Conditions: Acne Vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1018
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Subjects will use Duac™Once Daily Gel (once daily in the evening)for 12 weeks. The subjects will be evaluated for change in lesion counts, ISGA, 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 arm 2: Subjects will use 1% clinidamycin phosphate gel (twice daily in the morning and evening)for 12 weeks. The subjects will be evaluated for change in lesion counts, ISGA, 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

Interventions: intervention 1: Duac™Once Daily Gel intervention 2: 1% clindamycin phosphate gel
Intervention descriptions: intervention 1: 1% clindamycin as clindamycin phosphate and 5% benzoyl peroxide intervention 2: 1% clindamycin as clindamycin phosphate

Protocol document: