{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T06:52:04Z","timestamp":1777877524380,"version":"3.51.4"},"reference-count":18,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Laboratorios Salvat S A"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Otolaryngology - Head & Neck Surgery"],"published-print":{"date-parts":[[2025,1]]},"abstract":"\n Importance<\/jats:title>\n There is no antifungal otic drug for the treatment of otomycosis approved in the United States. Some current clotrimazole formulations in the market are used off-label.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the efficacy and safety of clotrimazole 1% otic solution compared to placebo in treating otomycosis in adults.<\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n Two independent twin multicenter, randomized (2:1), double-blind, controlled clinical trials with identical designs were conducted from February 2020 to October 2021.<\/jats:p>\n <\/jats:sec>\n \n Setting<\/jats:title>\n Fifty-three sites located in the United States, Mexico, and Europe.<\/jats:p>\n <\/jats:sec>\n \n Participants<\/jats:title>\n Adults with uncomplicated otomycosis presented with symptoms, debris, and drainage clinically consistent with fungal infection.<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n Patients received clotrimazole or placebo twice daily for 14\u2009days and were evaluated on visit 1 (day 1), visit 2 (day 8-10), visit 3 (day 15), and follow-up visit 4 (day 24-26).<\/jats:p>\n <\/jats:sec>\n \n Main Outcome Measures<\/jats:title>\n At each visit, pruritus, otalgia, otorrhea, and ear fullness were assessed. Ear exudate was taken for a mycological and microbiological evaluation at baseline and, if present, at subsequent visits. The primary endpoint was a therapeutic cure (mycological and clinical) at visit 4 in the randomized population with positive fungal culture at baseline [mycological intent-to-treat (MITT)].<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Three hundred ninety-three patients received study medication (261 clotrimazole and 132 placebo). Efficacy data from the 228 patients (157 clotrimazole and 71 placebo) included in the MITT were analyzed. The clotrimazole group achieved a higher proportion for the primary endpoint than those with the placebo group (68.2% vs 25.4%;\n P<\/jats:italic>\n \u2009<\u2009.0001), with a 42.8 difference in response rate (95% confidence interval: 30.3, 55.3). The treatment was safe and well tolerated, with 2.7% of related adverse events in the clotrimazole versus 1.5% in the placebo group.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Clotrimazole 1% otic solution has demonstrated its superiority over the placebo in each study and the pooled analysis. These are the results of the first international, multicenter clinical trials in which clotrimazole 1% otic solution demonstrates efficacy for the treatment of otomycosis.<\/jats:p>\n <\/jats:sec>","DOI":"10.1177\/19160216251330629","type":"journal-article","created":{"date-parts":[[2025,6,25]],"date-time":"2025-06-25T02:40:26Z","timestamp":1750819226000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Pooled Analysis of 2 Randomized Clinical Trials to Evaluate the Efficacy and Safety of Clotrimazole 1% Otic Solution for the Treatment of Otomycosis in Adults"],"prefix":"10.1177","volume":"54","author":[{"given":"Ansley","family":"J.F.","sequence":"first","affiliation":[{"name":"Carolina ENT Clinic (Centri Inc.), Orangeburg, Hickory, SC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8191-9833","authenticated-orcid":false,"given":"Bernal-Sprekelsen","family":"M.","sequence":"additional","affiliation":[{"name":"University of Barcelona Medical School, Hospital Clinic, Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Butehorn","family":"H.F.","sequence":"additional","affiliation":[{"name":"Spartanburg Ear, Nose and Throat\u2013Head and Neck Clinic, P.A., Spartanburg, SC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Todorov","family":"S.","sequence":"additional","affiliation":[{"name":"UMHAT Tsaritsa Yoanna ISUL, Sofia, Bulgaria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tzvetkov","family":"V.","sequence":"additional","affiliation":[{"name":"Military Medical Academy Multiprofile Hospital for Active Treatment\u2013ENT Clinica, Sofia, Bulgaria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Douglis","family":"F.","sequence":"additional","affiliation":[{"name":"ENT Allergy Snoring Center, Conroe, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5587-0853","authenticated-orcid":false,"given":"Georgiev","family":"K.","sequence":"additional","affiliation":[{"name":"Military Medical Academy Multiprofile Hospital for Active Treatment, Varna, Bulgaria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Moreira da Silva","family":"F.","sequence":"additional","affiliation":[{"name":"Hospital da Senhora da Oliveira, Guimaraes, Braga, Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,4,15]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1017\/S0022215120001164"},{"issue":"1","key":"e_1_3_3_3_2","first-page":"78","article-title":"Efficacy of topical clotrimazole in treatment of otomycosis","volume":"25","author":"Khan F","year":"2013","unstructured":"Khan F, Muhammad R, Khan MR, et al Efficacy of topical clotrimazole in treatment of otomycosis. J Ayub Med Coll Abbottabad. 2013;25(1-2):78-80.","journal-title":"J Ayub Med Coll Abbottabad"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijporl.2007.12.005"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.7759\/CUREUS.30098"},{"key":"e_1_3_3_6_2","unstructured":"Salvat. SVT-15652 Otic Solution for the Treatment of Otomycosis NCT03686384. U.S. National Library of Medecine. Published 2021. Accessed July 26 2023. https:\/\/www.clinicaltrials.gov\/study\/NCT03686384?term=SVT-15652&cond=Otomycosis&rank=2"},{"key":"e_1_3_3_7_2","unstructured":"Salvat. SVT-15652 Otic Solution for the Treatment of Otomycosis NCT03686397. National Library of Medicine. Published 2021. Accessed July 26 2023. https:\/\/www.clinicaltrials.gov\/study\/NCT03686397?term=SVT-15652&cond=Otomycosis&rank=1"},{"issue":"6","key":"e_1_3_3_8_2","first-page":"358","article-title":"Estudio clinico para evaluar la efectividad de ciprofloxacino otico al 0.3% en ninos con otitis externa difusa","volume":"58","author":"Claros Blanch P","year":"2000","unstructured":"Claros Blanch P, Sanchez Garcia F, Rodriguez Leal A, Gomez Vida J, Llanes Domingo S. Estudio clinico para evaluar la efectividad de ciprofloxacino otico al 0.3% en ninos con otitis externa difusa. Acta Pediatr Esp. 2000;58(6):358-362.","journal-title":"Acta Pediatr Esp"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD009289.pub2"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1128\/cmr.12.1.40"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1288\/00005537-198811000-00005"},{"issue":"4","key":"e_1_3_3_12_2","article-title":"Efficacy of topical clotrimazole in otomycosis","volume":"5","author":"Hamza A","unstructured":"Hamza A, Khan Q, Khan M. Efficacy of topical clotrimazole in otomycosis. PJMHS. 2011;5(4):738\u2013740.","journal-title":"PJMHS"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12070-014-0780-9"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12070-022-03206-x"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.7874\/JAO.2018.00276"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1002\/LARY.25761"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.14260\/jemds\/2018\/462"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.bjorl.2017.04.004"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjoto.2018.03.017"}],"container-title":["Journal of Otolaryngology - Head & Neck Surgery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/19160216251330629","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/19160216251330629","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/19160216251330629","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T22:53:42Z","timestamp":1777589622000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/19160216251330629"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1]]},"references-count":18,"alternative-id":["10.1177\/19160216251330629"],"URL":"https:\/\/doi.org\/10.1177\/19160216251330629","relation":{},"ISSN":["1916-0216","1916-0216"],"issn-type":[{"value":"1916-0216","type":"print"},{"value":"1916-0216","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1]]},"article-number":"19160216251330629"}}