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Non Ablative Fractional Laser Treatment of Burn Scars

Primary Purpose

Burn Scars

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
non-ablative fractional laser
control
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Scars focused on measuring Burns, Non-ablative fractional laser, scar texture, histology, laser treatment, erbium:glass laser, meshed skin-grafts, photothermolysis, skin

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • legally competent adults aged 18-60 years
  • Fitzpatrick skin type I-III
  • burn scar 1 year or older
  • total scar area allowing selection of two similar side-by-side test areas of minimum 1.5 × 3 cm for study purpose

Exclusion Criteria:

  • pregnancy or lactation
  • suntan
  • wounds or infections in study area
  • tendency to form hypertrophic scars or keloids
  • oral retinoids, anti-inflammatory or immunosuppressive drugs within the last six months
  • current anticoagulants
  • previous treatments in test area with laser, Intense Pulsed Light, dermabrasion, chemical peel or filler.

Sites / Locations

  • Bispebjerg Hospital, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Control

Non-ablative Laser treatment

Arm Description

One area assessed as a control area, compared to the laser-treated area

3 Non-ablative fractional laser treatments of one area

Outcomes

Primary Outcome Measures

Change in overall Scar-appearance
Primary endpoint is change in overall scar-appearance assessed by a slightly modified Patient and Observer Scar Assessment Scale (evaluation of study area omitted since this is fixed as part of study procedure). Scale: 1= normal skin; 10= worst imaginable scar.

Secondary Outcome Measures

specific clinical and histological scar appearance
Additional assessments include: evaluation of vascularity, pigmentation, thickness, relief, pliability (evaluated on modified Patient and Observer Scar Assessment Scale) histological changes (Small safety issue from taking a 4 mm cutaneous punch biopsy) patient satisfaction adverse events (pain during treatment, immediate treatment reaction, 24h treatment reaction, evaluation of side effects at 6 months follow-up)

Full Information

First Posted
December 12, 2013
Last Updated
December 12, 2013
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02014298
Brief Title
Non Ablative Fractional Laser Treatment of Burn Scars
Official Title
LONG-TERM AND CONTINUED IMPROVEMENT OF MATURE BURN SCARS IN RESPONSE TO NONABLATIVE FRACTIONAL LASER - A RANDOMIZED CONTROLLED TRIAL WITH HISTOLOGICAL EVALUATION
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
BACKGROUND: Increasing evidence appears for non-ablative fractional laser (NAFL) to remodel mature burn scars. OBJECTIVES: To investigate long-term clinical and histological appearance of mature burn scars after NAFL-treatment. HYPOTHESIS: That NAFL can modulate mature burn scars with subsequently improved cosmetic and functional appearance. METHODS: Study patients with burn scars at trunk or extremities. Side-by-side test areas are randomized to three monthly 1,540 nm NAFL-treatments or control, followed by blinded evaluations at 1, 3, and 6 months using mPOSAS (modified Patient and Observer Scar Assessment Scale; 1 = normal skin, 10 = worst imaginable scar).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Scars
Keywords
Burns, Non-ablative fractional laser, scar texture, histology, laser treatment, erbium:glass laser, meshed skin-grafts, photothermolysis, skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
One area assessed as a control area, compared to the laser-treated area
Arm Title
Non-ablative Laser treatment
Arm Type
Active Comparator
Arm Description
3 Non-ablative fractional laser treatments of one area
Intervention Type
Radiation
Intervention Name(s)
non-ablative fractional laser
Other Intervention Name(s)
non-ablative fractional er:glass laser, 1,540 nm laser treatment
Intervention Description
3 treatments with 4-6 weeks interval
Intervention Type
Other
Intervention Name(s)
control
Other Intervention Name(s)
observation
Intervention Description
observation, comparison to laser-treated area
Primary Outcome Measure Information:
Title
Change in overall Scar-appearance
Description
Primary endpoint is change in overall scar-appearance assessed by a slightly modified Patient and Observer Scar Assessment Scale (evaluation of study area omitted since this is fixed as part of study procedure). Scale: 1= normal skin; 10= worst imaginable scar.
Time Frame
1,3 and 6 months follow-up
Secondary Outcome Measure Information:
Title
specific clinical and histological scar appearance
Description
Additional assessments include: evaluation of vascularity, pigmentation, thickness, relief, pliability (evaluated on modified Patient and Observer Scar Assessment Scale) histological changes (Small safety issue from taking a 4 mm cutaneous punch biopsy) patient satisfaction adverse events (pain during treatment, immediate treatment reaction, 24h treatment reaction, evaluation of side effects at 6 months follow-up)
Time Frame
1, 3, and 6 months follow-up

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: legally competent adults aged 18-60 years Fitzpatrick skin type I-III burn scar 1 year or older total scar area allowing selection of two similar side-by-side test areas of minimum 1.5 × 3 cm for study purpose Exclusion Criteria: pregnancy or lactation suntan wounds or infections in study area tendency to form hypertrophic scars or keloids oral retinoids, anti-inflammatory or immunosuppressive drugs within the last six months current anticoagulants previous treatments in test area with laser, Intense Pulsed Light, dermabrasion, chemical peel or filler.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete Hædersdal, MD,PhD,DmSc
Organizational Affiliation
Bispebjerg Hospital, University of Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
Bispebjerg Hospital, University of Copenhagen
City
Copenhagen NV
State/Province
Copenhagen
ZIP/Postal Code
DK-2400
Country
Denmark

12. IPD Sharing Statement

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Non Ablative Fractional Laser Treatment of Burn Scars

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