Spots Global Cancer Trial Database for Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm

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Trial Identification

Brief Title: Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm

Official Title: 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)

Study ID: NCT01803477

Conditions

Actinic Keratosis

Interventions

once daily for two consecutive days (Picato)

Study Description

Brief Summary: The purpose of this study is to determine if the new vehicle formulations containing ingenol mebutate are as safe and effective as Picato® gel 0.05% (it's current vehicle formulation) when applied to AK lesions on the forearm for two consecutive days.

Detailed Description: 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.