Evaluation of VagiVitalAC for Treatment of Candida Vulvovaginitis

A Two-part Study; Consisting of a Pilot Part Followed by a Randomized, Parallel Group Part; Comparing Topically Applied Novel Gel Containing Lactic Acid With no Treatment on Women With Candida Vulvovaginitis

Candidiasis is an infection caused by a yeast (a type of fungus) called Candida. Candidiasis in the vagina is commonly called a "vaginal yeast infection." Another names for this infection is "vaginal candidiasis". The symptoms of vaginal candidiasis include: Vaginal itching or soreness, Pain during sexual intercourse, Pain or discomfort when urinating and Abnormal vaginal discharge. VagiVitalAC is a modified version of the existing gel VagiVital, formulated to act as a treatment for fungal infections.

This clinical investigation is a two-part study consisting of a pilot part followed by a randomized part. The aim of the pilot part is to evaluate if VagiVitalAC is able to cure the vulvovaginal candidiasis in at least 70% of the patients after 7 days treatment. If the proportion of cured patients is at least 70 %, the next part, the randomized part, will be performed. In the randomized part, the treatment efficacy and safety of VagiVitalAC on candida vulvovaginitis will be evaluated by comparing a treatment group with a control group receiving no treatment.

Study Overview

• Status: Recruiting
• Conditions: Vaginal Candidiasis; Candidal Vulvovaginitis; Vulvovaginal Candidiasis
• Intervention / Treatment: Device: VagiVitalAC

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan Markusson; Phone Number: +46104750800; Email: registrator@etikprovning.se

Study Locations

• Sweden
  • Huddinge, Sweden
    • Recruiting
    • Karolinska University Hospital
    • Contact: Aino Fianu Jonasson, MD, PhD
    • Principal Investigator: Aino Fianu Jonasson, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Be a female, 18 years or older.
• Signed informed consent form.
• Women with earlier recurrent verified vaginal candidiasis.
• Has seeked treatment for suspected fungal infection.
• Be judged by an investigator as having an ongoing vulvovaginal candidiasis.
• If of child-bearing potential, willing to use a reliable method of contraception during the duration of the study. The following methods of contraception are considered reliable: an intrauterine device or any of the following hormonal contraceptives: contraceptive pills, implants, transdermal patches, vaginal ring, injections with prolonged release. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
• Be in general good health, as judged by an investigator.

Exclusion Criteria:

• Be currently hospitalized.
• First time with a vulvovaginal candidiasis infection.
• Have a history of ongoing cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, or musculoskeletal disease or disorder that is clinically significant in the opinion of the Principal Investigator or Sub-Investigator.
• Have a history of undiagnosed vaginal bleeding.
• Have an ongoing urogenital infection at the screening visit, other than vulvovaginal candidiasis.
• Any contraindication to the gel (VagiVitalAC) therapy and allergy to the use of any components of the investigational device.
• Pregnant, as determined by urine pregnancy test.
• Have been giving birth during the last 30 days.
• Have a history of drug and/or alcohol abuse within one year of start of study.
• Patient who are currently menstruating or anticipate they will start menstruating within 7 days of starting using the investigational device.
• Have used any intravaginal or systemic antifungal medication within the previous 7 days or had used any intravaginal product such as a spermicide, medicated douche or feminine spray within two days before the start of the study.
• Current treatment for any medical condition that include systemic antimycotics or immunosuppressive drugs.
• Have any reason, which in the opinion of the Principal Investigator would prevent the patient from safely participating in the study or complying with protocol requirements.
• Have participated in another clinical trial within 30 days prior to screening, have received an investigational drug within one month prior to the initial dose of the investigational medical device, or be likely to participate in another clinical trial or receive another investigational medication during the study.

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
No Intervention: No treatment
Experimental: VagiVitalAC	Device: VagiVitalAC; In the Pilot part, the single intervention used is VagiVitalAC treatment for 30 days. In the randomized part, patients in the Interventional arm are treated with VagiVital AC for up to 90 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence or not of candida fungi in the vaginal culture after 7 days treatment	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or not of candida fungi in the vaginal culture after 30 days treatment		Day 30
For patients with initial treatment effect (i.e., no presence of candida fungi in the vaginal culture) after 7 days treatment, relapse at day 30, after continued treatment		Day 30
Change in self-reported vulvovaginal symptoms (vaginal itching/burning and/or soreness and/or vaginal discharge and/or pain during sexual intercourse) after 7 days treatment compared to baseline (patient's own experience)		Day 7
Change in self-reported vulvovaginal symptoms after 7 days treatment compared with baseline (patient's own experience), that has been self-identified by the patient as being the most bothersome to her		Day 7
Change in self-reported vulvovaginal symptoms (vaginal itching/burning and/or soreness and/or vaginal discharge and/or pain during sexual intercourse) after 30 days treatment compared to baseline (patient's own experience)		Day 30
Change in self-reported vulvovaginal symptoms after 30 days treatment (patient's own experience), that has been self-identified by the patient at baseline as being the most bothersome to her		Day 30
Frequency of Adverse events Adverse Events (AEs)/Serious Adverse Events (SAEs)/Device Deficiencies (DDs)/Adverse Device Effects (ADEs)/Serious Adverse Device Effects (SADEs) at 7 days		Day 7
Frequency of Adverse events AEs/SAEs/DDs/ADEs/SADEs at 30 days		Day 30
Presence or not of candida fungi in the vaginal culture after 90 days treatment.	Only applicable for randomized part	Day 90
For patients with initial treatment effect by VagiVitalAC (i.e. no presence of candida fungi in the vaginal culture) after 7 and 30 days treatment, relapse at day 90, after continued treatment.	Only applicable for randomized part	Day 90
Change in self-reported vulvovaginal symptoms after 7 days treatment compared to baseline, Investigational device group compared to comparator group (patient's own experience).	Only applicable for randomized part	Day 7
Change in self-reported vulvovaginal symptoms after 7 days treatment, Investigational device group compared to comparator group (patient's own experience), that has been self-identified by the patient at baseline as being the most bothersome to her.	Only applicable for randomized part	Day 7
Change in self-reported vulvovaginal symptoms (vaginal itching/burning and/or soreness and/or vaginal discharge and/or pain during sexual intercourse) after 90 days treatment compared to baseline (patient's own experience).	Only applicable for randomized part	Day 90
Change in self-reported vulvovaginal symptoms after 90 days treatment (patient's own experience), that has been self-identified by the patient at baseline as being the most bothersome to her.	Only applicable for randomized part	Day 90
Frequency of Adverse events AEs/SAEs/DDs/ADEs/SADEs at 7 days, Investigational device group compared to comparator group	Only applicable for randomized part	Day 7
Frequency of Adverse events AEs/SAEs/DDs/ADEs/SADEs at 90 days.	Only applicable for randomized part	Day 90

Collaborators and Investigators

• Sponsor: PepTonic Medical AB
• Collaborators: StatCons; Karolinska Trial Alliance
• Investigators: Principal Investigator: Aino Fianu Jonasson, MD, PhD, Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Candidiasis; Vulvovaginitis; Candidiasis, Vulvovaginal
• Other Study ID Numbers: VagiPep102; CIV-21-06-037087 (Registry Identifier: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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