Conditions: Acne Vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 862
Healthy volunteers: yes

Brief summary:
Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75% gel. This study is designed to evaluate the safety and efficacy of this formulation in subjects with Acne Vulgaris

Detailed description:
This is a randomized, double blind, three-arm, parallel group, placebo control bioequivalence study with clinical endpoint, at multiple study sites, designed to establish bioequivalence of clindamycin 1.2% and benzoyl peroxide 3.75% gel of Actavis and Onexton® (clindamycin 1.2% and benzoyl peroxide 3.75%) gel in the treatment of subjects with Acne Vulgaris.

The primary objective is to evaluate the bioequivalence of a generic of clindamycin 1.2% and benzoyl peroxide 3.75% gel to Onexton® in the treatment of subjects with acne vulgaris.

Arms:
arm 1: Clindamycin 1.2% and benzoyl peroxide 3.75% topical gel Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily arm 2: Generic clindamycin 1.2% and benzoyl peroxide 3.75% topical gel. Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily arm 3: A vehicle gel. Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily

Interventions: intervention 1: Onexton intervention 2: Clindamycin/benzoyl peroxide gel intervention 3: Placebo
Intervention descriptions: intervention 1: Topical gel for treating acne intervention 2: Generic Clindamycin/benzoyl peroxide gel for treating acne intervention 3: Vehicle gel used as a placebo

Protocol document: