An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis
Not Applicable
Completed
- Conditions
- Atrophic Vaginitis
- Interventions
- Device: Film forming silicone gel (7-0940)
- Registration Number
- NCT05432154
- Lead Sponsor
- Stratpharma AG
- Brief Summary
The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10
Inclusion Criteria
- Able to provide informed consent
- Diagnosed acute or chronic Atrophic Vaginitis
- Controlled disease, or uncontrolled disease that did not respond to standard therapy with HRT
Exclusion Criteria
- Unable to provide informed consent
- Patient unable to apply topical device
- Allergy or intolerance to ingredients or excipients of the formulation of studied products
- Currently on HRT (orally or topically)
- Currently on corticosteroid treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment arm Film forming silicone gel (7-0940) Patients apply 7-0940 at least 2 times daily for 3 months.
- Primary Outcome Measures
Name Time Method Patient-reported Vulvar Quality of Life 3 months Vulvar Quality of Life Index
- Secondary Outcome Measures
Name Time Method Severity of overall condition 3 months Clinician-rated severity of atrophic vaginitis
Patient-reported symptoms 3 months Likert scales to measure:
* Pruritus/itchiness
* Tender/sore
* Swelling
* Dryness
* Burning of skin
* Dyspareunia
* Stinging with urination/clothes
* Defecating pain/burningProduct rating 3 months Likert scale for product rating by the patient
Trial Locations
- Locations (1)
Orange Coast Women's Medical Group
🇺🇸Laguna Hills, California, United States