Fixed‑Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Versus Adapalene 0.3%/Benzoyl Peroxide 2.5% Gels for Moderate‑to‑Severe Acne: Comparative Patient Journey

Abstract

Background: The American Academy of Dermatology recommends combination treatment for most patients with acne, but adding ingredients to a treatment regimen may increase the risk of adverse effects. Clindamycin phosphate 1.2%/adapalene (ADAP) 0.15%/benzoyl peroxide (BPO) 3.1% (CAB) gel is the only triple-combination fixed-dose topical formulation for acne. In clinical studies, CAB gel demonstrated superior efficacy to vehicle and component dyad gels, with good safety/tolerability.

Objectives: Document the treatment journey of clinical trial participants treated with either CAB gel or branded ADAP 0.3%/BPO 2.5% gel.

Methods: In a phase 2, double-blind, 12-week study (NCT04892706), participants aged ≥12 years with moderate to severe acne were randomized to once-daily CAB, branded ADAP 0.3%/BPO 2.5% (ADAP/BPO), or vehicle gel. Assessments included treatment success (≥2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear/almost clear skin), change from baseline in inflammatory (IL) and noninflammatory lesions (NIL), treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability. Descriptive data are summarized for 4 pairs of participants treated with CAB or ADAP/BPO; each pair was matched for baseline characteristics, acne severity, and lesion counts.

Results: Participant ages ranged from 13-21 years. At week 12, 3 of 4 CAB-treated and 1 of 4 ADAP/BPO-treated participants achieved treatment success. IL reductions from baseline with CAB and ADAP/BPO ranged from 63.1%-100% and 40.6%-81.8% respectively. NIL reductions ranged from 55.8%-98.0% with CAB and 32.4%-94.3% with ADAP/BPO. One participant reported a treatment-related TEAE (CAB-treated; moderate stinging; resolved) and no serious treatment-related TEAEs were reported. Transient increases in cutaneous safety/tolerability resolved to or near baseline by week 12.

Conclusions: In 4 matched participant pairs, treatment success and lesion reductions were greater overall with CAB gel than with ADAP/BPO gel, with similar safety/tolerability findings. In conjunction with results from the overall participant populations of CAB clinical trials, these data illustrate the potential of CAB gel as the only triple fixed-combination treatment option in the acne armamentarium.

Funding: Ortho Dermatologics