Randomized Controlled Trial to Assess the Effectiveness of a Zinc-containing Vaginal Gel and Fluconazole on Treatment and Recurrence of Vulvovaginal Candidiasis.

2023VVC

Vaginitis is one of the most common gynecological problems in women. Candida albicans is responsible for more than 85% of vaginal fungal infections and reinfection after standard treatment is quite common. The aim of this study is to compare the effects of a zinc-containing vaginal gel and oral fluconazole on the treatment and recurrence of vulvovaginal candidiasis (VVC). The investigator's hypothesis is that zinc-containing vaginal gel may decrease the rate of reinfection after standard treatment with oral 150 mg fluconazole.

2023-06-10

2024-12-31

2025-01-07

Recruiting

76

Inclusion Criteria: * Healthy, nonpregnant female participants aged ≥18 years with a clinical diagnosis of symptomatic acute VVC. * Positive baseline potassium hydroxide (KOH) wet mount from a vaginal smear revealing filamentous hyphae/pseudohyphae or budding yeast cells. * Presence of ≥1 vulvovaginal sign. * Presence of ≥1 vulvovaginal symptom. * Composite Candida severity score of ≥4. Exclusion Criteria: * Abnormal Papanicolaou smear in the preceding 12 months. * Patients who had oral or intravenous antifungal agents within 4 weeks, or used topical vaginal antifungal drugs within 1 week before the study. * Known human immunodeficiency virus infection, * Liver disease or abnormal liver function tests, lactation, pregnancy, and allergy to azole agents or zinc. * Women with non-albicans Candida species will be excluded from the final data analysis.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 76, 'type': 'ESTIMATED'}}

2023-06-13