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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00548210
Study type Observational
Source Association of Dutch Burn Centres
Contact Antoon van den Bogaerdt, PhD
Phone +31 251 264917
Email AvdBogaerdt@rkz.nl
Status Recruiting
Phase Phase 3

See also
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Withdrawn NCT02546076 - Comparison of Dual-mode ER:YAG Laser in Patients With Long Keloid/Hypertrophic Scars Phase 2
Withdrawn NCT01858038 - Gene Expression During Surgical Scar Remodeling by Fractional Photothermolysis N/A
Active, not recruiting NCT04389619 - Fractional Microneedling RF vs Intralesional Steroid With & Without Microneedling in Hypertrophic Scars N/A
Active, not recruiting NCT01113125 - Scars After Central Venous Catheters Phase 3
Active, not recruiting NCT00849004 - Prevention of Hypertrophic Scars or Keloids N/A
Completed NCT00142441 - Effect of Pulse Width on Scar Treatment Using a 595-nm Pulsed Dye Laser N/A
Completed NCT01078428 - Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars Phase 4
Withdrawn NCT02655211 - Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial N/A
Completed NCT02487212 - Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery Phase 4
Active, not recruiting NCT04532840 - Effect of Cryotherpy on Hypertrophic Scar Phase 2/Phase 3