Conditions: Actinic Keratosis
Keywords: Peplin Actinic keratosis PEP005
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 265
Healthy volunteers: no

Brief summary:
This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None

Interventions: intervention 1: PEP005 Topical Gel intervention 2: PEP005 Topical Gel intervention 3: PEP005 Topical Gel intervention 4: Vehicle gel intervention 5: PEP005 Topical Gel intervention 6: PEP005 Topical Gel intervention 7: PEP005 Topical Gel intervention 8: Vehicle gel
Intervention descriptions: intervention 1: 0.005%, two days treatment intervention 2: 0.01%, two days treatment intervention 3: 0.015%, two days treatment intervention 4: two days treatment intervention 5: 0.005%, three days treatment intervention 6: 0.01%, three days treatment intervention 7: 0.015%, three days treatment intervention 8: three days treatment

Protocol document: