Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm
Phase 1/Phase 2
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.
Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis
Background: 5% 5-fluorouracil cream (5-FU) is a well-established treatment for actinic
keratosis (AK) and ingenol mebutate gel (IMB) is a new topical field therapy.
Objective: To compare tolerability and safety of IMB with 5-FU for the treatment of facial
Methods: Open-label, prospective, randomized, controlled clinical trial with 100 patients
with AKs within 25-cm2 contiguous field on the face. IMB was applied daily for three
consecutive days. 5-FU was applied twice a day for four weeks. Treatment effect was
evaluated at baseline and on days 2, 3, 4, 8, 15, 22, 29, 36 and 43, considering ITT
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