Clinical trial NCT05895162: Zinc-containing Vaginal Gel and Oral Fluconazole for Vulvovaginal Candidiasis.
Official title: Randomized Controlled Trial to Assess the Effectiveness of a Zinc-containing Vaginal Gel and Fluconazole on Treatment and Recurrence of Vulvovaginal Candidiasis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vulvovaginal Candidiasis
Vaginal Yeast Infections
Lead sponsor: FEMPHARMA Kft.
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical cure
timeFrame: 12 weeks
Secondary outcomes:
measure: Time to initial symptom resolution.
timeFrame: 12 weeks
measure: Vaginal fungal culture for Candida species.
timeFrame: 12 weeks
measure: Clinical cure at days 28, 56, 84
timeFrame: 12 weeks
measure: Candida severity score
timeFrame: 12 weeks
measure: PRA-1 level
timeFrame: 12 weeks
measure: CVL zinc level
timeFrame: 12 weeks
measure: Vaginal pH
timeFrame: 12 weeks
measure: Vaginal neutrophil count
timeFrame: 12 weeks
measure: Concentration of calprotectin, IL-1beta, IL-8 in the vaginal sample by ELISA
timeFrame: 12 weeks
measure: Vaginal measurement of CEF1, ACT1, PRA1, ECE1, HWP1, SAP6 expression by qRT-PCR
timeFrame: 12 weeks
measure: Vulvovaginal symptoms questionnaire
timeFrame: 12 weeks
measure: Vaginal Health Index
timeFrame: 12 weeks
measure: Reported Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Debrecen
country: Hungary
facility: Dr. Secret Private Clinic
state: HB
Study officials:
affiliation: Dr. Secret Private Clinic Debrecen Hungary
name: Bence Kozma, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: