Non Ablative Fractional Laser Treatment of Burn Scars

Bispebjerg Hospital

Status: Completed

Conditions: Burn Scars

Treatments: Radiation: non-ablative fractional laser; Other: control

Study type: Interventional

Funder types: Other

Identifiers

NCT02014298

H3-2009-149

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Control

Other group

Description:

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

Treatment:

Radiation: non-ablative fractional laser

Non-ablative Laser treatment

Active Comparator group

Description:

3 Non-ablative fractional laser treatments of one area

Treatment:

Other: control