Topical treatment of vaginal candidosis with sertaconazole and econazole sustained-release suppositories.

OBJECTIVE

To compare the efficacy and safety of sertaconazole and econazole sustained-release suppositories in the treatment of vulvovaginal candidosis.

STUDY DESIGN

369 women with symptoms and signs of vulvovaginitis were enrolled in this multicenter, randomized, double-blind study. After clinical examination and vaginal sampling, 183 women were treated with a 300-mg sertaconazole suppository and the other 186 with a 150-mg econazole suppository. They were evaluated 1 week after treatment and those who were clinically uncured received a second suppository and were re-assessed 1 week later. All women were evaluated 1 month after the last administration. At each follow-up visit, clinical efficacy was assessed and a vaginal sampling was performed for microscopic examination and culture.

RESULTS

Of the 369 women included, only the 310 who had a positive culture for a strain of Candida were taken into account for efficacy analysis: 150 in the sertaconazole group and 160 in the econazole group. One hundred and five women (49 in the sertaconazole group and 56 in the econazole group) were not clinically cured after 1 week and received a second suppository. There were no differences between the two groups for the rates of clinical recovery (disappearance of signs and symptoms) and mycological recovery (negative culture), 1 week after the first application (62.1 and 67.7%, respectively), 1 week after the second application for women treated twice (72.3 and 80.6%, respectively) and for all patients 1 month after the last application (65.3 and 62.0%, respectively). Among the patients cured 1 week after the last application, the mycological recurrence rate after 1 month was significantly higher in the econazole group (32.7 vs. 19.8%, P=0.035). There was a trend towards better efficacy of sertaconazole after the first application, whereas the two treatments had similar efficacy in women treated twice. There were no serious adverse events and only local irritation was reported, without any statistically significant difference between the two groups.

CONCLUSION

Single topical administration of sertaconazole and econazole had similar efficacy and safety but the former is associated with a lower rate of mycological recurrence one month after achieving a negative culture.