One-week therapy with twice-daily butenafine 1% cream versus vehicle in the treatment of tinea pedis: a multicenter, double-blind trial.
BACKGROUND
Butenafine hydrochloride, a benzylamine derivative with potent antifungal activity, has been used in Japan to treat superficial fungal diseases.


OBJECTIVE
We evaluated the safety and efficacy of twice-daily butenafine versus its vehicle in the treatment of interdigital tinea pedis in a multicenter, randomized, double-blind, parallel-group trial.


METHODS
A total of 402 patients with interdigital tinea pedis and a positive potassium hydroxide examination were enrolled. Of the 271 patients who had culture-confirmed tinea pedis and were assessed for efficacy, 132 applied butenafine and 139 applied vehicle twice daily for 1 week. Patients were assessed for mycologic cure, effective treatment, overall cure, and mycologic/clinical cure.


RESULTS
The rates of all four end points were significantly higher with butenafine than with vehicle 5 weeks after treatment ended. Rates of mycologic cure and effective treatment with butenafine were significantly higher than with vehicle at cessation of treatment. Adverse events to treatment occurred in less than 1% of patients treated with butenafine and 2% of patients who applied vehicle.


CONCLUSIONS
Butenafine applied twice daily for 1 week is highly effective in treating interdigital tinea pedis.
Savin
R
R
Department of Dermatology, Yale University School of Medicine, New Haven, CT, USA.
De Villez
R L
RL
Elewski
B
B
Hong
S
S
Jones
T
T
Lowe
N
N
Lucky
A
A
Reyes
B
B
Stewart
D
D
Willis
I
I
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001596:Benzylamines / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D014008:Tinea Pedis / Q000188:drug therapy*; D016896:Treatment Outcome
D000935:Antifungal Agents; D001596:Benzylamines; D009281:Naphthalenes; C067594:butenafine