A double-blind, randomized, placebo-controlled, dose-finding study of oral pramiconazole in the treatment of pityriasis versicolor - 24/08/11
, Gail Todd, MBChB b, Sandrakantha Pather, MBChB c, Zubar F.A. Vawda, MBChB d, John D. Gillies, MBChB e, Ted Walford, MBChB e, Charles Barranco, BA f, John N. Quiring, PhD g, Manuel Briones, MD h
Reprint requests: Jan Faergemann, MD, PhD, Barrier Therapeutics, Cipalstraat 3, B-2440 Geel, Belgium.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.
Il testo completo di questo articolo è disponibile in PDF.Abbreviations used : AE, IGA, KOH
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| Supported by Barrier Therapeutics, Inc. |
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| Conflicts of interest: None declared. |
Vol 61 - N° 6
P. 971-976 - dicembre 2009 Ritorno al numero
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