Conditions: Actinic Keratosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 441
Healthy volunteers: no

Brief summary:
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis (AK) on the trunk or extremities.

Detailed description:
Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the FDA in 2012 for the topical treatment of AK(s) on the face and scalp (0.015% formulation) and on the trunk and extremities (0.05% formulation). A generic ingenol mebutate gel, 0.05% has been developed for the topical treatment of clinically typical, visible, and discrete non-hyperkeratotic, non-hypertrophic AK lesions of the trunk or extremities.

Arms:
arm 1: Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\] arm 2: Generic ingenol mebutate gel, 0.05% \[Test\] arm 3: Vehicle gel of the test product

Interventions: intervention 1: Ingenol Mebutate (Picato®) intervention 2: Generic Ingenol Mebutate intervention 3: Vehicle Foam
Intervention descriptions: intervention 1: Brand product intervention 2: Generic formulated to have the same therapeutic effect of the brand intervention 3: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.

Protocol document: