Long-Term Efficacy and Tolerability of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Acne: Pooled Results From Two 6-Month Studies
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Keywords
combination treatment, scarring, hyperpigmentation, long-term treatment, retinoid, antimicrobial, antibiotic
Abstract
Introduction: Given the chronic nature of acne, some patients may require long-term treatment lasting months to years. Even after lesion resolution, scarring and dyspigmentation may persist and can be more bothersome to patients than the acne itself. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel—the only approved triple-combination topical acne treatment—demonstrated superior efficacy to vehicle and its component dyads and favorable safety/tolerability in 12-week clinical trials. This pooled analysis assessed long-term efficacy and tolerability of CAB gel, as well as impacts on acne scarring and dyspigmentation.
Methods: Data were pooled from two identical, 24-week, single-center, open-label studies of once-daily CAB in 50 participants aged ≥12 years with moderate/severe acne (Investigator’s Global Assessment [IGA] score=3/4). Endpoints included changes from baseline in IGA score and inflammatory/noninflammatory lesions. Investigator-assessed skin appearance (dryness, postinflammatory hyperpigmentation [PIH], postinflammatory erythema [PIE]), and participant-assessed tolerability (itching, burning, redness, swelling) were evaluated on a 5-point scale (0 [none] to 4 [severe]). Scarring was evaluated using the Goodman Qualitative Scar Scale. Adverse events were assessed.
Results: Among 45 participants who completed the studies, the mean age was 22 years, 76% were female, and all Fitzpatrick skin types were represented. At week 24, treatment success (≥2-grade reduction in IGA score from baseline and clear/almost clear skin) was achieved by 67% of participants, inflammatory lesions were reduced by 88%, and noninflammatory lesions decreased by 68% (P<0.001 vs baseline, both). PIH, PIE, and scarring decreased by 71%, 77%, and 33% from baseline, respectively (P<0.001, all). Mean skin dryness scores were low (<0.15), and most participants (>70%) reported no tolerability issues across all time points. A total of 7 adverse events occurred; 4 were related to study product, and 3 led to study discontinuation.
Conclusions: In this pooled analysis, significant and continued improvements in acne lesions, scarring, and dyspigmentation were observed with once-daily CAB over 6 months of treatment, with favorable safety and tolerability. These data support the long-term use of CAB as a topical acne treatment.
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