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Non Ablative Fractional Laser Treatment of Burn Scars

NCT02014298 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-12-18

No results posted yet for this study

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).

Conditions

  • Burn Scars

Interventions

RADIATION

non-ablative fractional laser

3 treatments with 4-6 weeks interval

OTHER

control

observation, comparison to laser-treated area

Sponsors & Collaborators

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Merete Hædersdal, MD,PhD,DmSc · Bispebjerg Hospital, University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Denmark

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02014298 on ClinicalTrials.gov