Back to resultsFractional Nonablative 1540 nm Laser Resurfacing for Burn Scars- A Randomised Controlled Trial
Primary Purpose
Burn Scar Patients
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
1540 nm fractional laser
Sponsored by
About this trial
This is an interventional trial for Burn Scar Patients
Eligibility Criteria
Inclusion Criteria:
- Burn scars with and without previous skin grafting.
Exclusion Criteria:
- A tendency to produce hypertrophic scars or keloids,
- Previous treatment with dermabrasio, chemical peel, filler, laser treatment or Intense Pulsed Light (IPL) of study areas,
- Photosensitivity,
- Pregnancy or lactation,
- Current anticoagulative medication,
- Oral retinoid drugs within the past 6 months,
- Pigmentation after recent exposure to sun or solarium,
- Patients not considered to be able to follow the treatment protocol.
Sites / Locations
- Bispebjerg University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Change of skin texture from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00689650
Brief Title
Fractional Nonablative 1540 nm Laser Resurfacing for Burn Scars- A Randomised Controlled Trial
Official Title
Fractional Nonablative 1540 nm Laser Resurfacing for Burn Scars- A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
5. Study Description
Brief Summary
The objective was to evaluate the efficacy of 1540 nm fractional laser treatment of mature burn scars.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Scar Patients
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
1540 nm fractional laser
Primary Outcome Measure Information:
Title
Change of skin texture from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Burn scars with and without previous skin grafting.
Exclusion Criteria:
A tendency to produce hypertrophic scars or keloids,
Previous treatment with dermabrasio, chemical peel, filler, laser treatment or Intense Pulsed Light (IPL) of study areas,
Photosensitivity,
Pregnancy or lactation,
Current anticoagulative medication,
Oral retinoid drugs within the past 6 months,
Pigmentation after recent exposure to sun or solarium,
Patients not considered to be able to follow the treatment protocol.
Facility Information:
Facility Name
Bispebjerg University Hospital
City
Copenhagen NV
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Fractional Nonablative 1540 nm Laser Resurfacing for Burn Scars- A Randomised Controlled Trial
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