LONG-TERM AND CONTINUED IMPROVEMENT OF MATURE BURN SCARS IN RESPONSE TO NONABLATIVE FRACTIONAL LASER - A RANDOMIZED CONTROLLED TRIAL WITH HISTOLOGICAL EVALUATION
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change in overall Scar-appearance
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Outcomes
Primary Outcomes
Change in overall Scar-appearance
Time Frame: 1,3 and 6 months follow-up
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 Outcomes
- specific clinical and histological scar appearance(1, 3, and 6 months follow-up)
Investigators
Elisabeth Taudorf
MD
Bispebjerg Hospital