a Flexible Wound Dressing for the Management of Genital Skin Conditions
NCT ID: NCT05396261
Last Updated: 2022-05-31
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
54 participants
INTERVENTIONAL
2018-01-31
2022-02-01
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
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.
Film forming silicone gel (7-0940)
Anecdotal evidence suggests that genital conditions in women associated with vaginal atrophy improve with the use of film-forming silicone dressings.
Interventions
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Film forming silicone gel (7-0940)
Anecdotal evidence suggests that genital conditions in women associated with vaginal atrophy improve with the use of film-forming silicone dressings.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed genital skin condition
Exclusion Criteria
* Patient unable to apply topical device
* Allergy or intolerance to ingredients or excipients of the formulation of studied products
FEMALE
No
Sponsors
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Stratpharma AG
INDUSTRY
Responsible Party
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Principal Investigators
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Philip Hall, MD
Role: PRINCIPAL_INVESTIGATOR
St. Andrews War Memorial Hospital - Australia
Locations
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St. Andrews War Memorial Hospital
Spring Hill, Queensland, Australia
Countries
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References
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Hall P. A Feasibility Study Investigating a Topical Preparation as Novel Adjunct Treatment for the Symptomatic Management of Vulvovaginal Skin Conditions. Womens Health Rep (New Rochelle). 2024 May 17;5(1):444-452. doi: 10.1089/whr.2024.0026. eCollection 2024.
Other Identifiers
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SPASMSX01 HALL
Identifier Type: -
Identifier Source: org_study_id