Conditions: Acne Vulgaris
Keywords: Acne Acne Vulgaris Pimples
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 591
Healthy volunteers: no

Brief summary:
Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris.

You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.

Detailed description:
The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks.

Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at every visit to determine how the study drug is working. Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals from the study.

Arms:
arm 1: Benzoyl peroxide/clindamycin gel + tazarotene cream arm 2: Benzoyl peroxide/clindamycin gel + vehicle cream arm 3: Benzoyl peroxide gel + tazarotene cream arm 4: Clindamycin gel + tazarotene cream arm 5: Vehicle gel+ tazarotene cream arm 6: Vehicle gel + vehicle cream

Interventions: intervention 1: Benzoyl peroxide gel intervention 2: Clindamycin gel intervention 3: Tazarotene cream intervention 4: Vehicle gel intervention 5: Vehicle cream
Intervention descriptions: intervention 1: 5% benzoyl peroxide in a gel applied topically once a day intervention 2: 1% clindamycin phosphate applied topically once a day intervention 3: 0.1 % tazarotene in a cream applied topically once a day intervention 4: Vehicle gel is an identical gel without the active ingredients intervention 5: Vehicle cream is an identical cream without the active ingredients

Protocol document: