Burn Scars Clinical Trial
Official title:
LONG-TERM AND CONTINUED IMPROVEMENT OF MATURE BURN SCARS IN RESPONSE TO NONABLATIVE FRACTIONAL LASER - A RANDOMIZED CONTROLLED TRIAL WITH HISTOLOGICAL EVALUATION
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).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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