Long-Term Efficacy and Tolerability of Clindamycin Phosphate 1.2%/Adapalene0.15%/Benzoyl Peroxide 3.1% Gel for Acne in Participants With Fitzpatrick Skin Phototypes IV-VI: Pooled Results From Two 6-Month Studies

Vollständiger Abstract

Worum geht es in dieser Arbeit?

Introduction Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel—the only approved triple-combination acne topical—was efficacious and well tolerated in 12-week clinical trials and in 24-week studies. Acne presentation and sequelae vary by skin type, requiring long-term management strategies to account for differences in skin pigmentation. This post hoc analysis assessed long-term efficacy and tolerability of acne treatment with CAB gel in participants with Fitzpatrick skin phototypes IV-VI. Methods Data were pooled from 2 identical, postmarketing, 24-week, single-center, open-label studies of once-daily CAB gel in 50 participants ≥12 years with moderate to severe acne (Investigator’s Global Assessment [IGA] score=3 or 4). Endpoints included changes from baseline in IGA score and inflammatory/noninflammatory lesions at week 24. Scarring (assessed using the Goodman Qualitative Scar Scale), skin appearance (dryness, postinflammatory hyperpigmentation [PIH], postinflammatory erythema [PIE]), tolerability (itching, burning, redness, swelling), and adverse events (AEs) were evaluated. Results Of 24 participants with Fitzpatrick skin types IV-VI, 22 completed the studies. Participants were a mean age of 26.6 years and 86.4% were female. At week 24, 73% of participants achieved treatment success (≥2-grade reduction from baseline in IGA score and clear/almost clear skin), with reductions in inflammatory and noninflammatory lesions of 90% and 66%, respectively. PIH, PIE, and scarring improved from baseline by 71%, 87%, and 32%, respectively. No participants reported tolerability issues at week 24 and all had skin dryness scores of 0 (none). One participant experienced an AE (bronchitis), which was deemed unrelated to study product. Conclusions In participants with darker skin phototypes, 6 months of once-daily CAB gel use led to 73% treatment success and inflammatory lesion reductions of 90%. These improvements are higher than those seen at week 12 in the pivotal trials and support the long-term use of CAB gel in patients with darker skin phototypes.