Long-Term Efficacy and Tolerability of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: A 24-Week Trial

Abstract

Introduction: Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel—the only fixed-dose, triple-combination topical approved for acne—demonstrated superior efficacy to vehicle and component dyads, with favorable safety/tolerability in phase 2 and phase 3 trials of moderate to severe acne. However, compared with the 12-week treatment time-course in these trials, real-world acne treatment may require many months for maximum benefits to be seen. Furthermore, acne sequelae (eg, scarring; dyspigmentation) can persist long after lesion resolution. This trial assessed CAB’s long-term efficacy/tolerability and reductions in acne scarring/dyspigmentation.

Methods: This 24-week, single-center, open-label trial assessed once-daily CAB in participants aged ≥12 years with moderate acne (Investigator’s Global Assessment [IGA] score=3). Endpoints included change from baseline in IGA score and percent change in inflammatory/noninflammatory lesions. Investigator-assessed skin appearance (dryness, scarring, post-inflammatory hyperpigmentation [PIH], post-inflammatory erythema [PIE]) and participant-assessed tolerability (itching, burning, redness, swelling) were evaluated on a 5-point scale (0 [none] to 4 [severe]). Adverse events were also assessed.

Results: Of the 25 participants, mean age was 24 years (range: 12–51 years), 80% were female, and over half (56%) had Fitzpatrick skin type V and VI. At week 24, 68% of participants achieved treatment success (≥2-grade reduction in IGA score from baseline and clear/almost clear skin), with significant reductions in inflammatory and noninflammatory lesions (89% and 70%, respectively; P<0.001 vs baseline, both). Decreases from baseline to week 24 in PIH (77%), PIE (84%), and scarring severity (33%) were statistically significant (P≤0.001, all). There were no increases in skin dryness and no statistically significant tolerability issues identified by participants (mean scores <0.25 at all timepoints). No adverse events or adverse experiences occurred during the trial.

Conclusions: CAB gel was well tolerated and led to significant and continued improvements in acne over 6 months of once-daily use. At week 24, inflammatory acne lesions were reduced by nearly 90%, with significant improvements in acne-related scarring and dyspigmentation. No new safety or tolerability signals were observed. These results support the long-term use of CAB in the topical treatment of acne.

Funding: Ortho Dermatologics.