Early and Sustained Effects of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel

Abstract

Introduction The combination of a topical antibiotic, retinoid, and benzoyl peroxide (BPO) is one of the most effective therapies for acne and has demonstrated greater efficacy versus monotherapy or dyads. However, it is unknown if triple-combinations impart rapid efficacy along with minimal tolerability issues, which may improve patient adherence. The only triple-combination acne topical, clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% (CAB) gel, has demonstrated efficacy and favorable tolerability in clinical trials. This pooled analysis assessed efficacy and safety of CAB versus vehicle following 4 and 12 weeks of treatment.

Methods Pooled data from 4 double-blind, 12-week trials (phase 2, NCT03170388 and NCT04892706; phase 3, NCT04214639 and NCT04214652) of participants aged ≥9 years (≥12 years in NCT04892706) with moderate to severe acne were used to assess change from baseline in inflammatory/noninflammatory lesions and treatment success (percentage of participants achieving ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and a score of 0 or 1 [clear/almost clear]). Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also evaluated.

Results Analyses were performed on data from 1115 participants randomized to CAB or vehicle (n=618 and n=497, respectively). At week 4, inflammatory lesions were reduced by >50% with CAB, with continued reductions of >75% at week 12, significantly greater than with vehicle (week 4, 53.8% vs 39.6%, respectively; week 12, 76.9% vs 52.9%; P<0.001 both). Similar trends were observed for noninflammatory lesions (P<0.001 both). Treatment success was achieved by 51.0% of CAB-treated participants vs 18.3% with vehicle (P<0.001) at week 12, with significant differences observed at week 4 (10.7% vs 4.2%; P<0.001). Application-site pain was the only treatment-related TEAE in ≥5% of CAB-treated participants. By week 4, transient increases in mean safety/tolerability scores for scaling, erythema, itching, stinging, and burning with CAB generally resolved to at/near baseline levels.

Conclusions In this pooled analysis, treatment with fixed-dose CAB led to rapid clinical improvements as early as week 4 with favorable tolerability. Though long-term topical acne treatment may be needed to achieve clear skin, the fast-acting efficacy of the only approved triple-combination product for acne—coupled with its once-daily dosing and tolerability—may improve patient satisfaction and treatment adherence.