{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T23:34:48Z","timestamp":1793230488815,"version":"4.5.0"},"reference-count":21,"publisher":"American Society for Microbiology","issue":"6","license":[{"start":{"date-parts":[[2013,6,1]],"date-time":"2013-06-01T00:00:00Z","timestamp":1370044800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2013,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>The study objective was to evaluate the safety, tolerability, systemic exposure, and pharmacokinetics (PK) of 10% luliconazole solution (luliconazole) when topically applied once daily to all 10 toenails and periungual areas in patients with moderate to severe distal subungual onychomycosis. In this single-center, open-label study, 24 patients applied 20 mg\/ml of luliconazole (twice the clinical dose) for 29 days with a 7-day follow-up. Complete PK profiles were determined on days 1, 8, 15, and 29. Safety\/tolerability assessments included application site reactions, adverse events, vital signs, clinical laboratory findings, and electrocardiograms. Mean luliconazole plasma concentrations remained around the lower limit of quantitation (0.05 ng\/ml) and were comparable on days 8, 15, and 29 (range, 0.063 to 0.090 ng\/ml), suggesting steady state occurred by day 8. Every patient had undetectable plasma luliconazole levels for at least 11% of the time points, and 12 of the 24 patients had undetectable levels for at least 70% of the time points. The maximum plasma concentration of luliconazole (<jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub>) observed in any patient was 0.314 ng\/ml and the maximum area under the concentration-time curve from 0 to 24 h (AUC<jats:sub>0\u201324<\/jats:sub>) was 4.34 ng \u00b7 h\/ml. Five patients (21%) had measureable luliconazole levels in the plasma 7 days after the last dose. The median concentration of luliconazole in the nail at this time point was 34.65 mg\/g (from 42 of 48 collected toenail samples). There was one mild incidence of skin erythema on day 5 that resolved on day 8, there were no reports of drug-induced systemic side effects, and there was no evidence of QT prolongation. Luliconazole, when applied once daily to all 10 fungus-infected toenails for 29 days, is generally safe and well tolerated and results in significant accumulation of drug in the nail. Systemic exposure is very low, with no evidence of drug accumulation.<\/jats:p>","DOI":"10.1128\/aac.02370-12","type":"journal-article","created":{"date-parts":[[2013,4,2]],"date-time":"2013-04-02T01:53:52Z","timestamp":1364867632000},"page":"2684-2689","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":38,"title":["Safety and Tolerability of Luliconazole Solution 10-Percent in Patients with Moderate to Severe Distal Subungual Onychomycosis"],"prefix":"10.1128","volume":"57","author":[{"given":"T.","family":"Jones","sequence":"first","affiliation":[{"name":"J &amp; S Studies, Inc., College Station, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Tavakkol","sequence":"additional","affiliation":[{"name":"Topica Pharmaceuticals, Inc., Los Altos, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1529-8019.2007.00109.x"},{"key":"e_1_3_2_3_2","doi-asserted-by":"crossref","first-page":"255","DOI":"10.2340\/00015555-0224","article-title":"Health-related quality of life and nail disorders","volume":"87","author":"Tabolli S","year":"2007","unstructured":"TabolliS AlessandroniL GaidoJ SampognaF Di PietroC AbeniD. 2007. Health-related quality of life and nail disorders. Acta Derm. Venereol. 87:255\u2013259.","journal-title":"Acta Derm. Venereol"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.11.3.415"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2006.12.019"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2710.2009.01107.x"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.2165\/00128071-200001010-00002"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.2165\/11592120-000000000-00000"},{"key":"e_1_3_2_9_2","first-page":"299","article-title":"Safety and tolerability of oral antifungal agents in the treatment of fungal nail disease: a proven reality","volume":"1","author":"Elewski B","year":"2005","unstructured":"ElewskiB TavakkolA. 2005. Safety and tolerability of oral antifungal agents in the treatment of fungal nail disease: a proven reality. Ther. Clin. 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Drugs Dermatol"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10156-004-0327-1"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.05255-11"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10156-006-0440-4"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1080\/13693780802541518"},{"key":"e_1_3_2_17_2","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1111\/j.1610-0387.2008.06751.x","article-title":"The significance of itraconazole for treatment of fungal infections of skin, nails and mucous membranes","volume":"7","author":"Korting HC","year":"2009","unstructured":"KortingHC SchollmannC. 2009. The significance of itraconazole for treatment of fungal infections of skin, nails and mucous membranes. J. Dtsch. Dermatol. Ges. 7:11\u201320.","journal-title":"J. Dtsch. Dermatol. Ges"},{"key":"e_1_3_2_18_2","first-page":"AB111","article-title":"Terbinafine HCl in a novel alcohol vehicle permeates the human nail and achieves therapeutic concentrations in the nail plate and nail bed","volume":"60","author":"Waldmeier F","year":"2009","unstructured":"WaldmeierF LehmanP FranzT PfisterW. 2009. Terbinafine HCl in a novel alcohol vehicle permeates the human nail and achieves therapeutic concentrations in the nail plate and nail bed. J. Am. Acad. Dermatol. 60:AB111.","journal-title":"J. Am. Acad. Dermatol"},{"key":"e_1_3_2_19_2","volume-title":"Lulicon cream 1% and Lulicon solution 1% package insert","author":"Pola Chemical Industry (currently Pola Pharma)","year":"2005","unstructured":"Pola Chemical Industry (currently Pola Pharma). 2005. Lulicon cream 1% and Lulicon solution 1% package insert. Pola Pharma, Yokohama, Japan."},{"key":"e_1_3_2_20_2","first-page":"AB107","article-title":"Minimal systemic exposure of a new topical triazole antifungal, efinaconazole 10% solution, in patients with severe onychomycosis following 28-day treatment","volume":"68","author":"Crean C","year":"2013","unstructured":"CreanC AkinoriA OhA KangR. 2013. Minimal systemic exposure of a new topical triazole antifungal, efinaconazole 10% solution, in patients with severe onychomycosis following 28-day treatment. J. Am. Acad. Dermatol. 68(Suppl.):AB107.","journal-title":"J. Am. Acad. Dermatol"},{"key":"e_1_3_2_21_2","first-page":"AB104","article-title":"Efinaconazole 10% solution a new triazole antifungal developed for topical onychomycosis treatment: nail penetration and systemic absorption","volume":"68","author":"Sakamoto M","year":"2013","unstructured":"SakamotoM KoderaN SugimotoN PillaiR. 2013. 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Aventis Pharmaceuticals Inc., Lansdale, PA."}],"container-title":["Antimicrobial Agents and Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.02370-12","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.02370-12","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,8]],"date-time":"2024-05-08T05:56:10Z","timestamp":1715147770000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/AAC.02370-12"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,6]]},"references-count":21,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2013,6]]}},"alternative-id":["10.1128\/AAC.02370-12"],"URL":"https:\/\/doi.org\/10.1128\/aac.02370-12","relation":{},"ISSN":["0066-4804","1098-6596"],"issn-type":[{"value":"0066-4804","type":"print"},{"value":"1098-6596","type":"electronic"}],"subject":[],"published":{"date-parts":[[2013,6]]},"assertion":[{"value":"2012-12-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2013-03-23","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2013-05-14","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}