Clindamycin Phosphate 1.2%/Adapalene 0.15%/ Benzoyl Peroxide 3.1% for Acne: Results From A 6-Month Open-Label Study

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.