Conditions: Acne
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 480
Healthy volunteers: yes

Brief summary:
The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.

Detailed description:
Not required

Arms:
arm 1: treatment of acne for 12 weeks arm 2: Treatment of acne for 12 weeks arm 3: Treatment if acne for 12 weeks as placebo

Interventions: intervention 1: Tretinoin microsphere 0.1% intervention 2: Brand Retin-A Micro tretinoin microsphere gel 0.1% intervention 3: placebo microsphere gel
Intervention descriptions: intervention 1: Treatment of acne vulgaris intervention 2: Treatment of acne vulgaris intervention 3: treatment of acne vulgaris

Protocol document: