CClinicalTrials.gg
Not yet recruitingNCT07367295Updated Apr 14, 2026

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

An observational study in Bacterial Infections and Treatment of Fungal Infections, Candidiasis, sponsored by Innate srl. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Innate srl · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
34
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Bacterial Infections
  • Treatment of Fungal Infections, Candidiasis

Keywords

  • candidiasis
  • bacterial infection
  • RepHegyn
  • pH restoring
  • barrier action
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Female: form 18 - 75 years old

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

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
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
34 participants (estimated)
Target follow-up
12 Days
Patient registry
Yes

Groups and cohorts

  • Age between 18 and 75 years, female
05

What researchers measure

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.

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

Secondary outcomes

  1. efficacy: evaluation of pH

    evaluation of pH with instrument for pH

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

  2. 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)

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

  3. 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.

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

06

Study locations

1 site
  • ASST Rhodense, Dipartimento di ginecologia e ostetricia, Viale Forlanini 95
    Garbagnate Milanese, Michigan 20024, Italy
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07367295
Lead sponsor
Innate srl
Responsible party
Sponsor
First posted
Jan 26, 2026
Start date
May 2026 (estimated)
Primary completion
May 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Apr 14, 2026

Study contacts

Ambrogio Frigerio, Medical doctor (gynecology)
Contact
afrigerio@asst-rhodense.it
+39 02 994303352
Andrea Borgatta
Contact
andreaborgatta@nextrasearch.it
+393472644870

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion