A Phase 1 Exploratory Trial Evaluating Safety and Tolerability of Topical Administration of Different Concentrations of an Ingenol Derivative Compared to Ingenol Mebutate Gel 0.05% Applied on Two Consecutive Days to Four Separate 25cm2 Treatment Areas on the Forearms of Subjects With Actinic Keratosis (Field Therapy)
Various concentrations of new ingenol derivatives will be applied to AKs on the forearms.
Reactions and safety will be compared to a US registered and marketed ingenol gel to
ascertain if the new ingenol is at least as safe and as well tolerated as the registered
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Safety of a new ingenol derivative compared to ingenol mebutate gel applied topically once daily for two consecutive days to four separate treatment areas containing actinic keratosis on the forearm
Safety data to be collected via CRF entries of AEs/SAEs and photographs.
Hans P Soyer
Dermatology Department, Brisbane Public Hospital
Australia: National Health and Medical Research Council