Conditions: Actinic Keratosis
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 320
Healthy volunteers: no

Brief summary:
Part 1:

To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once daily treatment for two consecutive days

Part 2:

To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations

Detailed description:

Arms:
arm 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment arm 2: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment arm 3: Double-Blind, Once-Daily, 2-Day Treatment arm 4: Double-Blind, Once-Daily, 2-Day Treatment arm 5: Double-Blind, Once-Daily, 2-Day Treatment arm 6: Double-Blind, Once-Daily, 2-Day Treatment arm 7: Double-Blind, Once-Daily, 2-Day Treatment arm 8: Double-Blind, Once-Daily, 2-Day Treatment

Interventions: intervention 1: LEO 43204 Formulation 1 intervention 2: LEO 43204 Formulation 2 intervention 3: LEO 43204 Formulation 1 Dose X intervention 4: LEO 43204 Formulation 1 Dose Y intervention 5: LEO 43204 Formulation 2 Dose XX intervention 6: LEO 43204 Formulation 2 Dose YY intervention 7: Placebo Formulation 1 intervention 8: Placebo Formulation 2
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None

Protocol document: