Non Ablative Fractional Laser Treatment of Burn Scars

NCT02014298 | Completed

• 1 other identifier: H3-2009-149
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Burn Scars

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in overall Scar-appearance

  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.

  1,3 and 6 months follow-up

Secondary Outcomes (1)

• specific clinical and histological scar appearance

  1, 3, and 6 months follow-up

Study Arms (2)

Control

OTHER

One area assessed as a control area, compared to the laser-treated area

Radiation: non-ablative fractional laser

Non-ablative Laser treatment

ACTIVE COMPARATOR

3 Non-ablative fractional laser treatments of one area

Other: control

Interventions

non-ablative fractional laser RADIATION

3 treatments with 4-6 weeks interval

Also known as: non-ablative fractional er:glass laser, 1,540 nm laser treatment

Control

control OTHER

observation, comparison to laser-treated area

Also known as: observation

Non-ablative Laser treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital, University of Copenhagen

Copenhagen NV, Copenhagen, DK-2400, Denmark

Location

MeSH Terms

Conditions

Burns

Interventions

Observation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Merete Hædersdal, MD,PhD,DmSc

  Bispebjerg Hospital, University of Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 18, 2013
• Study Start: January 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 18, 2013

Record last verified: 2013-12

Locations

DK (1)