{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T14:35:04Z","timestamp":1787841304264,"version":"build-2784847793"},"reference-count":11,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2019,7]]},"abstract":"\n Background:<\/jats:title>\n It is a challenge to treat onychomycosis due to frequent treatment failures and relapses. Systemic and topical therapies need to be combined to improve cure rates. Antifungal susceptibility might play a role in the treatment resistance of onychomycosis.<\/jats:p>\n <\/jats:sec>\n \n Aims:<\/jats:title>\n To compare the safety and effectiveness of amorolfine 5% nail lacquer + oral fluconazole versus only oral fluconazole in the treatment of fingernail onychomycosis.<\/jats:p>\n <\/jats:sec>\n \n Methodology:<\/jats:title>\n \n In this double-blind trial (CTRI\/2015\/02\/005369), patients were randomized (1:1) into amorolfine 5% nail lacquer + fluconazole and dummy lacquer + fluconazole. Treatment was given for 3 months with monthly follow-ups. Antifungal sensitivity was carried out for\n Candida<\/jats:italic>\n . Effectiveness was assessed by reduction in the number and percentage area of nails involved and mycological cure. At the end of 3-month treatment period, the association between drug sensitivity and treatment response was explored for the\n Candida<\/jats:italic>\n infections.\n <\/jats:p>\n <\/jats:sec>\n \n Results:<\/jats:title>\n \n Among 30 study participants, the combination group showed significantly lower number of nail involvement (\n P<\/jats:italic>\n = 0.004) and percentage nail involvement (\n P<\/jats:italic>\n = 0.005) than only fluconazole group. Pretreatment fungal culture showed a comparable number of dermatophytes,\n Candida<\/jats:italic>\n ,\n Aspergillus<\/jats:italic>\n in both the groups. Sensitivity testing was done for the isolated\n Candida<\/jats:italic>\n species. Antifungal sensitivity for\n Candida<\/jats:italic>\n (\n n<\/jats:italic>\n = 11) was tested, and 8 (72.7%) of the organisms were sensitive to fluconazole (minimum inhibitory concentration [MIC] 1.25 \u00b1 1.19 \u03bcg\/ml), 100% were sensitive to itraconazole (MIC 0.0726 \u00b1 0.021 \u03bcg\/ml), and 3 (27.3%) were susceptible-dose dependent (S-DD) to fluconazole (MIC 16 \u03bcg\/ml). Fluconazole only group patients with\n Candida<\/jats:italic>\n who showed resistance to fluconazole did not respond to therapy; however, patients in the combination group showed moderate improvement (reduction in area involvement = 55.56 \u00b1 35.36%).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion:<\/jats:title>\n The combination of amorolfine\/fluconazole achieved a higher cure rate not only for sensitive fungus but also for those which were S-DD to fluconazole.<\/jats:p>\n <\/jats:sec>","DOI":"10.4103\/ijd.ijd_385_17","type":"journal-article","created":{"date-parts":[[2019,7,5]],"date-time":"2019-07-05T04:14:30Z","timestamp":1562300070000},"page":"253-260","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":3,"title":["A Randomized, Double-blind Study of Amorolfine 5% Nail Lacquer with Oral Fluconazole Compared with Oral Fluconazole Alone in the Treatment of Fingernail Onychomycosis"],"prefix":"10.4103","volume":"64","author":[{"given":"Somodyuti","family":"Chandra","sequence":"first","affiliation":[{"name":"From the Department of Dermatology, Medical College, Rampurhat, Birbhum, West Bengal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karan","family":"Sancheti","sequence":"additional","affiliation":[{"name":"From the Department of Dermatology, Medical College, Rampurhat, Birbhum, West Bengal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Indrashis","family":"Podder","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Sagore Datta Medical College, Rampurhat, Birbhum, West Bengal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anupam","family":"Das","sequence":"additional","affiliation":[{"name":"Department of Dermatology, KPC Medical College, Rampurhat, Birbhum, West Bengal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tushar Kanti","family":"Sarkar","sequence":"additional","affiliation":[{"name":"From the Department of Dermatology, Medical College, Rampurhat, Birbhum, West Bengal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moitreyee","family":"Chowdhury","sequence":"additional","affiliation":[{"name":"Department of Biochemistry, Medical College, Rampurhat, Birbhum, West Bengal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amrita","family":"Sil","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Rampurhat Government