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Study to compare the efficacy and safety of fluconazole cream with flutrimazole cream in the treatment of superficial mycosis: a multicentre, randomised, double-blind, phase III trial

Cited 5 time in Web of Science Cited 4 time in Scopus
Authors
Yim, S. M.; Ko, J. H.; Lee, Y. W.; Kim, H. W.; Kim, N. I.; Park, K. C.; Lee, K. H.; Kim, K. J.; Ahn, K. J.; Ro, Y. S.; Kim, M. N.; Choi, J. H.; Kye, Y. C.; Lee, J. Y.
Issue Date
2010-11
Publisher
WILEY-BLACKWELL
Citation
MYCOSES; Vol.53(6); 522-529
Keywords
Fluconazole creamrandomised controlled trialsuperficial mycosisflutrimazole cream
Abstract
Fluconazole, which is a drug of the azole family, is safely used in systemic treatment of oral and intravenous injection, but it is difficult to use fluconazole as a topical application because of its large molecular weight and strong hydrophilic property. This study is a multicentre, double-blind, randomised, non-inferiority study to compare the antifungal effect and safety of fluconazole cream 0.5% and 1% with flutrimazole cream 1% in superficial mycosis. A total of 162 subjects selected to participate in this study were equally divided into three groups and assigned to be given fluconazole cream 0.5%, fluconazole cream 1%, and flutrimazole cream 1% in the ratio of 1 : 1. The primary index of drug efficacy was determined by complete mycological cure in which no fungus was detected on KOH smear test 4 weeks after application of fluconazole. The secondary index of efficacy was defined as complete mycological cure 4 weeks after the application of fluconazole, improvement of clinical symptoms and overall effectiveness assessed by the research staff. According to this study, on comparing the efficacy of cure of superficial dermatomycosis after 4 weeks of application, both fluconazole 0.5% and fluconazole 1% cream were found to be equally effective and non-inferior to flutrimazole 1% cream. Given the effectiveness and safety of the drug, both fluconazole 0.5% and 1% cream might be said to be optimal concentration in the treatment of superficial dermatomycosis.
ISSN
0933-7407
Language
English
URI
https://hdl.handle.net/10371/78289
DOI
https://doi.org/10.1111/j.1439-0507.2009.01738.x
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College of Medicine/School of Medicine (의과대학/대학원)Dermatology (피부과학전공)Journal Papers (저널논문_피부과학전공)
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