A Efficacy and Safety of Duac™Compared With Clindamycin Phosphate Gel in the Treatment of Mild to Moderate Acne Vulgaris

Summary

This is a multicentre, randomized, assessor-blind, comparator-controlled evaluation of the efficacy, safety, and tolerability of Duac™Once Daily Gel and clindamycin phosphate gel in the topical treatment of mild to moderate facial acne vulgaris. A total of 1020 subjects will be enrolled, 510 per study arm. The subjects will be males and females between 12 and 45 years of age, inclusive, at the time of consent, who have mild to moderate facial acne vulgaris. Subjects will use Duac™Once Daily Gel (once daily in the evening) or clindamycin phosphate gel twice daily (once in the morning and once in the evening) for 12 weeks. The subjects will be evaluated for change in lesion counts, investigator's static global assessment (ISGA), subject's global assessment (SGA), local tolerability and AEs/SAEs at Weeks0, 1, 2, 4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be performed at every study visit.

Timeline

Start

2013-04

Primary completion

2014-04

Completion

2014-04

Publications

• Xu JH, Lu QJ, Huang JH, Hao F, Sun QN, Fang H, Gu J, Dong XQ, Zheng J, Luo D, Li FQ, Wang G, Gu H, Tian HQ, Yang HL, Xi LY, Li M, Zheng M, Wu Y, Tu YT, He YL, Zhao G, Sheng WX, Li J, Hamedani AG. A multicentre, randomized, single-blind comparison of topical clindamycin 1%/benzoyl peroxide 5% once-daily gel versus clindamycin 1% twice-daily gel in the treatment of mild to moderate acne vulgaris in Chinese patients. J Eur Acad Dermatol Venereol. 2016 Jul;30(7):1176-82. doi: 10.1111/jdv.13622. Epub 2016 Apr 13.

Drugs

Indications