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

Vulvovaginal Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895162
• Other study ID #: 2023VVC
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2023
• Est. completion date: January 7, 2025

Study information

• Verified date: June 2023
• Source: FEMPHARMA Kft.
• Contact: Szilvia Jager, PhD
• Phone: 0036 203926655
• Email: szilvia.jager[@]fempharma.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: January 7, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis

Intervention

Drug:
• JUVIA zinc containing vaginal gel treatment
Women receive a single oral dose of fluconazole (150mg) followed by treatment with JUVIA zinc containing vaginal gel (daily for 2 weeks and twice per week thereafter).
• Fluconazole 150Mg Tab
Women receive oral fluconazole treatment with a single dose of oral fluconazole (150 mg).

Locations

Country	Name	City	State
Hungary	Dr. Secret Private Clinic	Debrecen	HB

Sponsors (1)

Lead Sponsor	Collaborator
FEMPHARMA Kft.

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure	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.	12 weeks
Secondary	Time to initial symptom resolution.		12 weeks
Secondary	Vaginal fungal culture for Candida species.	Proportion of negative vaginal fungal culture for Candida species.	12 weeks
Secondary	Clinical cure at days 28, 56, 84	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).	12 weeks
Secondary	Candida severity score	Minimum score: 0; maximum score: 18; higher score worse outcome.	12 weeks
Secondary	PRA-1 level		12 weeks
Secondary	CVL zinc level		12 weeks
Secondary	Vaginal pH		12 weeks
Secondary	Vaginal neutrophil count		12 weeks
Secondary	Concentration of calprotectin, IL-1beta, IL-8 in the vaginal sample by ELISA		12 weeks
Secondary	Vaginal measurement of CEF1, ACT1, PRA1, ECE1, HWP1, SAP6 expression by qRT-PCR		12 weeks
Secondary	Vulvovaginal symptoms questionnaire	Minimum score: 0; maximum score: 21; higher scores indicates worse symptoms	12 weeks
Secondary	Vaginal Health Index	Minimum score: 5; maximum score: 25; lower scores indicates worse symptoms	12 weeks
Secondary	Reported Adverse Events (AEs) and Serious Adverse Events (SAEs)		12 weeks