To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Investigative Pramiconazole Effective for Treating Pityriasis Versicolor: Presented at AAD URL: http://www.pslgroup.com/dg/21C9D6.htm Doctor's Guide February 7, 2008
By Bruce Sylvester SAN ANTONIO, TX -- February 7, 2008 -- Pramiconazole, a novel oral antifungal agent, is effective for treatment of pityriasis versicolor, researchers reported at the American Academy of Dermatology 66th Annual Meeting (AAD). The phase 2, dose-finding study results were highlighted and presented at a poster session on February 4. "We saw an 84% response at 200 mg twice daily dosing, which was statistically significantly different from placebo," said presenter and lead investigator Jan Faergemann, MD, PhD, Professor of Dermatology, University of Gothenberg, Gothenberg, Sweden. "All does of pramiconazole, with the exception of 100 mg once daily, achieved significant efficacy compared to placebo, and we saw a linear dose response with increasing dosing," he added. Pramiconazole is a novel, oral, broad spectrum antifungal agent that inhibits the biosynthesis of ergosterol in the fungal plasma membrane. Pityriasis versicolor is a common, superficial cutaneous fungal infection characterised by dyspigmented macules and patches on the upper trunk and arms. The study was multicentre, randomised, double-blind and placebo controlled. Investigators enrolled 147 adult patients with clinically evident, potassium hydroxide (KOH) positive pityriasis versicolor. They administered pramiconazole for three consecutive days as follows: placebo; 100 mg once daily; 200 mg once daily; 400 mg once daily. In the 200-mg arm, one subgroup received 200 mg once daily for 2 days and placebo on day 3, and the other subgroup received 200 mg daily for all 3 days. Clinical assessments took place at days 14 and 28, and they included evaluations for signs and symptoms of disease, a global assessment of disease activity, and a mycological exam with potassium hydroxide (KOH) preparation. The primary endpoint for efficacy was the proportion of subjects achieving negative KOH concurrent with complete resolution of erythema, desquamation, and pruritus, or minimal residual signs and symptoms if the baseline evaluations were moderate or severe. At day 28, the trend in the success rate was statistically significant (P </=.001), indicating a linear dose response, the researchers reported. They also reported a statistically significant (P </=.003) response among subjects using pramiconazole 200 mg once daily (n=13, 59%), 400 mg once daily (n=16, 70%), 200 mg daily for 2 days (n=21, 84%), and 200 mg daily for 3 days (n= 22, 85%), compared with placebo (n =4, 16%). The most commonly reported treatment-related adverse event was diarrhoea (overall 24%), which the researchers attributed to a component of the drug formulation. Two serious adverse events occurred, but they were not related to pramiconazole treatment. The authors concluded, "Brief regimens of oral pramiconazole, at doses of 200 mg once, 400 mg once, 200 mg daily for 2 days, and 200 mg daily for 3 days were well tolerated and effective in the treatment of patients with pityriasis versicolor." "Further clinical study of pramiconazole for the treatment of cutaneous fungal infections is warranted," they stated. Funding for this study was provided by Barrier Therapeutics [Presentation title: Pramiconazole, a Novel Oral Antifungal Agent, Effectively Treats Pityriasis Versicolor: Results of a Dose-Finding Clinical Study. Poster 1704] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.