A Seamless Phase 1/2 Exploratory Multi-centre, Investigator-blind, Dose Escalation Study (Study Part 1), Followed by a Randomised, Intra-subject, Active Controlled Efficacy Study of Different Ingenol Mebutate Formulations Applied to the Forearm for 2 Consecutive Days (Study Part 2)
This study will be run in 2 parts. The first part involves applying escalating
concentrations of the new vehicle formulations containing ingenol mebutate to AKs on the
forearms. Reactions and safety will be compared to Picato® (a registered and marketed
ingenol mebutate gel) to ascertain if the new vehicle formulations are at least as safe and
effective as Picato® . The purpose of part 2 is to select the concentration in the "new
formulation" that produces this same, if not better response, as Picato® and with a similar
or better safety profile.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Safety of 3 new vehicle formulations containing ingenol mebutate compared to Picato® 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. Relative skin reactions for comparison to Picato®.
Lynda Spelman, MD
Australia: National Health and Medical Research Council