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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UNKNOWN
25 participants
OBSERVATIONAL
Brief Summary
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Detailed Description
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Different treatments are used such as intralesional injected steroids, topically used oily creams, silicone sheets or occlusive dressings. Compression garments are also frequently used. There is some evidence as to the effectivity of silicone sheets for recuction of hypertrophic scarring, however, these sheets cannot be used easily on all anatomical locations.
Valeant Pharmaceuticals International has developed a silicone based scar remodelling gel, Dermatix®, which has been empirically shown by others to have potential to reduce hypertrophic scars.
Primary objectives are to demonstrate effectivity of Dermatix in promoting maturation of the scar, versus a control region that will be treated with an indifferent cream.
Conditions
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Keywords
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Written informed consent
3. Scar size enabling the definition of two distinct scar areas, with similar scar characteristics at inclusion, preferably symmetric scars.
4. Patients of 18 years or older
Exclusion Criteria
2. Any patient condition that may influence the compliance of the treatment negatively.
18 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Association of Dutch Burn Centres
OTHER
Principal Investigators
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Esther Middelkoop, PhD
Role: STUDY_DIRECTOR
Association of Dutch Burn Centres
Locations
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Association of Dutch Burn Centres
Beverwijk, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Antoon van den Bogaerdt, PhD
Role: primary
Esther Middelkoop, PhD
Role: backup
Other Identifiers
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DERMO0501
Identifier Type: -
Identifier Source: org_study_id