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

S. M. Yim, J. H. Ko, Y. W. Lee, H. W. Kim, J. Y. Lee, N. I. Kim, Y. C. Kye, K. C. Park, J. H. Choi, K. H. Lee, M. N. Kim, K. J. Kim, Y. S. Ro, K. J. Ahn

    Research output: Contribution to journalArticlepeer-review

    5 Citations (Scopus)

    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.

    Original languageEnglish
    Pages (from-to)522-529
    Number of pages8
    JournalMycoses
    Volume53
    Issue number6
    DOIs
    Publication statusPublished - 2010 Nov

    Keywords

    • Fluconazole cream
    • Flutrimazole Cream
    • Randomised Controlled Trial
    • Superficial Mycosis

    ASJC Scopus subject areas

    • Dermatology
    • Infectious Diseases

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