Efficacy of a Single Oral Dose of 200 mg Pramiconazole in Vulvovaginal Yeast Infections: An Exploratory Phase IIa Trial
Gilbert Donders, Jannie Ausma, Luc Wouters, Geert Cauwenbergh, Marcel Borgers, Dirk Janssens
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¬vaginal yeast infection to confirm its efficacy and tolerability.