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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00548210
Other study ID # DERMO0501
Secondary ID
Status Recruiting
Phase Phase 3
First received October 22, 2007
Last updated October 22, 2007

Study information

Verified date October 2007
Source Association of Dutch Burn Centres
Contact Antoon van den Bogaerdt, PhD
Phone +31 251 264917
Email AvdBogaerdt@rkz.nl
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Association of Dutch Burn Centres Beverwijk Noord-Holland

Sponsors (2)

Lead Sponsor Collaborator
Association of Dutch Burn Centres Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

Netherlands, 

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