[Usefulness of bifonazole for treatment of tinea pedis in the 20th year after approval].
We studied the usefulness of Mycospor Cream 1% (hereinafter referred to as "bifonazole cream"), which was approved 20 years ago in Japan, with once-daily application in 16 patients with tinea pedis (plantar tinea pedis, n = 8; interdigital tinea pedis, n = 8). One of them discontinued after 2 weeks of study treatment due to aggravation of skin symptoms. This subject was excluded from assessment of mycological activity and skin-symptom improvement at 4 weeks after initiation of treatment, but included in overall clinical efficacy rating and usefulness rating as an "ineffective" and "useless" case. The mean (+/- SD) duration of study treatment among the 15 subjects (excluding the discontinued subject) was 26.5 +/- 2.3 days (range: 21 to 28 days). The mycological eradication rate at Week 4 was 100% (15/15 subjects). The scores on all skin symptoms (itching, redness, papules, blisters, pustules, maceration, and scaling) at Week 4 significantly improved from the respective baseline scores (p<0.05), and almost all skin symptoms disappeared. The skin-symptom improvement rate was 93% (14/15 subjects). The overall clinical efficacy rate, which was assessed based on mycological efficacy and skin-symptom improvement rating, was 81% (13/16 subjects). No adverse reaction was observed in any of the subjects. The usefulness rate, which was assessed based on overall clinical efficacy and safety rating, was 88% (14/16 subjects). In this study, we confirmed that the usefulness of bifonazole cream for the treatment of tinea pedis was consistent with the results of studies performed before approval and 10 years after approval. About 20 years have passed since its launch, but bifonazole cream still remains a useful antifungal drug for topical treatment of tinea pedis.
Mitsui
Hiroshi
H
Department of Dermatology, Teikyo University School of Medicine.
Kanda
Naoko
N
Ohnishi
Takamitsu
T
Nakai
Kenji
K
Suzuki
Taku
T
Watanabe
Shinichi
S
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017277:Drug Approval; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D013997:Time Factors; D014008:Tinea Pedis / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
D000935:Antifungal Agents; D007093:Imidazoles; C036596:bifonazole