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

NCT ID: NCT06392529

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-10

Study Completion Date

2024-06-30

Brief Summary

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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

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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

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Voriconazole Group

Voriconazole Powder

Intervention Type DRUG

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

Clotriamazole group

Voriconazole Powder

Intervention Type DRUG

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

Interventions

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Voriconazole Powder

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Raghda R.S. Hussein

Assistant Professor of Clinical Pharmacy and Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beni-Suef University Teaching Hospital

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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REC-H-PhBSU-24009

Identifier Type: -

Identifier Source: org_study_id

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