Conditions: ACTINIC KERATOSIS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 507
Healthy volunteers: no

Brief summary:
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic comparability of the two active products and the superiority of the two active products over the vehicle gel in the treatment of AK on the face and scalp.

Detailed description:
Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the Food and Drug Administration (FDA) in 2012 for the topical treatment of AKs on the face and scalp (0.015% formulation) and on the trunk and extremities (0.05% formulation). The FDA approved regimen for ingenol mebutate gel, 0.015% for the treatment of AKs on the face and scalp is once-daily application of one unit dose tube for three consecutive days applied to one contiguous skin area of approximately 25 cm2 (e.g., 5 cm x 5 cm).

Arms:
arm 1: Picato® (ingenol mebutate) gel, 0.15% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\] arm 2: Generic ingenol mebutate gel, 0.15% \[Test\] 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:
Prot_000.pdf: 
 
 
 
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PARALLEL 
GROUP COMPARISON STUDY TO DETERMINE THE THERAPEUTIC EQUIVALENCE OF A 
GENERIC INGENOL MEBUTATE GEL, 0.015% AND PICATO® GEL, 0.015% IN SUBJECTS WITH 
ACTINIC KERATOSIS ON THE FACE OR SCALP 
 
 
 
NCT03200912 
 
 
 
 
Protocol dated: May 26, 2016 













































































































SAP_001.pdf: 
 
 
 
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PARALLEL 
GROUP COMPARISON STUDY TO DETERMINE THE THERAPEUTIC EQUIVALENCE OF A 
GENERIC INGENOL MEBUTATE GEL, 0.015% AND PICATO® GEL, 0.015% IN SUBJECTS WITH 
ACTINIC KERATOSIS ON THE FACE OR SCALP 
 
 
 
NCT03200912 
 
 
 
 
SAP dated: November 26, 2016