An Open-Label, Multi-Centre, Dose-Escalation, Cohort Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel When Applied to a 25 cm2 Contiguous Actinic Keratoses Treatment Area on the Face or Face and Scalp.
Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or
sores on the top layer of the skin which if left untreated can progress to skin cancer.
Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long
treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Optimal tolerated regime of PEP005 Topical Gel in patients, when administered as either two day or three day application schedules to a 25 cm2 contiguous AK treatment area on the face or face and scalp
Peplin Operations Pty Ltd
Australia: Human Research Ethics Committee