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

Not Applicable

Recruiting

• Conditions: Vaginal Yeast Infections; Vulvovaginal Candidiasis
• Interventions: Drug: JUVIA zinc containing vaginal gel treatment; Drug: Fluconazole 150Mg Tab

• Registration Number: NCT05895162
• Lead Sponsor: FEMPHARMA Kft.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-15
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-08
• Study Start: 2023-06-10
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-13
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JUVIA zinc-containing vaginal gel and Fluconazole	JUVIA zinc containing vaginal gel treatment	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.
JUVIA zinc-containing vaginal gel and Fluconazole	Fluconazole 150Mg Tab	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.
Fluconazole	Fluconazole 150Mg Tab	Control group. Receive oral fluconazole treatment.

Primary Outcome Measures

Name	Time	Method
Clinical cure	12 weeks	The proportion of participants with clinical cure throughout the study period. Clinical cure is defined as follows: complete resolution of signs and symptoms pertaining to VVC and no new sign or symptom of VVC during the follow-up period.

Secondary Outcome Measures

Name	Time	Method
Vaginal fungal culture for Candida species.	12 weeks	Proportion of negative vaginal fungal culture for Candida species.
Clinical cure at days 28, 56, 84	12 weeks	The proportion of participants with clinical cure at days 28, 56, 84. Clinical cure is defined as follows: complete resolution of signs and symptoms pertaining to VVC and no new sign or symptom of VVC during the follow-up period (at days 28, 56, 84).
CVL zinc level	12 weeks
Time to initial symptom resolution.	12 weeks
Candida severity score	12 weeks	Minimum score: 0; maximum score: 18; higher score worse outcome.
PRA-1 level	12 weeks
Vaginal pH	12 weeks
Vaginal neutrophil count	12 weeks
Concentration of calprotectin, IL-1beta, IL-8 in the vaginal sample by ELISA	12 weeks
Vaginal measurement of CEF1, ACT1, PRA1, ECE1, HWP1, SAP6 expression by qRT-PCR	12 weeks
Vaginal Health Index	12 weeks	Minimum score: 5; maximum score: 25; lower scores indicates worse symptoms
Reported Adverse Events (AEs) and Serious Adverse Events (SAEs)	12 weeks
Vulvovaginal symptoms questionnaire	12 weeks	Minimum score: 0; maximum score: 21; higher scores indicates worse symptoms

Trial Locations

Locations (1)

Dr. Secret Private Clinic; 🇭🇺 Debrecen, HB, Hungary