Conditions: Actinic Keratosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 589
Healthy volunteers: no

Brief summary:
To determine the comparability of the safety and efficacy of Imiquimod Cream, 3.75% and Zyclara (imiquimod) Cream, 3.75% (the reference listed drug) in subjects with actinic keratosis (AK) of the face or balding scalp. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the Vehicle cream.

Detailed description:

Arms:
arm 1: Imiquimod Cream, 3.75% (Teva) arm 2: Zyclara® (imiquimod Cream), 3.75% (Medicis) arm 3: Vehicle of Test Product (Teva)

Interventions: intervention 1: Imiquimod Cream, 3.75% intervention 2: Zyclara® intervention 3: Vehicle of Test Product
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: