Effectivity of Dermatix in Promoting Scar Maturation
|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.|
|ClinicalTrials.gov Identifier: NCT00548210|
Recruitment Status : Unknown
Verified October 2007 by Association of Dutch Burn Centres.
Recruitment status was: Recruiting
First Posted : October 23, 2007
Last Update Posted : October 23, 2007
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Dermatix; A Randomized Controlled Trial Measuring Effectivity of Dermatix in Promoting Scar Maturation of Hypertrophic Scars.|
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
|Contact: Antoon van den Bogaerdt, PhD||+31 251 264917||AvdBogaerdt@rkz.nl|
|Contact: Esther Middelkoop, PhD||+31 251 265283||EMiddelkoop@rkz.nl|
|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|
|Study Director:||Esther Middelkoop, PhD||Association of Dutch Burn Centres|