a Flexible Wound Dressing for the Management of Genital Skin Conditions
Not Applicable
Completed
- Conditions
- Atrophic VaginitisLichen PlanusMenopause Related ConditionsVaginitisLichen Sclerosus
- Registration Number
- NCT05396261
- Lead Sponsor
- Stratpharma AG
- Brief Summary
The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 54
Inclusion Criteria
- Able to provide informed consent
- Diagnosed genital skin condition
Exclusion Criteria
- Unable to give informed consent
- Patient unable to apply topical device
- Allergy or intolerance to ingredients or excipients of the formulation of studied products
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method gynaecological skin condition Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months Likert scales to measure:
* Dryness
* Tissue thinning
* Erosion/Ulcers
* Fissures
* Erythema
* Scarring/adhesion
* Contact bleeding
* Bloodblisters
* Greyish film
* White lacy streaks
- Secondary Outcome Measures
Name Time Method patient symptoms Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months Likert scales to measure:
* Pruritus/itchiness
* Tender/sore
* Swelling
* Dryness
* Burning of skin
* Dyspareunia
* Stinging with urination/clothes
* Defecating pain/burning
Trial Locations
- Locations (1)
St. Andrews War Memorial Hospital
🇦🇺Spring Hill, Queensland, Australia
St. Andrews War Memorial Hospital🇦🇺Spring Hill, Queensland, Australia