{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T14:54:15Z","timestamp":1787756055731,"version":"build-2784847793"},"reference-count":36,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2014,9,25]],"date-time":"2014-09-25T00:00:00Z","timestamp":1411603200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/3.0\/"}],"funder":[{"name":"Almirall S.A."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2015,5]]},"abstract":"Abstract<\/jats:title>Background<\/jats:title>Actinic keratoses (AK<\/jats:styled-content>s) are clinically significant and require therapy. Efficacy of low\u2010dose (0.5%) 5\u2010fluorouracil with 10% salicylic acid (5\u2010FU<\/jats:styled-content>\/SA<\/jats:styled-content>) has been shown in randomized comparative trials of hyperkeratotic lesions of various grades.<\/jats:p><\/jats:sec>Objectives<\/jats:title>To evaluate the efficacy, tolerability and safety of low\u2010dose 5\u2010FU<\/jats:styled-content>\/SA<\/jats:styled-content> topical solution vs. cryosurgery in patients with moderate\/severe (grade II<\/jats:styled-content>\/III<\/jats:styled-content>) hyperkeratotic AK<\/jats:styled-content>s (NCT<\/jats:styled-content>01358851).<\/jats:p><\/jats:sec>Methods<\/jats:title>In an exploratory, open, randomized study, patients with histologically confirmed moderate\/severe hyperkeratotic AK<\/jats:styled-content>s on the face\/forehead or bald scalp received 6\u00a0weeks of once\u2010daily topical 0.5% 5\u2010FU<\/jats:styled-content>\/SA<\/jats:styled-content>, or up to two cryosurgery treatments (3\u00a0weeks apart). Histological outcomes were determined from punch biopsies. Clinical, cosmetic and tolerability outcomes were also assessed.<\/jats:p><\/jats:sec>Results<\/jats:title>Sixty\u2010six patients received treatment (33 per arm). The baseline total number of lesions was 266 (8.1\/patient) in the 0.5% 5\u2010FU<\/jats:styled-content>\/SA<\/jats:styled-content> and 263 (8.0\/patient) in the cryosurgery group. Most (74.5%) lesions were grade II<\/jats:styled-content> (grade III<\/jats:styled-content>, 25.5%). Mean change in lesion count from baseline to Day 98 was \u22125.2\u00a0and \u22125.7\u00a0lesions per patient for 0.5% 5\u2010FU<\/jats:styled-content>\/SA<\/jats:styled-content> and cryotherapy groups respectively. Histological AK<\/jats:styled-content> clearance rates on Day 98 were 62.1% and 41.9% respectively. At 6\u2010month posttreatment follow\u2010up, recurrence of cleared lesions (no clinically visible lesions in treatment area) occurred in 39.4% of 0.5% 5\u2010FU<\/jats:styled-content>\/SA<\/jats:styled-content> and 84.8% of cryosurgery patients. Drug\u2010related adverse events (AE<\/jats:styled-content>s), including local skin reactions considered \u2018severe\u2019 by the investigator, were reported in 24.2% of 0.5% 5\u2010FU<\/jats:styled-content>\/SA<\/jats:styled-content> and 6.1% of cryosurgery patients. All drug\u2010related AE<\/jats:styled-content>s were skin reactions.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>Although the study was not powered to explore statistical differences in clinical efficacy between treatments, a short (6\u2010week) schedule of topical treatment with 0.5% 5\u2010FU<\/jats:styled-content>\/SA<\/jats:styled-content> achieved greater histological clearance and lower recurrence of grade II<\/jats:styled-content>\/III<\/jats:styled-content> hyperkeratotic AK<\/jats:styled-content>s than cryosurgery. AE<\/jats:styled-content> incidence across both treatment groups was relatively low and AE<\/jats:styled-content>s were generally mild or moderate. Clinical trials.gov identifier: NCT01358851.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.12702","type":"journal-article","created":{"date-parts":[[2014,9,25]],"date-time":"2014-09-25T23:58:18Z","timestamp":1411689498000},"page":"881-889","source":"Crossref","is-referenced-by-count":47,"title":["A prospective randomized exploratory study comparing the efficacy of once\u2010daily topical 0.5% 5\u2010fluorouracil in combination with 10.0% salicylic acid (5\u2010FU<\/scp>\/SA<\/scp>) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis"],"prefix":"10.1111","volume":"29","author":[{"given":"J.\u2010C.","family":"Simon","sequence":"first","affiliation":[{"name":"Department of Dermatology Venereology and Allergology University of Leipzig Medical Center Leipzig Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"Dominicus","sequence":"additional","affiliation":[{"name":"Proderma D\u00fclmen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Karl","sequence":"additional","affiliation":[{"name":"Private practice Soest Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"Rodr\u00edguez","sequence":"additional","affiliation":[{"name":"Almirall, S.A. Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Willers","sequence":"additional","affiliation":[{"name":"Almirall, S.A. Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Dirschka","sequence":"additional","affiliation":[{"name":"Faculty of Health Private University of Witten\u2010Herdecke Witten and Centroderm clinic, Wuppertal Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,9,25]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"SterryW Guideline Subcommittee of the European Dermatology Forum.Guidelines for the management of actinic keratoses\u2013Update2011. URLhttp:\/\/www.euroderm.org\/. (last accessed: 29 August 2014)."},{"key":"e_1_2_8_3_1","unstructured":"National Institute for Clinical Excellence.Guidance on Cancer Services: Improving outcomes for people with skin tumours including melanoma. The manual. 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