NCT06392529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

May 10, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

1 month

First QC Date

April 26, 2024

Last Update Submit

August 5, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

    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

    1Month

Study Arms (2)

Voriconazole Group

Drug: Voriconazole Powder

Clotriamazole group

Drug: Voriconazole Powder

Interventions

Voriconazole PowderDRUG

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

Clotriamazole groupVoriconazole Group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Female patients suffering from vulvovaginal candidiasis albicans

You may qualify if:

  • Female patients aging from 20 t0 40 years old suffering from vulvovaginal candidiasis caused by albicans species.

You may not qualify if:

  • Pregnant women, female suffering from vulvovaginal candidiasis caused by other species rather than C. albicans.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Suef University Teaching Hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Pharmacy and Head of Department

Study Record Dates

First Submitted

April 26, 2024

First Posted

April 30, 2024

Study Start

May 10, 2024

Primary Completion

June 15, 2024

Study Completion

June 30, 2024

Last Updated

August 7, 2024

Record last verified: 2024-08

Locations

EG(1)