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Completed

NCT Number: NCT02014298

Non Ablative Fractional Laser Treatment of Burn Scars

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).

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Key information

Conditions

Burn Scars Burns Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital, University of Copenhagen

Copenhagen NV, Copenhagen, DK-2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

non-ablative fractional laser

Radiation

3 treatments with 4-6 weeks interval

Other names: non-ablative fractional er:glass laser, 1,540 nm laser treatment

Control

Other

observation, comparison to laser-treated area

Other names: observation

Primary outcomes

  1. 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

  1. specific clinical and histological scar appearance

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 18, 2013
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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