Evaluation of the tolerability and safety of a 0.015% ingenol mebutate gel compared to 5% 5‐fluorouracil cream for the treatment of facial actinic keratosis: a prospective randomized trial

• DOI: 10.1111/jdv.13063
• Publication Date: 2015-02-27T15:52:59Z
• Authors: L.P. Samorano; L.A. Torezan; J.A. Sanches
• Keywords: Tolerability; Actinic keratosis

Five per cent 5-fluorouracil (5-FU) cream is a well-established treatment for actinic keratosis (AK), and ingenol mebutate gel (IMB) novel topical field-directed therapy.To compare the tolerability safety of IMB with that 5-FU facial AK.An open-label, prospective, randomized, controlled clinical trial 100 patients AKs within 25-cm(2) contiguous field on face was conducted. applied daily three consecutive days. twice day 4 weeks. The effect adverse events were evaluated at baseline days 2, 3, 4, 8, 15, 22, 29, 36 43 intent-to-treat populations.The mean (± SD) maximum local skin reactions (LSR) treated 10.85 3.12), compared 10.86 3.55) those who received 5-FU. Patients in group presented LSR peaked almost completely regressed after 15 Differently, group, 29 lasted until visit 36. Additionally, area under curve (LSR × visit) significantly smaller IMB. No differences between treatments pruritus, pain, tearing, conjunctival hyperaemia or headaches noted, but eyelid oedema rate higher group. significant difference proportion dropouts observed groups. Both demonstrated suitable profile.For treating AKs, more short-lived 5-FU, both seemed to be safe tolerable.