear skin), and significant inflammatory/noninflammatory lesion reductions from baseline were observed (89%; 70%; P<0.001, both). Decreases from baseline in investigator- and participant-assessed PIH (77%; 82%) and PIE (84%; 88%) and investigator-assessed scarring severity (33%) were statistically significant (P≤0.001, all). There were no significant increases in skin dryness or any tolerability parameter, and no adverse events occurred. C. acnes assessment indicated no development of antibiotic resistance with long-term CAB treatment.
Conclusions: With 24 weeks of once-daily use, CAB was efficacious, well-tolerated, and significantly improved acne-related scarring and dyspigmentation. These results support the long-term use of CAB in the topical treatment of acne.
Citation: Draelos ZD, Ghannoum M, Stein Gold L, et al. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% for acne: results from a six-month open-label study. J Drugs Dermatol. 2025;24(5):516-523. doi:10.36849/JDD.9018
INTRODUCTION
The management of acne vulgaris is difficult owing to the chronic nature of the disease and frequent relapses.1 As such, treatment duration can last for months or years.1,2 Therapeutics that maintain efficacy, safety, and tolerability with prolonged treatment are needed for adequate disease management.3,4 Although acne is characterized by inflammatory and noninflammatory lesions, scarring and dyspigmentation are common, with prevalence estimates of scarring ranging from 43% to 90.8%.5-7 Acne sequelae can persist long after primary acne lesions have resolved and may be more distressing to patients than active acne lesions,5,8,9 underscoring the need for therapies that reduce scarring and dyspigmentation in addition to treating lesions.
Combination therapy targeting multiple acne pathogenic factors is recommended for topical acne treatment.4 Retinoids regulate epithelial proliferation, antibiotics and benzoyl peroxide (BPO) reduce viability of Cutibacterium acnes, and all 3 active ingredients have anti-inflammatory properties.10-12 BPO has the additional benefit of preventing antibiotic resistance that may develop with prolonged antibiotic treatment.13 Fixed
