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Dose‐finding comparative study of 2 weeks of luliconazole cream treatment for tinea pedis – comparison between three groups (1%, 0.5%, 0.1%) by a multi‐center randomised double‐blind study
Author(s) -
Watanabe Shinichi,
Takahashi Hisashi,
Nishikawa Takeji,
Takiuchi Iwao,
Higashi Nobuhiko,
Nishimoto Katsutaro,
Kagawa Saburo,
Yamaguchi Hideyo,
Ogawa Hideoki
Publication year - 2007
Publication title -
mycoses
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.13
H-Index - 69
eISSN - 1439-0507
pISSN - 0933-7407
DOI - 10.1111/j.1439-0507.2006.01305.x
Subject(s) - medicine , incidence (geometry) , double blind , adverse effect , dermatology , exact test , significant difference , surgery , placebo , pathology , physics , alternative medicine , optics
Summary Luliconazole is a newly developed imidazolyl antifungal agent. A randomised double‐blind comparative study was designed to assess the efficacy and safety of 1% luliconazole cream (group A), 0.5% cream (group B) and 0.1% cream (group C), in tinea pedis (interdigital type and plantar type), when used once daily for 2 weeks. Follow‐ups were performed at 4 weeks after the end of topical treatment. A total of 241 patients were enrolled and 213 patients were evaluated for efficacy. Rates of improvement of skin lesions in the A, B and C groups assessed at week 4 were 90.5%, 91.0% and 95.8%, respectively. Rates of mycological cure (negative result of microscopy) in the A, B and C groups assessed at week 4 were 79.7%, 76.1%, 72.2% and at week 6 (at 4 weeks after the end of topical treatment) were 87.7%, 94%, 88.9%, respectively. For the mycological effect on tinea pedis of the interdigital type at 2 weeks, the negative conversion of fungi showed a concentration‐dependent relationship and indicated a difference in tendency statistically 81.1% (1%– treatment), 62.9% (0.5%– treatment), 58.3% (0.1%– treatment) (Fisher's exact test, P = 0.079) and there was a trend between three groups by Cochran–Mantel–Haenszel method ( P = 0.038). The incidence of adverse events in which a causal relationship to this drug could not be ruled out was low (2.6%). All of the adverse events were mild in severity and insignificant clinically.