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.
Le texte complet de cet article est disponible en PDF.Abbreviations used : AE, IGA, KOH
Plan
| Supported by Barrier Therapeutics, Inc. |
|
| Conflicts of interest: None declared. |
Vol 61 - N° 6
P. 971-976 - décembre 2009 Retour au numéro
Article précédent
- Safety and tolerability of onabotulinumtoxinA in the treatment of facial lines: A meta-analysis of individual patient data from global clinical registration studies in 1678 participants
- Mitchell F. Brin, Terry I. Boodhoo, Janice M. Pogoda, Lynn M. James, George Demos, Yasunori Terashima, Juanhong Gu, Nina Eadie, Beta L. Bowen
- Treatment of subcutaneous phaeohyphomycosis and prospective follow-up of 17 kidney transplant recipients
- Marília Marufuji Ogawa, Nelson Zocoler Galante, Patrício Godoy, Olga Fischman-Gompertz, Flavia Martelli, Arnaldo Lopes Colombo, Jane Tomimori, José Osmar Medina-Pestana
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?