{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,8]],"date-time":"2026-02-08T04:27:28Z","timestamp":1770524848707,"version":"3.49.0"},"reference-count":27,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2015,2,27]],"date-time":"2015-02-27T00:00:00Z","timestamp":1424995200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"LEO Pharma, Brazil"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2015,9]]},"abstract":"Abstract<\/jats:title>Background<\/jats:title>Five per cent 5\u2010fluorouracil (5\u2010FU<\/jats:styled-content>) cream is a well\u2010established treatment for actinic keratosis (AK<\/jats:styled-content>), and ingenol mebutate gel (IMB<\/jats:styled-content>) is a novel topical field\u2010directed therapy.<\/jats:p><\/jats:sec>Objective<\/jats:title>To compare the tolerability and safety of IMB<\/jats:styled-content> with that of 5\u2010FU<\/jats:styled-content> for the treatment of facial AK<\/jats:styled-content>.<\/jats:p><\/jats:sec>Methods<\/jats:title>An open\u2010label, prospective, randomized, controlled clinical trial with 100 patients with AK<\/jats:styled-content>s within a 25\u2010cm2<\/jats:sup> contiguous field on the face was conducted. IMB<\/jats:styled-content> was applied daily for three consecutive days. 5\u2010FU<\/jats:styled-content> was applied twice a day for 4\u00a0weeks. 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\u2010to\u2010treat populations.<\/jats:p><\/jats:sec>Results<\/jats:title>The mean (\u00b1SD<\/jats:styled-content>) maximum local skin reactions (LSR<\/jats:styled-content>) for patients treated with IMB<\/jats:styled-content> was 10.85 (\u00b1 3.12), compared with 10.86 (\u00b1 3.55) for those who received 5\u2010FU<\/jats:styled-content>. Patients in the IMB<\/jats:styled-content> group presented LSR<\/jats:styled-content> that peaked at day 4 and almost completely regressed after 15\u00a0days. Differently, in the 5\u2010FU<\/jats:styled-content> group, the LSR<\/jats:styled-content> peaked at day 29 and lasted until visit 36. Additionally, the area under the curve (LSR<\/jats:styled-content>\u00a0\u00d7\u00a0visit) was significantly smaller for IMB<\/jats:styled-content>. No differences between the treatments for pruritus, pain, tearing, conjunctival hyperaemia or headaches were noted, but the eyelid oedema rate was higher for IMB<\/jats:styled-content> group. No significant difference in the proportion of dropouts was observed between groups. Both treatments demonstrated a suitable safety profile.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>For treating AK<\/jats:styled-content>s, the local skin reactions in the IMB<\/jats:styled-content> group were more short\u2010lived compared with those of 5\u2010FU<\/jats:styled-content>, but both treatments seemed to be safe and tolerable.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.13063","type":"journal-article","created":{"date-parts":[[2015,2,27]],"date-time":"2015-02-27T15:52:59Z","timestamp":1425052379000},"page":"1822-1827","source":"Crossref","is-referenced-by-count":24,"title":["Evaluation of the tolerability and safety of a 0.015% ingenol mebutate gel compared to 5% 5\u2010fluorouracil cream for the treatment of facial actinic keratosis: a prospective randomized trial"],"prefix":"10.1111","volume":"29","author":[{"given":"L.P.","family":"Samorano","sequence":"first","affiliation":[{"name":"Department of Dermatology Hospital das Cl\u00ednicas University of S\u00e3o Paulo 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