Non Ablative Fractional Laser Treatment of Burn Scars

Study Overview
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Brief Summary
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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).

Official Title
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LONG-TERM AND CONTINUED IMPROVEMENT OF MATURE BURN SCARS IN RESPONSE TO NONABLATIVE FRACTIONAL LASER - A RANDOMIZED CONTROLLED TRIAL WITH HISTOLOGICAL EVALUATION

Conditions
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Burn Scars

Intervention / Treatment
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* Radiation: non-ablative fractional laser
* Other: control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>One area assessed as a control area, compared to the laser-treated area | Radiation: non-ablative fractional laser<br>* 3 treatments with 4-6 weeks interval<br>* Other names: 1,540 nm laser treatment;|
| Active Comparator: Non-ablative Laser treatment<br>3 Non-ablative fractional laser treatments of one area | Other: control<br>* observation, comparison to laser-treated area<br>* Other names: observation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1,3 and 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 1, 3, and 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burns, Non-ablative fractional laser, scar texture, histology, laser treatment, erbium:glass laser, meshed skin-grafts, photothermolysis, skin