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Study of the Efficacy, Tolerability, and Safety of 2 Fixed-Dose Combination Gels in the Management of Acne Vulgaris
Zouboulis CC, Fischer TC, Wohlrab J, Barnard J, Alió AB
Cutis. 2009;84:223-229.
abstract
This study investigated the efficacy, tolerability, and safety of 2 fixed-dose combination gels for the treatment of facial acne: clindamycin 1%–benzoyl peroxide 5% gel with hydrating excipients (C/BPO HE) and adapalene 0.1%–benzoyl peroxide 2.5% gel (A/BPO). After 12 weeks of once daily treatment, the mean reduction in inflammatory lesion count was 76.8% and 72.2% in the C/BPO HE group and A/BPO group, respectively (P=.076). Significantly more participants achieved treatment success, which was defined as an improvement of 2 grades or more from baseline to week 12 on the investigator’s static global assessment (ISGA) scale, with C/BPO HE (30.5% [58/190]) compared with A/BPO (21.8% [42/192])(P=.046), and treatment success was achieved more quickly with C/BPO HE (PP<.05). Treatment-related adverse events (AEs) occurred in 48.4% (92/190) of participants in the C/BPO HE group compared with 78.6% (151/192) of the A/BPO group. We conclude that C/BPO HE and A/BPO have similar efficacy in treating inflammatory and noninflammatory acne lesions, but C/BPO HE achieves better overall treatment success in less time coupled with a significantly better tolerability profile and notably better safety profile.
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