Double-blind comparison of the efficacy, tolerance and safety of tioconazole and placebo in patients with vaginal candidiasis and the assessment of systemic absorption.

The results of studies are described which were designed to assess the efficacy, tolerance, and safety of tioconazole 2% cream administered once daily for 14 days in the treatment of vaginal candidiasis. One study was a double-blind comparison with vehicle cream and the other was an open efficacy study which additionally assessed the systemic absorption of tioconazole in 6 patients. In the double-blind study, 18 patients were treated with tioconazole and 17 with vehicle cream. In the tioconazole group, 12 of 17 patients (71%) were cured (complete clinical and mycologic resolution) at the 7-day review; at the end of treatment, 15 of 16 patients (94%) were cured, and at short-term follow-up (1 week after the end of treatment), 13 of 15 patients (87%) were cured. Of the latter 13 patients, 9 were reviewed at long-term follow-up and all (100%) remained cured. In the vehicle group, 4 of 17 patients (24%) were cured at the 7-day review; at the end of treatment only 3 of 6 patients (50%) were cured. At short-term follow-up, 2 of the 3 patients (67%) cured at the end of treatment remained cured. At long-term follow-up, 1 of the 2 cured at short-term follow-up was reviewed and she remained cured. In all, 13 of the 17 vehicle-treated patients were transferred to tioconazole treatment due to failure of the vehicle. Statistically, tioconazole treatment was significantly more effective than vehicle treatment. In the open part of this study, 11 of 11 patients were cured at the end of treatment. Follow-up reviews were not performed. A total of 6 patients took part in the study in which the systemic absorption of tioconazole was assessed. Bioassay of plasma samples revealed no detectable systemic absorption of tioconazole. No clinically relevant changes in laboratory test results were observed in either study. The creams were found to be generally acceptable in terms of ease of application, leakage from the vagina and staining of clothing.