Conditions: Acne Vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 73
Healthy volunteers: no

Brief summary:
To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to Retin-A Micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3 weeks in terms of local tolerability parameters (erythema, dryness, scaling, stinging/burning) and preference.

Detailed description:
Adult subjects with acne vulgaris will receive tretinoin gel 0.1% on one side of the face and adapalene 0.1% / benzoyl peroxide 2.5% gel on the other side of the face once daily for a period 3 weeks (22 days). Tolerability assessments (erythema, dryness, scaling, stinging/burning)on both sides of the face will be taken on each visit, on each weekday from from baseline to day 22. The investigator and subjects will respond to user preference questions on days 5, 12, 19, and 22.

Arms:
arm 1: Adapalene 0.1% and benzoyl peroxide 2.5% gel arm 2: Tretinoin gel, 0.1%

Interventions: intervention 1: Epiduo Gel intervention 2: Retin-A Micro Microsphere 0.1%
Intervention descriptions: intervention 1: Once-daily application of fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel. intervention 2: Once-daily application of tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.

Protocol document: