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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vulvovaginal Candidiasis; Vaginal Yeast Infections
• Intervention / Treatment: Drug: JUVIA zinc containing vaginal gel treatment; Drug: Fluconazole 150Mg Tab

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 Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Szilvia Jager, PhD; Phone Number: 0036 203926655; Email: szilvia.jager@fempharma.hu

Study Locations

• Hungary
  • HB
    • Debrecen, HB, Hungary, 4032
      • Recruiting
      • Dr. Secret Private Clinic
      • Contact: Bence Kozma, MD PhD; Phone Number: 0036 703263596; Email: bence.kozma@med.unideb.hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JUVIA zinc-containing vaginal gel and Fluconazole; 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.	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).; Drug: Fluconazole 150Mg Tab; Women receive oral fluconazole treatment with a single dose of oral fluconazole (150 mg).
Active Comparator: Fluconazole; Control group. Receive oral fluconazole treatment.	Drug: Fluconazole 150Mg Tab; Women receive oral fluconazole treatment with a single dose of oral fluconazole (150 mg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to initial symptom resolution.		12 weeks
Vaginal fungal culture for Candida species.	Proportion of negative vaginal fungal culture for Candida species.	12 weeks
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
Candida severity score	Minimum score: 0; maximum score: 18; higher score worse outcome.	12 weeks
PRA-1 level		12 weeks
CVL zinc 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
Vulvovaginal symptoms questionnaire	Minimum score: 0; maximum score: 21; higher scores indicates worse symptoms	12 weeks
Vaginal Health Index	Minimum score: 5; maximum score: 25; lower scores indicates worse symptoms	12 weeks
Reported Adverse Events (AEs) and Serious Adverse Events (SAEs)		12 weeks

Collaborators and Investigators

• Sponsor: FEMPHARMA Kft.
• Investigators: Principal Investigator: Bence Kozma, MD PhD, Dr. Secret Private Clinic Debrecen Hungary

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 7, 2025

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Candidiasis; Candidiasis, Vulvovaginal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluconazole
• Other Study ID Numbers: 2023VVC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No