Effectivity of Dermatix in Promoting Scar Maturation

October 22, 2007 updated by: Association of Dutch Burn Centres

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Antoon van den Bogaerdt, PhD
  • Phone Number: +31 251 264917
  • Email: AvdBogaerdt@rkz.nl

Study Contact Backup

Study Locations

  • Netherlands
    • Noord-Holland
      • Beverwijk, Noord-Holland, Netherlands, 1940 EB
        • Recruiting
        • Association of Dutch Burn Centres
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antoon van den Bogaerdt, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association of Dutch Burn Centres

Collaborators

Bausch Health Americas, Inc.

Investigators

  • Study Director: Esther Middelkoop, PhD, Association of Dutch Burn Centres

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 22, 2007

First Submitted That Met QC Criteria

October 22, 2007

First Posted (ESTIMATE)

October 23, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 23, 2007

Last Update Submitted That Met QC Criteria

October 22, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DERMO0501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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