{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T12:07:25Z","timestamp":1775736445603,"version":"3.50.1"},"reference-count":36,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2022,11,17]],"date-time":"2022-11-17T00:00:00Z","timestamp":1668643200000},"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":[[2023,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>A new water\u2010soluble formulation with ciclopirox has shown a higher penetration than other ciclopirox nail lacquers currently marketed, thus providing a higher concentration of ciclopirox into the nail.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the efficacy and safety of a new ciclopirox nail hydrolacquer compared with its vehicle and an active comparator (hydroxypropyl chitosan\u2010based 80\u2009mg\/g ciclopirox nail lacquer) for the treatment of toenail fungal infection.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Phase III, multicenter, randomised, double\u2010blind, clinical trial in patients with distal mild to moderate toenail onychomycosis due to dermatophyte fungi. Patients were randomised to apply topically a ciclopirox nail hydrolacquer, its vehicle or a reference product once daily for 48\u2009weeks with a follow\u2010up period of 4\u2009weeks up to week 52.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 381 patients were included. No statistically significant differences were observed between patient groups in the proportion of subjects achieving a complete cure. At week 52, a higher percentage of patients in the ciclopirox nail hydrolacquer group achieved a mycological cure (negative for culture and DTS\/KOH test, with results: 32.0% ciclopirox nail hydrolacquer, 23.2% vehicle and 27% reference product, respectively), and similar results were found for improvement (mycological cure and reduction of diseased nail \u226520%, with results: 27.2% ciclopirox nail hydrolacquer, 21.6% vehicle and 20.6% reference product, respectively). Regarding mycological results, only ciclopirox nail hydrolacquer demonstrated significant statistical superiority versus vehicle negativizing dermatophyte culture (<jats:italic>p<\/jats:italic>\u00a0=\u00a0.039) with no recurrences, relapses or re\u2010infections in a four\u2010week follow\u2010up patients with complete cure. The safety profile was comparable to the vehicle and reference product and consistent with the previously reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>A new water\u2010soluble formulation for a ciclopirox nail lacquer showed similar efficacy to the reference product to eradicate toenail onychomycosis and superiority in the mycological cure defined by negative culture, thus preventing reinfections and recurrences. Efficacy and safety data demonstrate the positive benefit\u2013risk profile of this new topical antifungal preparation. [Correction added on 13 April 2023, after first online publication: The results and conclusions in the Abstract contained incorrect information and were revised in this version.]<\/jats:p><\/jats:sec>","DOI":"10.1111\/myc.13543","type":"journal-article","created":{"date-parts":[[2022,11,7]],"date-time":"2022-11-07T08:09:08Z","timestamp":1667808548000},"page":"566-575","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Efficacy and safety of a new medicated nail hydrolacquer in the treatment of adults with toenail onychomycosis: A randomised clinical trial"],"prefix":"10.1111","volume":"66","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4127-8968","authenticated-orcid":false,"given":"Antonio J.","family":"Zalacain\u2010Vicu\u00f1a","sequence":"first","affiliation":[{"name":"Podiatry School. Faculty of Medicine and Health Sciences University of Barcelona  L'Hospitalet de Llobregat Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlos","family":"Nieto","sequence":"additional","affiliation":[{"name":"Laboratorio Reig Jofre  Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jordi","family":"Picas","sequence":"additional","affiliation":[{"name":"Laboratorio Reig Jofre  Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5947-6888","authenticated-orcid":false,"given":"Helena","family":"Mart\u00ednez","sequence":"additional","affiliation":[{"name":"Laboratorio Reig Jofre  Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rafael","family":"Bermejo","sequence":"additional","affiliation":[{"name":"Laboratorio Reig Jofre  Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adri\u00e1n","family":"Corrales","sequence":"additional","affiliation":[{"name":"Laboratorio Reig Jofre  Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francisco Fern\u00e1ndez","family":"Campos","sequence":"additional","affiliation":[{"name":"Laboratorio Reig Jofre  Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Soledad\u00a0Anguiano","family":"Igea","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Pharmacy and Pharmaceutical Technology University of Santiago de Compostela  Santiago de Compostela Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francisco Javier","family":"Otero\u2010Espinar","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Pharmacy and Pharmaceutical Technology University of Santiago de Compostela  Santiago de Compostela Spain"},{"name":"Institute of Materials iMATUS. 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