Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 425
Healthy volunteers: no

Brief summary:
The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK.

The secondary objective is to compare the adverse event (AE) profiles of the two creams.

Detailed description:

Arms:
arm 1: Imiquimod 5% manufactured by Taro applied for 16 weeks arm 2: Aldara, Imiquimod 5% applied for 16 weeks arm 3: Imiquimod vehicle applied for 16 weeks

Interventions: intervention 1: Imiquimod 5% manufactured by Taro intervention 2: Aldara - Imiquimod 5% intervention 3: Imiquimod Vehicle manufactured by Taro
Intervention descriptions: intervention 1: Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks intervention 2: Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks intervention 3: Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks

Protocol document: