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J Am Acad Dermatol. 2009 Dec;61(6):971-6. doi: 10.1016/j.jaad.2008.08.033. Epub 2009 Oct 13.

A double-blind, randomized, placebo-controlled, dose-finding study of oral pramiconazole in the treatment of pityriasis versicolor.

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1
Department of Dermatology, Sahlgrenska University Hospital, Göteborg, Sweden. jan.faergemann@derm.gu.se

Abstract

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.

PMID:
19828211
DOI:
10.1016/j.jaad.2008.08.033
[Indexed for MEDLINE]

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