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

Primary Purpose

Vulvovaginal Candidiasis, Vaginal Yeast Infections

Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
JUVIA zinc containing vaginal gel treatment
Fluconazole 150Mg Tab
Sponsored by
FEMPHARMA Kft.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Candidiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Dr. Secret Private ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

JUVIA zinc-containing vaginal gel and Fluconazole

Fluconazole

Arm 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.

Control group. Receive oral fluconazole treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 15, 2023
Last Updated
June 12, 2023
Sponsor
FEMPHARMA Kft.
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1. Study Identification

Unique Protocol Identification Number
NCT05895162
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
January 7, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FEMPHARMA Kft.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Candidiasis, Vaginal Yeast Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JUVIA zinc-containing vaginal gel and Fluconazole
Arm Type
Experimental
Arm 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.
Arm Title
Fluconazole
Arm Type
Active Comparator
Arm Description
Control group. Receive oral fluconazole treatment.
Intervention Type
Drug
Intervention Name(s)
JUVIA zinc containing vaginal gel treatment
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Fluconazole 150Mg Tab
Intervention Description
Women receive oral fluconazole treatment with a single dose of oral fluconazole (150 mg).
Primary Outcome Measure Information:
Title
Clinical cure
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Time to initial symptom resolution.
Time Frame
12 weeks
Title
Vaginal fungal culture for Candida species.
Description
Proportion of negative vaginal fungal culture for Candida species.
Time Frame
12 weeks
Title
Clinical cure at days 28, 56, 84
Description
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).
Time Frame
12 weeks
Title
Candida severity score
Description
Minimum score: 0; maximum score: 18; higher score worse outcome.
Time Frame
12 weeks
Title
PRA-1 level
Time Frame
12 weeks
Title
CVL zinc level
Time Frame
12 weeks
Title
Vaginal pH
Time Frame
12 weeks
Title
Vaginal neutrophil count
Time Frame
12 weeks
Title
Concentration of calprotectin, IL-1beta, IL-8 in the vaginal sample by ELISA
Time Frame
12 weeks
Title
Vaginal measurement of CEF1, ACT1, PRA1, ECE1, HWP1, SAP6 expression by qRT-PCR
Time Frame
12 weeks
Title
Vulvovaginal symptoms questionnaire
Description
Minimum score: 0; maximum score: 21; higher scores indicates worse symptoms
Time Frame
12 weeks
Title
Vaginal Health Index
Description
Minimum score: 5; maximum score: 25; lower scores indicates worse symptoms
Time Frame
12 weeks
Title
Reported Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Szilvia Jager, PhD
Phone
0036 203926655
Email
szilvia.jager@fempharma.hu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bence Kozma, MD PhD
Organizational Affiliation
Dr. Secret Private Clinic Debrecen Hungary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Secret Private Clinic
City
Debrecen
State/Province
HB
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bence Kozma, MD PhD
Phone
0036 703263596
Email
bence.kozma@med.unideb.hu

12. IPD Sharing Statement

Learn more about this trial

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

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