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Effectivity of Dermatix in Promoting Scar Maturation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Association of Dutch Burn Centres.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00548210
First Posted: October 23, 2007
Last Update Posted: October 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by:
Association of Dutch Burn Centres
  Purpose
The purpose of this research is to demonstrate effectivity of Dermatix in promoting maturation of the scar, versus a control region that will be treated with an indifferent cream.

Condition Phase
Hypertrophic Scars Phase 3

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Dermatix; A Randomized Controlled Trial Measuring Effectivity of Dermatix in Promoting Scar Maturation of Hypertrophic Scars.

Resource links provided by NLM:


Further study details as provided by Association of Dutch Burn Centres:

Estimated Enrollment: 25
Detailed Description:

The healing of deep thermal injuries is always associated with scarring. The healing process can lead to the formation of large scar bundles (e.g. hypertrophic scars). The scars can be discomforting, disfiguring and restrict motion if situated over or near joints. Evidence for effectivity of treatment for reduction of hypertrophic scars or the prevention of them is limited.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with hypertrophic scarring and/or ropes, stable for at least 3 months before inclusion.
  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:

  1. Known sensitivity for occlusive dressings or silicone containing products
  2. Any patient condition that may influence the compliance of the treatment negatively.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548210


Contacts
Contact: Antoon van den Bogaerdt, PhD +31 251 264917 AvdBogaerdt@rkz.nl
Contact: Esther Middelkoop, PhD +31 251 265283 EMiddelkoop@rkz.nl

Locations
Netherlands
Association of Dutch Burn Centres Recruiting
Beverwijk, Noord-Holland, Netherlands, 1940 EB
Contact: Antoon van den Bogaerdt, PhD    +31 251 264917    AvdBogaerdt@rkz.nl   
Contact: Esther Middelkoop, PhD    +31 251 264917    EMiddelkoop@rkz.nl   
Principal Investigator: Antoon van den Bogaerdt, PhD         
Sponsors and Collaborators
Association of Dutch Burn Centres
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Esther Middelkoop, PhD Association of Dutch Burn Centres
  More Information

ClinicalTrials.gov Identifier: NCT00548210     History of Changes
Other Study ID Numbers: DERMO0501
First Submitted: October 22, 2007
First Posted: October 23, 2007
Last Update Posted: October 23, 2007
Last Verified: October 2007

Keywords provided by Association of Dutch Burn Centres:
Hypertrophy
scarring
scar treatment
silicone

Additional relevant MeSH terms:
Hypertrophy
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Cicatrix
Fibrosis
Pathologic Processes