{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,22]],"date-time":"2025-08-22T05:11:26Z","timestamp":1755839486997,"version":"3.40.5"},"reference-count":40,"publisher":"Public Library of Science (PLoS)","issue":"2","license":[{"start":{"date-parts":[[2023,2,14]],"date-time":"2023-02-14T00:00:00Z","timestamp":1676332800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research & Development, LLC","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\"><jats:title>Background<\/jats:title><jats:p>The prevalence of superficial fungal infections in India is believed to have increased substantially in the past decade. We evaluated the treatment outcomes and risk factors associated with clinical response to a treatment course of itraconazole for the management of dermatomycosis in India.<\/jats:p><\/jats:sec><jats:sec id=\"sec002\"><jats:title>Methods<\/jats:title><jats:p>In this real-world, prospective pilot study (August 2019 to March 2020), adult participants (18\u201360 years), diagnosed with<jats:italic>T<\/jats:italic>.<jats:italic>cruris<\/jats:italic>or<jats:italic>T<\/jats:italic>.<jats:italic>corporis<\/jats:italic>, received itraconazole 200 mg\/day (any formulation) orally for 7 days, and were followed for an additional 7 days.<\/jats:p><\/jats:sec><jats:sec id=\"sec003\"><jats:title>Results<\/jats:title><jats:p>The study was terminated early due to the COVID-19 pandemic. Of 40 enrolled participants (mean [SD] age, 35.5 [12.73] years; {62.5%}] male; 37 received itraconazole and 20 (50%) completed the study. The median (range) Clinical Evaluation Tool Signs and Symptoms total score at baseline was 5.5 (2\u201310). Clinical response of \u201chealed\u201d or \u201cmarkedly improved\u201d based on the Investigator Global Evaluation Tool at day 7 (primary objective) was 42.9% (12\/28; 95% CI: 24.53%, 61.19%). Itraconazole minimum inhibitory concentration for identified microorganisms,<jats:italic>T<\/jats:italic>.<jats:italic>mentagrophytes<\/jats:italic>species complex (91.7%) and<jats:italic>T<\/jats:italic>.<jats:italic>rubrum<\/jats:italic>(8.3%), was within the susceptibility range (0.015\u20130.25 mcg\/mL). At day 14, 8\/13 (61.5%) participants achieved a mycological response, 2\/13 participants (15.4%) had a mycological failure and 90% showed a clinical response.<\/jats:p><\/jats:sec><jats:sec id=\"sec004\"><jats:title>Conclusion<\/jats:title><jats:p>COVID-19 pandemic affected patient recruitment and follow-up, so the findings call for a careful interpretation. Nevertheless, this real-world study reconfirmed the clinical efficacy and microbial susceptibility to itraconazole for the fungi causing dermatophytosis in India.<\/jats:p><\/jats:sec><jats:sec id=\"sec005\"><jats:title>Trial registration<\/jats:title><jats:p>Trial registration number: Clinicaltrials.gov<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03923010\" xlink:type=\"simple\">NCT03923010<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1371\/journal.pone.0281514","type":"journal-article","created":{"date-parts":[[2023,2,14]],"date-time":"2023-02-14T18:28:26Z","timestamp":1676399306000},"page":"e0281514","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":8,"title":["No evidence of resistance to itraconazole in a prospective real-world trial of dermatomycosis in India"],"prefix":"10.1371","volume":"18","author":[{"given":"S.","family":"Handa","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Villasis-Keever","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Shenoy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Anandan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Bhrushundi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"N.","family":"Garodia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D.","family":"Fife","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P.","family":"De Doncker","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K.","family":"Shalayda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P.","family":"Hu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Fonseca","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0727-4712","authenticated-orcid":true,"given":"N.","family":"Cure-bolt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2023,2,14]]},"reference":[{"issue":"Suppl 4","key":"pone.0281514.ref001","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1111\/j.1439-0507.2008.01606.x","article-title":"Epidemiological trends in skin mycoses worldwide.","volume":"51","author":"B Havlickova","year":"2008","journal-title":"Mycoses"},{"key":"pone.0281514.ref002","doi-asserted-by":"crossref","first-page":"6","DOI":"10.1186\/s12895-018-0073-1","article-title":"Expert Consensus on The Management of Dermatophytosis in India (ECTODERM India).","volume":"18","author":"M Rajagopalan","year":"2018","journal-title":"BMC Dermatology"},{"key":"pone.0281514.ref003","doi-asserted-by":"crossref","first-page":"227","DOI":"10.4103\/ijd.IJD_206_17","article-title":"The Great Indian Epidemic of Superficial Dermatophytosis: An Appraisal","volume":"62","author":"S Verma","year":"2017","journal-title":"Indian journal of dermatology"},{"key":"pone.0281514.ref004","doi-asserted-by":"crossref","first-page":"73","DOI":"10.4103\/2229-5178.178100","article-title":"The menace of chronic and recurrent dermatophytosis in India: Is the problem deeper than we perceive?","volume":"7","author":"S Dogra","year":"2016","journal-title":"Indian dermatology online journal"},{"key":"pone.0281514.ref005","doi-asserted-by":"crossref","first-page":"154","DOI":"10.25259\/IJDVL_301_20","article-title":"The unprecedented epidemic-like scenario of dermatophytosis in India: I. 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