Efficacy of Voriconazole Loaded Spanlastics Gel Versus Clotriamazole Cream on Treating Vulvovaginal Candidasis

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Voriconazole Powder

• Registration Number: NCT06392529
• Lead Sponsor: Beni-Suef University

Brief 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.

Detailed 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 assesses

Study Timeline

• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-26
• Study First Posted: 2024-04-30
• Study Start: 2024-05-10
• Primary Completion: 2024-06-15
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Voriconazole Group	Voriconazole Powder	-
Clotriamazole group	Voriconazole Powder	-

Primary Outcome Measures

Name	Time	Method
efficacy of nano voriconazole versus Clotrimazole in Treatment of vaginal candidiasis albicans and removal of symptoms	1Month	To assess and compare the efficacy of nano voriconazole versus Clotrimazole in Treatment of vaginal candidiasis albicans in 3 and 5 days via smear cultures

Trial Locations

Locations (1)

Beni-Suef University Teaching Hospital; 🇪🇬 Giza, Egypt