[Fundamental and clinical studies on the efficacy of bifonazole in patients with tinea pedis at 10 years after approval. Part 2. Clinical evaluation].
The usefulness of bifonazole (Mycospor), a topical imidazole antifungal agent approved 10 years ago, was evaluated for the treatment of tinea pedis. Mycospor cream was applied by 141 patients with tinea pedis once daily for 4 233ks, and the clinical efficacy and adverse reactions (as well as any correlations with susceptibility of isolates and the mycological activity of the agent against these isolates) were studied. The results were then compared to those of a previous study. The following results were obtained. 1. Mycological activity Mycological examination results became negative in 63.2% (36/57) of the patients with plantar tinea pedis, in 94.1% (32/34) of those with interdigital tinea pedis, and in 74.7% (68/91) of all tinea pedis patients. 2. Mycological activity and MIC No correlation was found between the MICs of bifonazole against the pathogenic fungi and the rate of eradication on mycological examination. 3. Improvement of symptoms The improvement rates for local symptoms were 82.5% for plantar tinea pedis, 85.7% for interdigital tinea pedis, and 83.7% for all tinea pedis. 4. Clinical efficacy Good clinical efficacies were found in 61.4% of the patients with plantar tinea pedis, in 88.6% of those with interdigital tinea pedis, and in 71.7% of all patients. 5. Safety Regarding adverse reactions, what seemed to be contact dermatitis was reported in 5 out of 127 cases (3.9%). The reaction decreased or disappeared in all cases. 6. Usefulness Mycospor was found to be useful in 64.9% of patients with plantar tinea pedis, in 88.6% of those with interdigital tinea pedis, and in 73.9% of all tinea pedis patients. 7. Comparison with former results The results obtained in the present clinical study were comparable to those obtained in patients with tinea pedis treated in a double-blind comparative study conducted during the development of as a new topical antifungal agent. From the above results, Mycospor cream was confirmed to be still useful, although it has been used widely for the topical treatment of cutaneous mycoses in the past 10 years since its approval.
Watanabe
S
S
Department of Dermatology, School of Medicine, Teikyo University.
Takahashi
H
H
Nakamura
Y
Y
Nakamura
E
E
Nishiyama
Y
Y
Teduka
M
M
Yamaguchi
H
H
Uchida
K
K
Tomizawa
T
T
Shimozuma
M
M
Osada
A
A
Kawano
S
S
Nakauchi
Y
Y
Wakukawa
M
M
Goto
A
A
Ueda
Y
Y
Matsukawa
A
A
Minami
H
H
Arikawa
J
J
Soma
Y
Y
Chi
H I
HI
Tamaki
K
K
D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000627:therapeutic use*; D004352:Drug Resistance, Microbial; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D014008:Tinea Pedis / Q000188:drug therapy* / Q000382:microbiology; D014249:Trichophyton / Q000187:drug effects / Q000302:isolation & purification
D000935:Antifungal Agents; D007093:Imidazoles; C036596:bifonazole