Non Ablative Fractional Laser Treatment of Burn Scars

Not Applicable

Completed

• Conditions: Burn Scars
• Interventions: Radiation: non-ablative fractional laser; Other: control

• Registration Number: NCT02014298
• Lead Sponsor: Bispebjerg Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-12
• Study First Submitted: 2013-12-12
• Study First Submitted QC: 2013-12-12
• Last Update Submitted: 2013-12-12
• Study First Posted: 2013-12-18
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	non-ablative fractional laser	One area assessed as a control area, compared to the laser-treated area
Non-ablative Laser treatment	control	3 Non-ablative fractional laser treatments of one area

Primary Outcome Measures

Name	Time	Method
Change in overall Scar-appearance	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 Outcome Measures

Name	Time	Method
specific clinical and histological scar appearance	1, 3, and 6 months follow-up	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)

Trial Locations

Locations (1)

Bispebjerg Hospital, University of Copenhagen; 🇩🇰 Copenhagen NV, Copenhagen, Denmark