Back to resultsa Flexible Wound Dressing for the Management of Genital Skin Conditions
Primary Purpose
Vaginitis, Atrophic Vaginitis, Lichen Planus
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Film forming silicone gel (7-0940)
Sponsored by
About this trial
This is an interventional treatment trial for Vaginitis
Eligibility Criteria
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
Sites / Locations
- St. Andrews War Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment arm
Arm Description
Film forming silicone gel (7-0940) is an innovative gel that forms a full contact, flexible wound dressing for supporting mucosal conditions of the genital, rectal and perineal areas. Film forming silicone gel (7-0940) is a semi-occlusive, non-resorbable, self-drying and transparent gel. Film forming silicone gel (7-0940) may be directly applied to dry, wet, cracked and sensitive mucosal tissue. Film forming silicone gel (7-0940) gel is bacteriostatic and inert. It contains no alcohols, parabens or fragrances.
Outcomes
Primary Outcome Measures
gynaecological skin condition
Likert scales to measure:
Dryness
Tissue thinning
Erosion/Ulcers
Fissures
Erythema
Scarring/adhesion
Contact bleeding
Bloodblisters
Greyish film
White lacy streaks
Secondary Outcome Measures
patient symptoms
Likert scales to measure:
Pruritus/itchiness
Tender/sore
Swelling
Dryness
Burning of skin
Dyspareunia
Stinging with urination/clothes
Defecating pain/burning
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05396261
Brief Title
a Flexible Wound Dressing for the Management of Genital Skin Conditions
Official Title
Post-marketing Surveillance of a Flexible Wound Dressing for the Management of Genital Skin Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stratpharma AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginitis, Atrophic Vaginitis, Lichen Planus, Lichen Sclerosus, Menopause Related Conditions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
Film forming silicone gel (7-0940) is an innovative gel that forms a full contact, flexible wound dressing for supporting mucosal conditions of the genital, rectal and perineal areas.
Film forming silicone gel (7-0940) is a semi-occlusive, non-resorbable, self-drying and transparent gel.
Film forming silicone gel (7-0940) may be directly applied to dry, wet, cracked and sensitive mucosal tissue.
Film forming silicone gel (7-0940) gel is bacteriostatic and inert. It contains no alcohols, parabens or fragrances.
Intervention Type
Device
Intervention Name(s)
Film forming silicone gel (7-0940)
Intervention Description
Anecdotal evidence suggests that genital conditions in women associated with vaginal atrophy improve with the use of film-forming silicone dressings.
Primary Outcome Measure Information:
Title
gynaecological skin condition
Description
Likert scales to measure:
Dryness
Tissue thinning
Erosion/Ulcers
Fissures
Erythema
Scarring/adhesion
Contact bleeding
Bloodblisters
Greyish film
White lacy streaks
Time Frame
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
Secondary Outcome Measure Information:
Title
patient symptoms
Description
Likert scales to measure:
Pruritus/itchiness
Tender/sore
Swelling
Dryness
Burning of skin
Dyspareunia
Stinging with urination/clothes
Defecating pain/burning
Time Frame
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
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Hall, MD
Organizational Affiliation
St. Andrews War Memorial Hospital - Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Andrews War Memorial Hospital
City
Spring Hill
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
a Flexible Wound Dressing for the Management of Genital Skin Conditions
We'll reach out to this number within 24 hrs