{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T20:41:28Z","timestamp":1778791288437,"version":"3.51.4"},"reference-count":48,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2011,12,20]],"date-time":"2011-12-20T00:00:00Z","timestamp":1324339200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2013,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:bold>Background\u2002<\/jats:bold> Terbinafine nail solution (TNS) was developed for the treatment of onychomycosis.<\/jats:p><jats:p><jats:bold>Objective\u2002<\/jats:bold> To assess the efficacy of TNS vs. vehicle and amorolfine 5% nail lacquer.<\/jats:p><jats:p><jats:bold>Methods\u2002<\/jats:bold> Subjects with mild\u2010to\u2010moderate toe onychomycosis (25% to \u226475% nail\u2010involvement, matrix uninvolved) were randomized to receive either TNS or vehicle in two double\u2010blind studies, and to TNS or amorolfine in an active\u2010controlled, open\u2010label study. Primary endpoint was complete cure (no residual clinical involvement and negative mycology) at week 52. Secondary endpoints were mycological cure (negative mycology defined as negative KOH microscopy and negative culture) and clinical effectiveness (\u226410% residual\u2010involvement and negative mycology) at week 52.<\/jats:p><jats:p><jats:bold>Results\u2002<\/jats:bold> Complete cure was not different between TNS vs. vehicle and amorolfine. Mycological cure was higher with TNS vs. vehicle, as was clinical effectiveness with TNS vs. vehicle, and TNS and amorolfine were not different for secondary efficacy endpoints. Patients achieving mycological cure had a better clinical outcome, and efficacy was improved in subjects with milder disease. <jats:italic>Post hoc<\/jats:italic> analysis suggests that nail thickness is an important prognostic factor. Moreover, mycological cure may require 6\u2003months of treatment regimen while complete cure and clinical effectiveness may be achievable only after 10\u2003months. A simulation study suggests that longer treatment duration would have resulted in higher complete cure with TNS vs. vehicle. Study treatments were well\u2010tolerated.<\/jats:p><jats:p><jats:bold>Conclusion\u2002<\/jats:bold> Primary efficacy objectives were not met in the studies reported herein. Possible reasons for failure to achieve significant outcomes include insufficient length of treatment; stringency of primary endpoint and severity of nail involvement of study population.<\/jats:p>","DOI":"10.1111\/j.1468-3083.2011.04373.x","type":"journal-article","created":{"date-parts":[[2011,12,20]],"date-time":"2011-12-20T11:48:19Z","timestamp":1324381699000},"page":"287-294","source":"Crossref","is-referenced-by-count":59,"title":["Efficacy, safety and tolerability of topical terbinafine nail solution in patients with mild\u2010to\u2010moderate toenail onychomycosis: results from three randomized studies using double\u2010blind vehicle\u2010controlled and open\u2010label active\u2010controlled designs"],"prefix":"10.1111","volume":"27","author":[{"given":"B.E.","family":"Elewski","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.A.","family":"Ghannoum","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P.","family":"Mayser","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.K.","family":"Gupta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H.\u2010C.","family":"Korting","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R.J.","family":"Shouey","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D.R.","family":"Baker","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P.A.","family":"Rich","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Ling","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Hugot","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B.","family":"Damaj","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Nyirady","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K.","family":"Thangavelu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Notter","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Parneix\u2010Spake","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B.","family":"Sigurgeirsson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2011,12,20]]},"reference":[{"key":"e_1_2_8_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.1992.tb00005.x"},{"key":"e_1_2_8_3_2","doi-asserted-by":"publisher","DOI":"10.1001\/archderm.1997.03890450124022"},{"key":"e_1_2_8_4_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.1995.tb00722.x"},{"key":"e_1_2_8_5_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.1995.tb02741.x"},{"key":"e_1_2_8_6_2","doi-asserted-by":"publisher","DOI":"10.1080\/000155502762064665"},{"key":"e_1_2_8_7_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-4362.1997.00349.x"},{"key":"e_1_2_8_8_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1439-0507.2004.00968.x"},{"key":"e_1_2_8_9_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2133.1998.02464.x"},{"key":"e_1_2_8_10_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1439-0507.2005.01140.x"},{"key":"e_1_2_8_11_2","doi-asserted-by":"publisher","DOI":"10.2165\/00128071-200001010-00002"},{"key":"e_1_2_8_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0190-9622(98)70199-9"},{"key":"e_1_2_8_13_2","doi-asserted-by":"publisher","DOI":"10.1023\/A:1008986826756"},{"key":"e_1_2_8_14_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-3083.2004.00988.x"},{"key":"e_1_2_8_15_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.2007.07974.x"},{"key":"e_1_2_8_16_2","first-page":"26","article-title":"Fungal nail infections: diagnosis and management","volume":"18","author":"Prescrire R","year":"2009","journal-title":"Prescrire Int"},{"key":"e_1_2_8_17_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1529-8019.2007.00109.x"},{"key":"e_1_2_8_18_2","doi-asserted-by":"publisher","DOI":"10.1517\/13543780902810352"},{"key":"e_1_2_8_19_2","first-page":"965","volume-title":"Biology of Hair and Nails. 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