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

Journal of the European Academy of Dermatology and Venereology : JEADV
L P SamoranoJ A Sanches

Abstract

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

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Citations

Nov 3, 2015·Expert Opinion on Drug Safety·Brian Berman
Apr 8, 2016·The Journal of Dermatological Treatment·William C HankeStephen Stone
Nov 1, 2016·Der Hautarzt; Zeitschrift für Dermatologie, Venerologie, und verwandte Gebiete·T Hommel, R-M Szeimies
Mar 7, 2017·Journal of the European Academy of Dermatology and Venereology : JEADV·G Goldenberg
Aug 4, 2018·Expert Opinion on Drug Metabolism & Toxicology·Eggert Stockfleth, Mike Bastian
Aug 2, 2018·Anais Brasileiros De Dermatologia·Maria Isabel Ramos SaraivaAndrezza Telles Westin
May 4, 2017·MMW Fortschritte der Medizin·Harald P M Gollnick Em
Dec 4, 2019·Anais Brasileiros De Dermatologia·Clarissa Prieto Herman Reinehr, Renato Marchiori Bakos
Jan 1, 2018·Anais Brasileiros De Dermatologia·Maria Isabel Ramos SaraivaAndrezza Telles Westin

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