Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Male and Female Acne: Phase 3 Analysis
October 2024 | Volume 23 | Issue 10 | 873 | Copyright © October 2024
Published online September 30, 2024
Edward (Ted) Lain MD MBAa, Neal Bhatia MDb, Leon Kircik MDc-e, Linda Stein Gold MDf, Julie C. Harper MDg, Christopher G. Bunick MD PhDh, Eric Guenin PharmD PhD MPHi, Hilary Baldwin MDj,k, Steven R. Feldman MD PhDl, James Q. Del Rosso DOm
aAustin Institute for Clinical Research, Austin, TX
bTherapeutics Clinical Research, San Diego, CA
cIcahn School of Medicine at Mount Sinai, New York, NY
dIndiana University School of Medicine, Indianapolis, IN
ePhysicians Skin Care, PLLC, DermResearch, PLLC; and Skin Sciences, PLLC, Louisville, KY
fHenry Ford Hospital, Detroit, MI
gDermatology & Skin Care Center of Birmingham, Birmingham, AL
hYale University Department of Dermatology and Program in Translational Biomedicine, New Haven, CT
iOrtho Dermatologics, Bridgewater, NJ
jThe Acne Treatment and Research Center, Brooklyn, NY
kRobert Wood Johnson University Hospital, New Brunswick, NJ
lWake Forest University School of Medicine, Winston-Salem, NC
mJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; Advanced Dermatology and Cosmetic Surgery, Maitland, FL; Touro University Nevada, Henderson, NV;
Abstract
Background: Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel (CAB) is the only fixed-dose triple-combination treatment approved for acne. This post hoc analysis assessed the impact of sex on efficacy and safety/tolerability of CAB.
Methods: In two multicenter, double-blind, phase 3 studies (NCT04214639 and NCT04214652), participants aged ≥9 years with moderate-to-severe acne were randomized (2:1) to 12 weeks of once-daily treatment with CAB or vehicle gel. Pooled data were analyzed by sex. Assessments included treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and a score of 0 [clear] or 1 [almost clear]), inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability.
Results: At week 12, treatment success rates were significantly greater with CAB versus vehicle irrespective of sex (females: 53.7% vs 23.0%; males: 43.1% vs 24.6%; P<0.05, both). CAB-treated female and male participants both experienced greater reductions from baseline versus vehicle in inflammatory (females: 77.7% vs 57.9%; males: 77.5% vs 57.1%; P<0.001, both) and noninflammatory lesions (females: 72.5% vs 45.6%; males: 72.3% vs 49.6%; P<0.001, both). Acne-QoL improvements from baseline to week 12 were significantly greater with CAB than vehicle. No significant differences in any efficacy measures between CAB-treated males and females were observed. Most TEAEs were of mild-to-moderate severity; no sex-based trends for safety/tolerability were observed.
Conclusions: CAB demonstrated comparable efficacy, quality-of-life improvements, and safety in female and male participants with moderate-to-severe acne. As the first fixed-dose, triple-combination topical formulation, CAB represents an important new treatment for acne.
J Drugs Dermatol. 2024;23(10):873-881. doi:10.36849/JDD.8484
INTRODUCTION
Acne is a chronic dermatologic condition affecting up to 50 million people in the United States annually.1 Although acne afflicts both males and females, skin physiology and acne presentation vary by sex. Males experience higher sebum production, less transepidermal water loss, and lower skin pH compared with females.2 Females are more likely to experience drier and more sensitive skin with age.3 While adolescent acne is more prevalent in males, females are more likely to experience persistent adult acne4-6 and acne flare-ups associated with monthly hormonal fluctuations.7 Together, these sex differences may necessitate distinct acne
