An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis
Primary Purpose
Atrophic Vaginitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Film forming silicone gel (7-0940)
Sponsored by
About this trial
This is an interventional treatment trial for Atrophic Vaginitis
Eligibility Criteria
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
Sites / Locations
- Orange Coast Women's Medical Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment arm
Arm Description
Patients apply 7-0940 at least 2 times daily for 3 months.
Outcomes
Primary Outcome Measures
Patient-reported Vulvar Quality of Life
Vulvar Quality of Life Index
Secondary Outcome Measures
Patient-reported symptoms
Likert scales to measure:
Pruritus/itchiness
Tender/sore
Swelling
Dryness
Burning of skin
Dyspareunia
Stinging with urination/clothes
Defecating pain/burning
Severity of overall condition
Clinician-rated severity of atrophic vaginitis
Product rating
Likert scale for product rating by the patient
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05432154
Brief Title
An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis
Official Title
Efficacy and Safety of a Novel Silicone Wound Dressing for the Management of Atrophic Vaginitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 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
Yes
Product Manufactured in and Exported from the U.S.
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 atrophic vaginitis in female patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Vaginitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
Patients apply 7-0940 at least 2 times daily for 3 months.
Intervention Type
Device
Intervention Name(s)
Film forming silicone gel (7-0940)
Intervention 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.
Primary Outcome Measure Information:
Title
Patient-reported Vulvar Quality of Life
Description
Vulvar Quality of Life Index
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patient-reported 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
3 months
Title
Severity of overall condition
Description
Clinician-rated severity of atrophic vaginitis
Time Frame
3 months
Title
Product rating
Description
Likert scale for product rating by the patient
Time Frame
3 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Orange Coast Women's Medical Group
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis
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