Early and Sustained Acne Lesion Reductions With Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel
March 2024 | Volume 23 | Issue 3 | 125 | Copyright © March 2024
Published online February 22, 2024
Julie C. Harper MDa, Leon H. Kircik MDb, Michael Gold MDc, Adelaide A. Hebert MDd, Jeffrey L. Sugarman MD PhDe, Lawrence Green MDf, Linda Stein Gold MDg, Hilary Baldwin MDh, Eric Guenin PharmD PhD MPHi, James Q. DelRosso DOj
aDermatology & Skin Care Center of Birmingham, Birmingham, AL
bIcahn School of Medicine at Mount Sinai, New York, NY; Indiana University School of Medicine, Indianapolis, IN;
Physicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, KY
cTennessee Clinical Research Center, Nashville, TN
dUTHealth McGovern Medical School Houston, Houston, TX
eUniversity of California, San Francisco, CA
fGeorge Washington University School of Medicine, Washington, DC
gHenry Ford Hospital, Detroit, MI
hThe Acne Treatment and Research Center, Brooklyn, NY
iOrtho Dermatologics, Bridgewater, NJ*
jJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; Advanced Dermatology and Cosmetic Surgery, Maitland, FL; Touro University Nevada, Henderson, NV
*Ortho Dermatologics is a division of Bausch Health US, LLC
Abstract
Background: A once-daily, three-pronged approach using an antibiotic, antibacterial, and retinoid may provide faster acne improvement versus monotherapy or dual-combination products. This post hoc analysis compared threshold acne lesion reductions with clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel -- the first FDA-approved triple-combination topical acne product -- to its dyads and vehicle.
Methods: Phase 2 (N=741; NCT03170388) and phase 3 (N=183; N=180; NCT04214639; NCT04214652), double-blind, 12-week studies randomized participants aged ≥9 years with moderate-to-severe acne to once-daily CAB or vehicle gel; the phase 2 study included three additional dyad gel arms. The pooled percentage of participants achieving =>33%, =>50%, and =>75% reduction in inflammatory and noninflammatory acne lesions was evaluated.
Results: As early as week 4 in the phase 2 study, =>33% reduction in inflammatory lesions occurred in a significantly greater percentage of CAB gel-treated participants (82.7%) than with the 3 dyads and vehicle (61.1-69.8%; P<0.05, all). These early reductions were sustained throughout the study, with significantly (P<0.05) more CAB-treated participants achieving ≥50% reduction in inflammatory lesions versus dyads and vehicle from weeks 4-12. By week 12, CAB led to substantial reductions of =>75% in significantly more participants than dyads and vehicle (65.8% vs 49.9-51.2% and 21.6%; P<0.05, all). Similar trends were observed for noninflammatory lesions in the phase 2 study and for inflammatory and noninflammatory lesions in the phase 3 studies.
Conclusions: Lesion count reductions were significantly greater with CAB versus its dyads and vehicle gel as early as week 4, with substantial reductions observed after 12 weeks of treatment. This faster-acting and sustained efficacy of CAB gel -- coupled with its optimized formulation, once-daily dosing, and tolerability -- may positively impact treatment adherence.
J Drugs Dermatol. 2024;23(3):125-131 doi:10.36849/JDD.7907
INTRODUCTION
Acne vulgaris is a common dermatologic condition that can have a profound psychosocial impact on patients' quality of life.1,2 While several oral and topical drugs are currently available for acne therapy, treatment can be challenging owing to the chronic nature of acne and its multifactorial underlying pathology.1 Treatment is further hindered by low adherence typical of acne therapies,3-6 with multiple factors contributing to nonadherence including side effects, difficulty incorporating the treatment routine, and treatment cost.7 Additionally, many acne medication regimens currently available may take weeks or months to produce an improvement discernible by patients. This lag between treatment initiation and acne improvement noticeable to patients can further reduce adherence, potentially contributing to treatment failure.1,8
