Effectivity of Dermatix in Promoting Scar Maturation

Hypertrophic Scars Clinical Trial

Official title:

Dermatix; A Randomized Controlled Trial Measuring Effectivity of Dermatix in Promoting Scar Maturation of Hypertrophic Scars.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00548210
• Other study ID #: DERMO0501
• 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
• 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

• Cicatrix, Hypertrophic
• Hypertrophic Scars
• Hypertrophy

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,