An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis
Efficacy and Safety of a Novel Silicone Wound Dressing for the Management of Atrophic Vaginitis
1 other identifier
interventional
10
1 country
1
Brief Summary
The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedAugust 24, 2022
August 1, 2022
4 months
June 20, 2022
August 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Patient-reported Vulvar Quality of Life
Vulvar Quality of Life Index
3 months
Secondary Outcomes (3)
Patient-reported symptoms
3 months
Severity of overall condition
3 months
Product rating
3 months
Study Arms (1)
Treatment arm
EXPERIMENTALPatients apply 7-0940 at least 2 times daily for 3 months.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stratpharma AGlead
Study Sites (1)
Orange Coast Women's Medical Group
Laguna Hills, California, 92653, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2022
First Posted
June 27, 2022
Study Start
April 1, 2022
Primary Completion
July 31, 2022
Study Completion
July 31, 2022
Last Updated
August 24, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share