A comparative clinical study between 2 weeks of luliconazole 1% cream treatment and 4 weeks of bifonazole 1% cream treatment for tinea pedis

Authors: Watanabe, Shinichi¹; Takahashi, Hisashi¹; Nishikawa, Takeji²; Takiuchi, Iwao³; Higashi, Nobuhiko⁴; Nishimoto, Katsutaro⁵; Kagawa, Saburo⁶; Yamaguchi, Hideyo⁷; Ogawa, Hideoki⁸

Source: Mycoses, Volume 49, Number 3, May 2006 , pp. 236-241(6)

Publisher: Blackwell Publishing

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Abstract:

Summary

The aim of the study was to compare the efficacy and safety of luliconazole 1% cream and bifonazole 1% cream as applied in the treatment of tinea pedis (interdigital-type and plantar-type). A multi-clinic, randomised single-blind, parallel group study with 34 hospitals and 11 clinics formed the study design. Five hundred and eleven patients with mycologically confirmed tinea pedis were included. Of the 489 evaluable patients, 247 were randomised to luliconazole, and 242 to bifonazole. Luliconazole 1% cream applied once a day for 2 weeks, followed by a placebo cream for 2 weeks, thereafter. Bifonazole 1% cream applied once a day for 4 weeks. Mycological effect (negative result on microscopy) and improvement of skin lesions were measured at weeks 1, 2, 3 and 4. Safety frequency and severity of adverse reactions were also measured. The improvement of skin lesions after 4 weeks was comparably good with rates of 91.5% vs. 91.7% (luliconazole vs. bifonazole). The mycological effect was characterised by high negative rates of 76.1% vs. 75.9% (luliconazole vs. bifonazole). The progression of tinea-related signs and symptom scores differed insignificantly between evaluated luliconazole and bifonazole treatment groups comprising a total of 500 patients. Both substances appeared to be comparably safe and well-tolerated.

Keywords: new antimycotic; luliconazole; phase III comparative clinical study

Document Type: Research article

DOI: 10.1111/j.1439-0507.2006.01218.x

Affiliations: 1: Department of Dermatology, Teikyo University School of Medicine, Itabashi 2: Department of Dermatology, Keio University School of Medicine, Shinjuku, Tokyo 3: Department of Dermatology, Showa University Fujigaoka Hospital, Aoba, Yokohama 4: Department of Dermatology, Municipal Sakai Hospital, Sakai, Osaka 5: Department of Dermatology, Nagasaki Municipal Hospital, Shinchi-machi, Nagasaki 6: Department of Dermatology, Showa University School of Medicine Higashi Hospital, Nishi nakanobu, Shinagawa, Tokyo 7: Teikyo University, Institute of Medical Mycology, Otsuka, Hachioji, Tokyo 8: Department of Dermatology, Juntendo University School of Medicine, Bunkyo, Tokyo, Japan

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