An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis
NCT ID: NCT05432154
Last Updated: 2022-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2022-04-01
2022-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment arm
Patients apply 7-0940 at least 2 times daily for 3 months.
Film forming silicone gel (7-0940)
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.
Interventions
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Film forming silicone gel (7-0940)
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
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Inclusion Criteria
* Diagnosed acute or chronic Atrophic Vaginitis
* Controlled disease, or uncontrolled disease that did not respond to standard therapy with HRT
Exclusion Criteria
* 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
FEMALE
No
Sponsors
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Stratpharma AG
INDUSTRY
Responsible Party
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Locations
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Orange Coast Women's Medical Group
Laguna Hills, California, United States
Countries
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Other Identifiers
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SPAMG01
Identifier Type: -
Identifier Source: org_study_id
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