A double-blind, randomized, placebo-controlled, dose-finding study of oral pramiconazole in the treatment of pityriasis versicolor.
BACKGROUND
Pramiconazole is a broad-spectrum triazole antifungal with potential for oral treatment of pityriasis versicolor.


OBJECTIVE
We sought to assess the efficacy and tolerability of 5 doses of pramiconazole relative to placebo.


METHODS
This was a randomized, multicenter, double-blind, placebo-controlled, 28-day, dose-finding study. A total of 147 patients were randomized to treatment with placebo or one of 5 doses of pramiconazole; treatment lasted for 3 consecutive days. Efficacy was based on mycological response, severity of clinical signs and symptoms, and the Investigator Global Assessment of lesion clearance.


RESULTS
A statistically significant (P < .001) dose-dependent effect was observed. When compared with placebo, a significant response (P < .05) was obtained for all but the lowest single dose of pramiconazole. There were no serious, treatment-related adverse events or other safety concerns.


CONCLUSIONS
The follow-up period was limited to 1 month after treatment onset.


CONCLUSIONS
Pramiconazole is a well-tolerated and effective treatment for pityriasis versicolor and the most effective treatment regimen in this study included 200 or 400 mg taken once, and 200 mg taken once daily for 2 or 3 days.
Faergemann
Jan
J
Department of Dermatology, Sahlgrenska University Hospital, Göteborg, Sweden. jan.faergemann@derm.gu.se
Todd
Gail
G
Pather
Sandrakantha
S
Vawda
Zubar F A
ZF
Gillies
John D
JD
Walford
Ted
T
Barranco
Charles
C
Quiring
John N
JN
Briones
Manuel
M
D000284:Administration, Oral; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D014010:Tinea Versicolor / Q000188:drug therapy*; D014230:Triazoles / Q000008:administration & dosage* / Q000009:adverse effects
D007093:Imidazoles; D014230:Triazoles; C482452:pramiconazole