Conditions: Actinic Keratosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 463
Healthy volunteers: no

Brief summary:
The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in a previously cleared field.

Detailed description:

Arms:
arm 1: Topical field treatment once daily for 3 consecutive days on the face or scalp arm 2: Topical field treatment once daily for 3 consecutive days on the face or scalp

Interventions: intervention 1: Ingenol mebutate gel, 0.015% intervention 2: Vehicle gel
Intervention descriptions: intervention 1: Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015% intervention 2: Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%

Protocol document: