Journal of the American Academy of Dermatology
Volume 61, Issue 6 , Pages 971-976, December 2009

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

  • Jan Faergemann, MD, PhD

      Affiliations

    • Department of Dermatology, Sahlgrenska University Hospital, Göteborg, Sweden
    • Corresponding Author InformationReprint requests: Jan Faergemann, MD, PhD, Barrier Therapeutics, Cipalstraat 3, B-2440 Geel, Belgium.
  • ,
  • Gail Todd, MBChB

      Affiliations

    • Groote Schuur Hospital, Observatory, Cape Town, South Africa
  • ,
  • Sandrakantha Pather, MBChB

      Affiliations

    • Skin Centre, University Cape Town, Lung Institute, Cape Town, South Africa
  • ,
  • Zubar F.A. Vawda, MBChB

      Affiliations

    • private practice, Durban, South Africa
  • ,
  • John D. Gillies, MBChB

      Affiliations

    • P3 Research Ltd, Tauranga, New Zealand
  • ,
  • Ted Walford, MBChB

      Affiliations

    • P3 Research Ltd, Tauranga, New Zealand
  • ,
  • Charles Barranco, BA

      Affiliations

    • Barrier Therapeutics Inc, Princeton, New Jersey
  • ,
  • John N. Quiring, PhD

      Affiliations

    • QST Consultations Ltd, Allendale, Michigan
  • ,
  • Manuel Briones, MD

      Affiliations

    • Francisco Bolonã, Guayaquil, Ecuador

Accepted 18 August 2008. published online 14 October 2009.

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

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 Supported by Barrier Therapeutics, Inc.

 Conflicts of interest: None declared.

PII: S0190-9622(08)01075-X

doi:10.1016/j.jaad.2008.08.033

Journal of the American Academy of Dermatology
Volume 61, Issue 6 , Pages 971-976, December 2009