Fractional Photothermolysis for the Treatment of Burn Scars

Clinica las Condes, Chile

Status and phase: Unknown; Phase 1

Conditions: Scar

Treatments: Procedure: Standard scar management; Procedure: Fractional laser treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01005992

CLCCQFQ-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Laser treated scar

Experimental group

Description:

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.

Treatment:

Procedure: Fractional laser treatment

Standard scar management

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard scar management