Efficacy of a single oral dose of 200 mg pramiconazole in vulvovaginal yeast infections: an exploratory phase IIa trial.

Pramiconazole (R126638) is a novel azole with potent antifungal activity against yeasts, dermatophytes and many other fungal species. The aim of this study was to evaluate the efficacy and tolerance of a single oral dose of 200 mg pramiconazole in acute and recurrent vulvovaginal yeast infections. Thirty-two patients (15 acute and 17 recurrent cases) were KOH microscopy- and culture-positive at inclusion. Clinical cure was 53% at one week and 66% at one month. Mycological eradication was obtained in 88% at one week, whereas at one month 75% of the patients were still culture-negative. Effects in both acute and recurrent cases appeared to be similar for mycological cure. The composite sign and symptom score (sum of scores for oedema, erythema, excoriation pruritus, burning and irritation) had a median value of 7.5 (range 2-17) at inclusion. At one week this value was reduced to 1.0 (range 0-8) and at one month a further reduction to 0 (range 0-11) was seen. p-values compared with baseline at both follow-up visits were <0.001. The drug was well tolerated and the reported adverse events were rare and minimal. In conclusion, the results of this trial indicate that pramiconazole possesses properties that warrant further clinical studies in a larger number of patients with acute and recurrent vulvo notvaginal yeast infection to confirm its efficacy and tolerability.

[1]  J. Ausma,et al.  The efficacy of oral treatment with pramiconazole in tinea pedis and tinea cruris/corporis: two exploratory phase IIa trials , 2008, The British journal of dermatology.

[2]  J. Ausma,et al.  The efficacy of oral treatment with pramiconazole in pityriasis versicolor: a phase II a trial , 2007, The British journal of dermatology.

[3]  J. Heeres,et al.  Antifungal azoles for skin disorders , 2006 .

[4]  J. Heeres,et al.  Synthesis and in vitro and in vivo structure-activity relationships of novel antifungal triazoles for dermatology. , 2005, Journal of medicinal chemistry.

[5]  C. Evrüke,et al.  Clinical and mycological efficacy of single‐day oral treatment with itraconazole (400 mg) in acute vulvovaginal candidosis , 2004, Mycoses.

[6]  L. Meerpoel,et al.  The Novel Azole R126638 Is a Selective Inhibitor of Ergosterol Synthesis in Candida albicans, Trichophyton spp., and Microsporum canis , 2004, Antimicrobial Agents and Chemotherapy.

[7]  J. Heeres,et al.  In Vitro and In Vivo Activities of the Novel Azole Antifungal Agent R126638 , 2004, Antimicrobial Agents and Chemotherapy.

[8]  J. Heeres,et al.  In Vitro and In Vivo Activities of the Novel Azole Antifungal Agent R 126638 , 2004 .

[9]  C. Nappi,et al.  Fluconazole 150 mg single dose versus itraconazole 200 mg per day for 3 days in the treatment of acute vaginal candidiasis: a double-blind randomized study. , 2003, European journal of obstetrics, gynecology, and reproductive biology.

[10]  J. Sobel.  Treatment of vaginal Candida infections , 2002, Expert opinion on pharmacotherapy.

[11]  S. Higgins,et al.  Comparison of clotrimazole, fluconazole and itraconazole in vaginal candidiasis. , 1995, The British journal of clinical practice.

[12]  J. Tobin,et al.  Treatment of vaginal candidosis: a comparative study of the efficacy and acceptability of itraconazole and clotrimazole. , 1992, Genitourinary medicine.

[13]  V. Yule.  Treatment options : a patient's viewpoint. Findings from a Pan-European survey , 1992 .

[14]  S. Wesel.  Itraconazole: a single-day oral treatment for acute vulvovaginal candidosis. , 1990, British journal of clinical practice. Supplement.

[15]  M. Borgers,et al.  The effect of ketoconazole and itraconazole on the filamentous form of Pityrosporum ovale. , 1990, Acta Dermato-Venereologica.

[16]  F. Sanz,et al.  Randomized Comparative Trial of Three Regimens of Itraconazole for Treatment of Vaginal Mycoses , 1987 .