Zinc-containing Vaginal Gel and Oral Fluconazole for Vulvovaginal Candidiasis.

Fempharma

Status: Enrolling

Conditions: Vaginal Yeast Infections; Vulvovaginal Candidiasis

Treatments: Drug: Fluconazole 150Mg Tab; Drug: JUVIA zinc containing vaginal gel treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05895162

2023VVC

Details and patient eligibility

About

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.

Full description

Randomized controlled trial will be conducted on 76 women with VVC, as confirmed by clinical and laboratory diagnosis. The participants will be allocated into two groups using blocked randomization method. In the control group participants will receive oral fluconazole treatment with a single dose of oral fluconazole (150 mg) while in the treatment group women will receive a single oral dose of fluconazole (150mg) followed by treatment with a zinc-containing vaginal gel (daily for 2 weeks and twice per week thereafter). Vaginal samples will be collected (vaginal swab and cervicovaginal lavage) at baseline and 4-8-12 weeks after starting treatment. In addition, the clinical signs and symptoms will be assessed before the intervention and follow-ups. Women will be asked to report any new symptoms of vaginal infections and will be asked to return for in-office evaluation.

Enrollment: 76 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

JUVIA zinc-containing vaginal gel and Fluconazole

Experimental group

Description:

JUVIA zinc containing vaginal gel group. Receive oral fluconazole treatment (150 mg) and after that participants will use a zinc containing- vaginal gel for 12 weeks.

Treatment:

Drug: JUVIA zinc containing vaginal gel treatment

Drug: Fluconazole 150Mg Tab

Fluconazole

Active Comparator group

Description:

Control group. Receive oral fluconazole treatment.

Treatment:

Drug: Fluconazole 150Mg Tab