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
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.
Female: form 18 - 75 years old
Exclusion Criteria:
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)
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)
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)
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)
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Innate srl