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Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: A Randomized Phase II Study of the First Triple-Combination Drug.

Henry Ford Hospital, 6530 Farmington Rd, Ste 101, West Bloomfield, Detroit, MI, 48322, USA. LSTEIN1@hfhs.org. The Acne Treatment and Research Center, Brooklyn, NY, USA. Robert Wood Johnson University Hospital, New Brunswick, NJ, USA. Indiana University School of Medicine, Indianapolis, IN, USA. Physicians Skin Care, PLLC, Louisville, KY, USA. Icahn School of Medicine at Mount Sinai, New York, NY, USA. Georgia Dermatology Partners, Snellville, GA, USA. Gwinnett Clinical Research Center, Inc., Snellville, GA, USA. Eastern Virginia Medical School, Norfolk, VA, USA. Virginia Clinical Research, Inc., Norfolk, VA, USA. Callender Dermatology and Cosmetic Center, Glenn Dale, MD, USA. Howard University College of Medicine, Washington, DC, USA. Austin Institute for Clinical Research, Austin, TX, USA. Tennessee Clinical Research Center, Nashville, TN, USA. University of Miami Miller School of Medicine, Miami, FL, USA. Dermatology Consulting Services, PLLC, High Point, NC, USA. Weill Cornell Medical College, New York, NY, USA. Sadick Dermatology, New York, NY, USA. Bausch Health US, LLC, Petaluma, CA, USA. Center for Dermatology and Laser Surgery, Sacramento, CA, USA.

American journal of clinical dermatology. 2022;(1):93-104
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Abstract

BACKGROUND A three-pronged approach to acne treatment-combining an antibiotic, antibacterial, and retinoid-could provide greater efficacy and tolerability than single or dyad treatments, while potentially improving patient compliance and reducing antibiotic resistance. OBJECTIVES We aimed to evaluate the efficacy and safety of triple-combination, fixed-dose topical clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) gel for the treatment of acne. METHODS In a phase II, double-blind, multicenter, randomized, 12-week study, eligible participants aged ≥ 9 years with moderate-to-severe acne were equally randomized to once-daily IDP-126, vehicle, or one of three component dyad gels: BPO/adapalene; clindamycin phosphate/BPO; or clindamycin phosphate/adapalene. Coprimary endpoints were treatment success at week 12 (participants achieving a ≥ 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin) and least-squares mean absolute changes from baseline in inflammatory and noninflammatory lesion counts to week 12. Treatment-emergent adverse events and cutaneous safety/tolerability were also assessed. RESULTS A total of 741 participants were enrolled. At week 12, 52.5% of participants achieved treatment success with IDP-126 vs vehicle (8.1%) and dyads (range 27.8-30.5%; P ≤ 0.001, all). IDP-126 also provided significantly greater absolute reductions in inflammatory (29.9) and noninflammatory (35.5) lesions compared with vehicle or dyads (range inflammatory, 19.6-26.8; noninflammatory, 21.8-30.0; P < 0.05, all), corresponding to > 70% reductions with IDP-126. IDP-126 was well tolerated, with most treatment-emergent adverse events of mild-to-moderate severity. CONCLUSIONS Once-daily treatment with the novel fixed-dose triple-combination clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15% gel demonstrated superior efficacy to vehicle and all three dyad component gels, and was well tolerated over 12 weeks in pediatric, adolescent, and adult participants with moderate-to-severe acne. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov identifier NCT03170388 (registered 31 May, 2017).

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