Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
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
AKs.
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 populations.