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

Prospective Clinical Study, Using a Medical Device as an Adjuvant in the Treatment of Fungal (Candidiasis) and Bacterial Infections: Evaluation of the Safety and Efficacy of Rephegyn Vaginal Ovules

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bacterial Infections; Treatment of Fungal Infections, Candidiasis

• Study Type: Observational
• Enrollment (Estimated): 34

Contacts and Locations

• Study Contact: Name: Andrea Borgatta; Phone Number: +393472644870; Email: andreaborgatta@nextrasearch.it
• Study Contact Backup: Name: Ambrogio Frigerio, Medical doctor (gynecology); Phone Number: +39 02 994303352; Email: afrigerio@asst-rhodense.it

Study Locations

• Italy
  • Michigan
    • Garbagnate Milanese, Michigan, Italy, 20024
      • ASST Rhodense, Dipartimento di ginecologia e ostetricia, Viale Forlanini 95
      • Contact: Ambrogio Frigerio; Phone Number: +39 02 994303352; Email: afrigerio@asst-rhodense.it

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Female: form 18 - 75 years old

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• Patients receiving antibiotics, anti-inflammatory agents, analgesics, antineoplastic drugs, or immunosuppressants within 4 weeks prior to study inclusion
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Age between 18 and 75 years, female

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy: evaluation of pH	evaluation of pH with instrument for pH	"From enrollment to the end of treatment at 12 days (after menstrual cycle)
efficacy: VAS evaluation	The change from the semi-quantitative baseline score, expressed both for individual signs and symptoms and for their sum (total symptom VAS)	From enrollment to the end of treatment at 12 days (after menstrual cycle)
safety endpoint	The safety and tolerability of the treatments will be evaluated by investigating local and expected adverse events, as a consequence of the application of the product and any other adverse events occurring during the study.	From enrollment to the end of treatment at 12 days (after menstrual cycle)

Collaborators and Investigators

• Sponsor: Innate srl

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: candidiasis; bacterial infection; RepHegyn; pH restoring; barrier action
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Bacterial Infections; Candidiasis
• Other Study ID Numbers: MD 07b/2025/Rephe

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