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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.

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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.