{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,25]],"date-time":"2026-04-25T10:00:46Z","timestamp":1777111246333,"version":"3.51.4"},"reference-count":23,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2021,12,6]],"date-time":"2021-12-06T00:00:00Z","timestamp":1638748800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Mycoses"],"published-print":{"date-parts":[[2022,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Onychomycosis is a difficult\u2010to\u2010treat fungal nail infection whose treatment can involve systemic or topical antifungal approaches.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To assess the efficacy and safety of terbinafine 10% nail lacquer in distal\u2010lateral subungual onychomycosis (DLSO).<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients\/Methods<\/jats:title><jats:p>Patients with mild\u2010to\u2010moderate DLSO were randomised (3:3:1) to receive double\u2010blind topical terbinafine 10% (<jats:italic>n<\/jats:italic>\u00a0=\u00a0406) or its vehicle (<jats:italic>n<\/jats:italic>\u00a0=\u00a0410) administered once daily for 4\u00a0weeks and then once weekly for 44\u00a0weeks, or open\u2010label topical amorolfine 5% (<jats:italic>n<\/jats:italic>\u00a0=\u00a0137) for 48\u00a0weeks, with a 12\u2010week follow\u2010up period. The primary efficacy endpoint, complete cure rate at Week 60, was a composite of negative potassium hydroxide (KOH) microscopy, negative culture for dermatophytes and no residual clinical involvement of the target big toenail.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Complete cure rates at Week 60 in the terbinafine, vehicle and amorolfine groups were 5.67%, 2.20% and 2.92%, respectively (odds ratio (OR) vs vehicle\u00a0=\u00a02.68; 95% confidence intervals (CI): 1.22\u20135.86; <jats:italic>p<\/jats:italic>\u00a0=\u00a0.0138). Statistically significant differences in responder (negative KOH and negative culture and \u226410% residual clinical involvement) and mycological cure rates (negative KOH and negative culture) at Week 60 were obtained between terbinafine and vehicle. Terbinafine was well\u2010tolerated with no systemic adverse reactions identified; the most common topical adverse reactions were erythema and skin irritation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Terbinafine 10% nail lacquer was an effective treatment for mild\u2010to\u2010moderate onychomycosis improving both clinical and mycological criteria compared with vehicle. Furthermore, there may be some benefits compared to the currently available topical agent, amorolfine 5%. Treatment was well\u2010tolerated and safe.<\/jats:p><\/jats:sec>","DOI":"10.1111\/myc.13392","type":"journal-article","created":{"date-parts":[[2021,11,9]],"date-time":"2021-11-09T18:01:05Z","timestamp":1636480865000},"page":"392-401","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["A multicentre, randomised, parallel\u2010group, double\u2010blind, vehicle\u2010controlled and open\u2010label, active\u2010controlled study (versus amorolfine 5%), to evaluate the efficacy and safety of terbinafine 10% nail lacquer in the treatment of onychomycosis"],"prefix":"10.1111","volume":"65","author":[{"given":"Ulrike","family":"Blume\u2010Peytavi","sequence":"first","affiliation":[{"name":"Department of Dermatology, Venereology and Allergology Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonella","family":"Tosti","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Cutaneous Surgery Fredric Brandt Endowed Professor of Dermatology and Cutaneous Surgery University of Miami Miami Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meritxell","family":"Falqu\u00e9s","sequence":"additional","affiliation":[{"name":"Almirall Research and Development Center Sant Feliu de Llobregat Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Luisa","family":"Tamarit","sequence":"additional","affiliation":[{"name":"Almirall Research and Development Center Sant Feliu de Llobregat Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina","family":"Carre\u00f1o","sequence":"additional","affiliation":[{"name":"Almirall Research and Development Center Sant Feliu de Llobregat Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jordi","family":"Galv\u00e1n","sequence":"additional","affiliation":[{"name":"Almirall Global Medical Affairs Department Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veronica","family":"Tebbs","sequence":"additional","affiliation":[{"name":"Island View Consulting Ltd. Dronfield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,12,6]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2133.1999.00007.x"},{"key":"e_1_2_9_3_1","first-page":"49","article-title":"Update on terbinafine with a focus on dermatophytoses","volume":"2","author":"Newland JG","year":"2009","journal-title":"Clin Cosmet Investig Dermatol"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.g1800"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.3390\/jof1010030"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1159\/000485632"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijd.14346"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2018.05.1260"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.6547247"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.1992.tb00001.x"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.2165\/00128071-200304010-00005"},{"key":"e_1_2_9_12_1","unstructured":"eMC.Loceryl\u00aeNail Lacquer 5%. 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