Non Ablative Fractional Laser Treatment of Burn Scars

Burn Scars Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02014298
• Other study ID #: H3-2009-149
• Status: Completed
• Phase: N/A
• First received: December 12, 2013
• Last updated: December 12, 2013
• Start date: January 2012
• Est. completion date: October 2012

Study information

• Verified date: December 2013
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn Scars
• Burns

Intervention

Radiation:
• non-ablative fractional laser
3 treatments with 4-6 weeks interval

Other:
• control
observation, comparison to laser-treated area

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital, University of Copenhagen	Copenhagen NV	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	specific clinical and histological scar appearance	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)	1, 3, and 6 months follow-up	Yes