Medical College, Rampurhat, Birbhum, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susmita","family":"Bhattacharya","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Kalyani Medical College, Nadia, West Bengal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nilay Kanti","family":"Das","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"R1-20250921","doi-asserted-by":"crossref","first-page":"497","DOI":"10.1111\/j.1365-2710.2009.01107.x","article-title":"Toenail onychomycosis: An important global disease burden","volume":"35","author":"Thomas","year":"2010","journal-title":"J Clin Pharm Ther"},{"key":"R2-20250921","doi-asserted-by":"crossref","first-page":"301","DOI":"10.1159\/000080853","article-title":"Chronic dermatomycoses of the foot as risk factors for acute bacterial cellulitis of the leg: A case-control study","volume":"209","author":"Roujeau","year":"2004","journal-title":"Dermatology"},{"key":"R3-20250921","doi-asserted-by":"crossref","first-page":"1202","DOI":"10.2337\/dc05-2031","article-title":"Prediction of diabetic foot ulcer occurrence using commonly available clinical information: The Seattle diabetic foot study","volume":"29","author":"Boyko","year":"2006","journal-title":"Diabetes Care"},{"key":"R4-20250921","first-page":"23","article-title":"Combination of amorolfine with griseofulvin: In vitro activity and clinical results in onychomycosis","volume":"9","author":"Lauharanta","year":"1993","journal-title":"JAMA Sea"},{"key":"R5-20250921","first-page":"143","article-title":"Quality of life indices","volume":"70","author":"Finlay","year":"2004","journal-title":"Indian J Dermatol Venereol Leprol"},{"key":"R6-20250921","doi-asserted-by":"crossref","first-page":"235","DOI":"10.1093\/clinids\/24.2.235","article-title":"Development of interpretive breakpoints for antifungal susceptibility testing: Conceptual framework and analysis of in vitro in vivo correlation data for fluconazole, itraconazole, and candida infections. Subcommittee on Antifungal Susceptibility Testing of the National Committee for Clinical Laboratory Standards","volume":"24","author":"Rex","year":"1997","journal-title":"Clin Infect Dis"},{"key":"R8-20250921","doi-asserted-by":"crossref","first-page":"e1004105","DOI":"10.1371\/journal.ppat.1004105","article-title":"Fungal nail infections (onychomycosis): A never-ending story","volume":"10","author":"Ghannoum","year":"2014","journal-title":"PLoS Pathog"},{"key":"R9-20250921","doi-asserted-by":"crossref","first-page":"1177","DOI":"10.1046\/j.1365-2133.2000.03545.x","article-title":"A randomized trial of amorolfine 5% solution nail lacquer combined with oral terbinafine compared with terbinafine alone in the treatment of dermatophytic toenail onychomycoses affecting the matrix region","volume":"142","author":"Baran","year":"2000","journal-title":"Br J Dermatol"},{"issue":"Suppl 1","key":"R10-20250921","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1159\/000247588","article-title":"Preclinical data and mode of action of amorolfine","volume":"184","author":"Polak","year":"1992","journal-title":"Dermatology"},{"key":"R11-20250921","doi-asserted-by":"crossref","first-page":"151","DOI":"10.1046\/j.1365-2133.2003.05381.x","article-title":"A randomized trial of amorolfine 5% solution nail lacquer in association with itraconazole pulse therapy compared with itraconazole alone in the treatment of candida fingernail onychomycosis","volume":"149","author":"Rigopoulos","year":"2003","journal-title":"Br J Dermatol"},{"key":"R12-20250921","doi-asserted-by":"crossref","first-page":"635","DOI":"10.1016\/S0891-5520(03)00063-1","article-title":"Clinical pharmacodynamics of antifungals","volume":"17","author":"Andes","year":"2003","journal-title":"Infect Dis Clin North Am"}],"container-title":["Indian Journal of Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/00076423-201964040-00001","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T13:49:16Z","timestamp":1787838556000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/00076423-201964040-00001"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,7]]},"references-count":11,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2019]]}},"URL":"https:\/\/doi.org\/10.4103\/ijd.ijd_385_17","relation":{},"ISSN":["0019-5154","1998-3611"],"issn-type":[{"value":"0019-5154","type":"print"},{"value":"1998-3611","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,7]]},"assertion":[{"value":"2017-08-01","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-08-01","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}