Conditions: Actinic Keratosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 367
Healthy volunteers: no

Brief summary:
The purpose of this trial is to compare the rate of complete clearance of actinic keratosis (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.

Detailed description:

Arms:
arm 1: Cryotherapy followed by PEP005 Gel, 0.015% arm 2: Cryotherapy followed by vehicle gel

Interventions: intervention 1: Cryotherapy intervention 2: Vehicle intervention 3: Ingenol metabute
Intervention descriptions: intervention 1: Cryotherapy of all visible AKs (4-8 lesions, "baseline lesions") in the selected treatment area intervention 2: Field treatment with vehicle gel once daily for 3 consecutive days. intervention 3: Field treatment with vehicle gel once daily for 3 consecutive days.

Protocol document: