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Fractional Photothermolysis for the Treatment of Burn Scars

Fractional Photothermolysis for the Treatment of Burn Scars

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01005992
Enrollment
10
Registered
2009-11-02
Start date
2009-11-30
Completion date
Unknown
Last updated
2009-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scar

Keywords

Scars secondary to injuries to tissues caused by contact with physical (heat, electricity) o chemical agent.

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.

Interventions

A complete treatment will consist in four laser sessions with a second-generation erbium-doped 1,550-nm fractional photothermolysis laser (Fraxel SR laser, Reliant Technologies Inc at 1-month intervals. Treatment will be delivered with a 15-mm tip and concomitant air-cooling system (Zimmer MedizinSystems, Irvine, CA). Fluence and treatment level will be registered on every session and will be adjusted according to patient tolerance.

PROCEDUREStandard scar management

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.

Sponsors

Clinica las Condes, Chile
Lead SponsorOTHER
Corporacion de ayuda al niño quemado (COANIQUEM)
CollaboratorUNKNOWN
Solta Medical
CollaboratorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
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 formation5 months

Secondary

MeasureTime frame
Change in surface area and perimeter of burn scar5 months
Tissue pliability, elevation and flexibility with a digital piedemeter5 months
Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope.5 months

Countries

Chile

Contacts

Primary ContactRodrigo Schwartz, MD
schwartz.rodrigo@gmail.com56-2-6108661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026