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OpenTrials
Completed

NCT Number: NCT06392529

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

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.

Completed

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Beni-Suef University Teaching Hospital

Giza, Egypt

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Voriconazole Powder

Drug

The drug will be topically applied for vagina of patients suffering from vaginal Candidasis albican

Primary outcomes

  1. efficacy of nano voriconazole versus Clotrimazole in Treatment of vaginal candidiasis albicans and removal of symptoms

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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