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.

Limitations

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.

Abbreviations used: AE, adverse event, IGA, Investigator Global Assessment, KOH, potassium hydroxide