Non Ablative Fractional Laser Treatment of Burn Scars

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02014298

Enrollment

Registered

2013-12-18

Start date

2012-01-31

Completion date

2012-10-31

Last updated

2013-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Scars

Keywords

Burns, Non-ablative fractional laser, scar texture, histology, laser treatment, erbium:glass laser, meshed skin-grafts, photothermolysis, skin

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).

Interventions

RADIATIONnon-ablative fractional laser

3 treatments with 4-6 weeks interval

OTHERcontrol

observation, comparison to laser-treated area

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026