Prospective Clinical Study, Using a Medical Device (RepHegyn) as an Adjuvant in the Treatment of Fungal (Candidiasis) and Bacterial Infections

NCT07367295 | Not Yet Recruiting

• 1 other identifier: MD 07b/2025/Rephe
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The medical device It is indicated to promote the re-epithelialization processes of the vaginal mucosa, in the prevention of vaginal conditions of bacterial and fungal origin, and as an adjuvant in their treatment. The primary efficacy endpoint is based on the VAS symptom score (abnormal vaginal discharge, lower abdominal pain, dysuria, burning micturition, dyspareunia, vulvar irritation, and itching on a 10-point scale), specifically the percentage of patients with therapeutic success, defined as resolution of signs and symptoms of recurrent bacterial and fungal infections (total symptom score \<2) at the end of treatment.

Conditions

Bacterial Infections; Treatment of Fungal Infections, Candidiasis

Keywords

candidiasis; bacterial infection; RepHegyn; pH restoring; barrier action

Outcome Measures

Primary Outcomes (1)

• efficacy endpoint: VAS score for symptoms

  The primary efficacy endpoint is based on the VAS score for symptoms (abnormal vaginal discharge, lower abdominal pain, dysuria, burning micturition, dyspareunia, vulvar irritation, and itching on a 10-point scale), specifically the percentage of patients with therapeutic success, defined as resolution of signs and symptoms of recurrent bacterial and fungal infections (total symptom score \<2) at the end of treatment reported below.

  "From enrollment to the end of treatment at 12 days (evaluation after menstrual cycle)

Secondary Outcomes (3)

• efficacy: evaluation of pH

  "From enrollment to the end of treatment at 12 days (after menstrual cycle)

• efficacy: VAS evaluation

  From enrollment to the end of treatment at 12 days (after menstrual cycle)

• safety endpoint

  From enrollment to the end of treatment at 12 days (after menstrual cycle)

Study Arms (1)

Age between 18 and 75 years, female

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female: form 18 - 75 years old

You may qualify if:

• Age between 18 and 75 years
• Signed written informed consent.
• At least two subjective symptoms and two objective signs (at least moderate) of vaginal inflammation due to infection. Vaginal inflammation will be assessed based on six subjective symptoms (burning, pain, itching, irritation, dyspareunia, and dysuria) and four objective signs (swelling, vaginal discharge typical of the infection, pH, and presence of abrasion/erosion).
• Confirmed recurrent bacterial vaginosis and candidiasis.
• Patient able to maintain a patient diary during the study.
• Patient is able to read and understand the language and content of the study materials, understands the requirements for follow-up visits, is willing to provide information at scheduled assessments, and is willing and able to comply with study requirements.

You may not qualify if:

• Patients who do not sign the informed consent form
• Other gynecological diseases, immunosuppressive diseases (e.g., HIV infection), or who are immunocompromised for reasons such as corticosteroid therapy, chemotherapy, anti-angiogenic agents, or immunosuppressants, patients with diabetes
• History of connective tissue diseases, e.g., systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, or mixed connective tissue disease
• Known allergy to any component of the device
• Subjects unable to understand the informed consent form or who have a high likelihood of non-compliance with study procedures and/or non-completion of the study according to the investigator's judgment
• Pregnancy and breastfeeding
• Time between the last day of the last menstrual period and the baseline visit \>16 days or ≤5 days (for non-menopausal subjects).
• Participation in other clinical studies

Sponsors & Collaborators

• Innate srl: lead

Study Sites (1)

ASST Rhodense, Dipartimento di ginecologia e ostetricia, Viale Forlanini 95

Garbagnate Milanese, Michigan, 20024, Italy

Location

MeSH Terms

Conditions

Bacterial Infections; Candidiasis

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Mycoses

Central Study Contacts

Ambrogio Frigerio, Medical doctor (gynecology)

CONTACT

+39 02 994303352; afrigerio@asst-rhodense.it

Andrea Borgatta

CONTACT

+393472644870; andreaborgatta@nextrasearch.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 26, 2026
• Study Start: May 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)