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.
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.
Watanabe
Shinichi
S
Department of Dermatology, Teikyo University School of Medicine, Itabashi, Tokyo, Japan. watanabe@med.teikyo-u.ac.jp
Takahashi
Hisashi
H
Nishikawa
Takeji
T
Takiuchi
Iwao
I
Higashi
Nobuhiko
N
Nishimoto
Katsutaro
K
Kagawa
Saburo
S
Yamaguchi
Hideyo
H
Ogawa
Hideoki
H
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D014008:Tinea Pedis / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome
D000935:Antifungal Agents; D007093:Imidazoles