Fractional Photothermolysis for the Treatment of Burn Scars

Phase 1

• Conditions: Scar
• Interventions: Procedure: Fractional laser treatment; Procedure: Standard scar management

• Registration Number: NCT01005992
• Lead Sponsor: Clinica las Condes, Chile

Brief Summary

The aim of our study is to determine the effect of fractional photothermolysis laser in the treatment of burn scars.

Detailed Description

One of the main problems in the management of burned patients is the treatment of post-burn scarring. Frequently this scars cover large areas, tend to retract, present pigmentary changes and are disfiguring, producing significant life quality impairment.

Unfortunately, there are very few therapeutic options for treating these scars, which can be secondary to reconstructive surgery or after spontaneous healing. In the last decades most reports in scar treatment have included, pressure garments, chemical peeling, dermabrasion, ablative and non-ablative laser therapy and surgery with varying degrees of success. There is only one report treating burn scars with fractional laser, with good results.

The aim of our study is to determine the effect of of a second-generation erbium-doped 1,550-nm fractional photothermolysis laser (Fraxel SR laser, Reliant Technologies Inc.) in the treatment of burn scars.

Study Timeline

• Status Verified: 2009-10
• Study First Submitted: 2009-10-30
• Study First Submitted QC: 2009-10-30
• Last Update Submitted: 2009-10-30
• Study Start: 2009-11
• Study First Posted: 2009-11-01
• Last Update Posted: 2009-11-01
• Primary Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Burn scars should be located on the anterior thorax or abdomen with at least 4 months of evolution.
• The scar should be slightly elevated, with erythema and with no signs of keloid formation.
• Maximum scar dimension: 0.2 - 1% body surface area.
• Acceptance of informed consent for laser treatment.

Exclusion Criteria

• Previous non-surgical treatment (i.e. dermabrasion, laser, peelings, bleaching agent. etc).
• Previous surgical treatment (i.e. graft)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser treated scar	Fractional laser treatment	The standard treated scar arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities.
Standard scar management	Standard scar management	The standard scar management arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities.

Primary Outcome Measures

Name	Time	Method
Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography.	5 months
Adverse effects: pain, erythema, edema, hypopigmentation, hyperpigmentation, hypertrophic scar and keloid formation	5 months

Secondary Outcome Measures

Name	Time	Method
Change in surface area and perimeter of burn scar	5 months
Tissue pliability, elevation and flexibility with a digital piedemeter	5 months
Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope.	5 months

Trial Locations

Locations (1)

Clinica Las Condes; 🇨🇱 Santiago, RM, Chile