Effectivity of Dermatix in Promoting Scar Maturation

Sponsor

Association of Dutch Burn Centres (Other)

Overall Status

Unknown status

CT.gov ID

NCT00548210

Collaborator

Bausch Health Americas, Inc. (Industry)

Enrollment

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypertrophic Scars

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

25 participants

Time Perspective:

Prospective

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with hypertrophic scarring and/or ropes, stable for at least 3 months before inclusion.
Written informed consent
Scar size enabling the definition of two distinct scar areas, with similar scar characteristics at inclusion, preferably symmetric scars.
Patients of 18 years or older

Exclusion criteria:

Known sensitivity for occlusive dressings or silicone containing products
Any patient condition that may influence the compliance of the treatment negatively.