Conditions: Actinic Keratosis
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 395
Healthy volunteers: no

Brief summary:
To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle gel

Detailed description:

Arms:
arm 1: Open-label, dose escalation, 3 days treatment arm 2: Randomized, 3 days treatment arm 3: Randomized 2 days treatment arm 4: Randomized 3 days treatment arm 5: Randomized 2 days treatment arm 6: Randomized 3 days treatment arm 7: Randomized 2 days treatment arm 8: Open-label, dose escalation, 3 days treatment arm 9: Open-label, dose escalation, 3 days treatment arm 10: Open-label, dose escalation, 3 days treatment arm 11: Open-label, dose escalation, 3 days treatment arm 12: Open-label, dose escalation, 2 days treatment arm 13: Open-label, dose escalation, 3 days treatment arm 14: Open-label, dose escalation, 2 days treatment

Interventions: intervention 1: Ingenol mebutate gel intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: