Conditions: Actinic Keratosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 224
Healthy volunteers: no

Brief summary:
Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days

Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle

Detailed description:

Arms:
arm 1: Open-label, dose-escalation, 2-day treatment arm 2: LEO 43204 dose 0.1% once daily for two consecutive days arm 3: LEO 43204 dose 0.075% once daily for two days arm 4: Placebo once daily for two days

Interventions: intervention 1: LEO 43204 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: