CClinicalTrials.gg
Status unknownNCT00548210Updated Oct 23, 2007

Effectivity of Dermatix in Promoting Scar Maturation

An observational study in Hypertrophic Scars, sponsored by Association of Dutch Burn Centres. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-10-23.

Sponsored by Association of Dutch Burn Centres · Observational

The sponsor has not verified this record recently (last verified Oct 2007), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertrophic Scars

Keywords

  • Hypertrophy
  • scarring
  • scar treatment
  • silicone
03

In context

Hypertrophy

656 studies on the registry are indexed under Hypertrophy; 87 are open to participants now.

This study's planned enrollment of 25 is below the median of 120 across 169 observational studies indexed under Hypertrophy.

Browse Hypertrophy studies →

Lead sponsor

Association of Dutch Burn Centres is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Time perspective
Prospective
Enrollment
25 participants (estimated)
06

Study locations

1 of 1 sites recruiting
  • Association of Dutch Burn Centres
    Beverwijk, Noord-Holland 1940 EB, Netherlands
    • Antoon van den Bogaerdt, PhD · Contact · AvdBogaerdt@rkz.nl · +31 251 264917
    • Esther Middelkoop, PhD · Contact · EMiddelkoop@rkz.nl · +31 251 264917
    • Antoon van den Bogaerdt, PhD · Principal investigator
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00548210
Lead sponsor
Association of Dutch Burn Centres
Collaborators
Bausch Health Americas, Inc.
First posted
Oct 23, 2007
Last update
Oct 23, 2007

Study contacts

Antoon van den Bogaerdt, PhD
Contact
AvdBogaerdt@rkz.nl
+31 251 264917
Esther Middelkoop, PhD
Contact
EMiddelkoop@rkz.nl
+31 251 265283
Esther Middelkoop, PhD
study director · Association of Dutch Burn Centres
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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