Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels in the management of acne vulgaris.

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 25% 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 (P = .035). Both products also reduced noninflammatory (62.2% C/BPO HE vs 6 1.5% A/BPO) and total lesion counts (69.1% C/BPO HE vs 67.1% A/BPO). Despite the overall similar efficacy profile, C/BPO HE was better tolerated and safer than A/BPO. In the tolerability assessments, erythema, dryness, peeling, pruritus, and burning/ stinging were more frequent in the A/BPO group at all time points from week 1 onward (P < .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.

• Authors: Christos C Zouboulis, Tanja C Fischer, Johannes Wohlrab, Jo Barnard, Alessandra B Alió
• Journal: Cutis (Cutis) Vol. 84 Issue 4 Pg. 223-9 (Oct 2009) ISSN: 0011-4162 [Print] United States
• PMID: 19911678 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Dermatologic Agents
• Drug Combinations
• Excipients
• Gels
• Naphthalenes
• clindamycin phosphate benzoyl peroxide combination
• Adapalene
• Clindamycin
• Benzoyl Peroxide

Topics

• Acne Vulgaris (drug therapy)
• Adapalene
• Adolescent
• Adult
• Anti-Bacterial Agents (adverse effects, therapeutic use)
• Benzoyl Peroxide (administration & dosage, adverse effects, therapeutic use)
• Child
• Clindamycin (administration & dosage, adverse effects, therapeutic use)
• Dermatologic Agents (administration & dosage, adverse effects, therapeutic use)
• Drug Combinations
• Excipients (chemistry)
• Female
• Gels
• Humans
• Male
• Middle Aged
• Naphthalenes (administration & dosage, adverse effects, therapeutic use)
• Prospective Studies
• Single-Blind Method
• Treatment Outcome
• Young Adult