A Efficacy and Safety of Duac™Compared With Clindamycin Phosphate Gel in the Treatment of Mild to Moderate Acne Vulgaris
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
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.