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Clinical Trial Summary

To investigate and compare the efficacy of voriconazole loaded spanlastics (VCZ loaded SPs) optimum gel formula (F2 VCZ loaded SP gel) versus Clotrimazole cream in treating candida albicans causing vulvovaginal candidiasis for different durations of 3 days and 5 days.


Clinical Trial Description

The current study will be prospective controlled randomized clinical trial. 28 female patients suffering from vulvovaginal candidiasis will be enrolled in the following 2 groups: Gp 1 (Test group): including 14 patients with vulvovaginal candidiasis albicans that will be randomized in the following subgroups: Gp 1a: will be treated with F2 VCZ loaded SP gel for 3 days. Gp 1 b: Will be treated with F2 VCZ loaded SP gel for 5 days. Gp 2 (Control group): including 14 patients with vulvovaginal candidiasis albicans will be randomized in the following sub groups Gp 2 a: will be treated with the Clotrimazole cream available in the market for 3 days. Gp 2 b: Will be treated with the Clotrimazole cream available in the market for 5 days. Smears will be taken from the patients before starting the therapeutic protocol and after finishing it. Compliance of the patients to the creams will be assessed. Inclusion Criteria: Female patients aging from 20 t0 40 years old suffering from vulvovaginal candidiasis caused by albicans species. Exclusion Criteria: Pregnant women, female suffering from vulvovaginal candidiasis caused by other species rather than C. albicans. ;


Study Design


NCT number NCT06392529
Study type Observational
Source Beni-Suef University
Contact Raghda Hussein, Assistant Professor
Phone 00201010647666
Email Raghda.hussien@pharm.bsu.edu.eg
Status Recruiting
Phase
Start date April 28, 2024
Completion date May 30, 2024