{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T12:08:01Z","timestamp":1775736481084,"version":"3.50.1"},"reference-count":60,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,6,17]],"date-time":"2025-06-17T00:00:00Z","timestamp":1750118400000},"content-version":"vor","delay-in-days":16,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100012155","name":"National Institute for Medical Research Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100012155","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004160","name":"Mazandaran University of Medical Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004160","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Mycoses"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Oral terbinafine (TBF) is the drug of choice for onychomycosis management. To treat and heal the rough and thick nail tissue affected by fungal agents, a high dose and plasma concentration of this drug is necessary. This, however, poses a life\u2010threatening risk due to the cytotoxic side effects, drug\u2013drug interactions, and adverse physical and chemical properties associated with oral medications.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>This study aimed to employ nanostructured lipid carriers (NLCs) in a gel formulation to avoid side effects and to increase the absorption of topical TBF.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Terbinafine\u2010loaded nanostructured lipid carriers (TBF\u2010NLCs) were developed and optimised using an ultrasonic probe technique, resulting in the formulation of TBF\u2010NLCs as a 1% w\/w carbopol gel after verifying the characteristics associated with NLCs. In\u00a0vitro antifungal susceptibility test (AFST) was conducted on 85 prevalent fungal species associated with onychomycosis, as well as on strains isolated from trial participants, following the CLSI M38\u2010A2 and M27\u2010A3 guidelines. A total of 60 volunteers were enrolled in this clinical randomised, double\u2010blind, placebo\u2010controlled study, divided equally into three groups prescribed with TBF cream 1%, TBF\u2010NLCs gel 1%, and a placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A monodisperse suspension of spherical nanoparticles was successfully produced, exhibiting a zeta potential of 18.4\u2009\u00b1\u20091.02\u2009mV, a Z\u2010average of 131.7\u2009\u00b1\u20095.32\u2009nm, a PDI index of 0.280\u2009\u00b1\u20090.017, and an EE percentage of 83.51\u2009\u00b1\u20093.52, all without any cytotoxic effects. The severity index showed a reduction from 65% and 55% to 35% and 10% in the TBF cream 1% and TBF\u2010NLCs groups, respectively. From a mycological perspective, no significant negative results were noted during the 6th and 8th weeks of TBF\u2010NLC 1% gel application.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The application of TBF\u2010NLCs gel 1% demonstrated a quicker clinical recovery without adverse side effects compared to TBF cream, thus highlighting the effective nature of NLCs.<\/jats:p><\/jats:sec>","DOI":"10.1111\/myc.70076","type":"journal-article","created":{"date-parts":[[2025,6,17]],"date-time":"2025-06-17T04:44:30Z","timestamp":1750135470000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A Double\u2010Blind Randomised Clinical Trial of Terbinafine\u2010Nanostructured Lipid Carriers: Should We Anticipate This Strategy for Effective Topical Treatment of 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