Fractional Photothermolysis for the Treatment of Burn Scars - Full Text View

Purpose

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

Condition	Intervention	Phase
Scar	Procedure: Fractional laser treatment Procedure: Standard scar management	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Fractional Photothermolysis for the Treatment of Burn Scars

Resource links provided by NLM:

MedlinePlus related topics: Burns Scars

U.S. FDA Resources

Further study details as provided by Clinica las Condes, Chile:

Primary Outcome Measures:

Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Adverse effects: pain, erythema, edema, hypopigmentation, hyperpigmentation, hypertrophic scar and keloid formation [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in surface area and perimeter of burn scar [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Tissue pliability, elevation and flexibility with a digital piedemeter [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope. [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	November 2009
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Laser treated scar 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.	Procedure: Fractional laser treatment 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.
Active Comparator: 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.	Procedure: Standard 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.

Arms

Assigned Interventions

Experimental: Laser treated scar

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.

Procedure: Fractional laser treatment

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.

Active Comparator: 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.

Procedure: Standard 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.

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.

Eligibility

Ages Eligible for Study:	6 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005992

Contacts

Contact: Rodrigo Schwartz, MD

56-2-6108661

schwartz.rodrigo@gmail.com

Locations

Chile
Clinica Las Condes	Not yet recruiting
Santiago, RM, Chile
Contact: Rodrigo J Schwartz, MD 56-2-6108661
Contact: Fresia Solias investigacion@coaniquem.cl
Principal Investigator: Rodrigo J Schwartz, MD
Sub-Investigator: Fresia Solis
Sub-Investigator: Gonzalo Eguiguren, MD
Sub-Investigator: Jorge Rojas, MD
Sub-Investigator: pedro lobos, MD
Sub-Investigator: Patricia Apt, MD

Sponsors and Collaborators

Clinica las Condes, Chile

Corporacion de ayuda al niño quemado (COANIQUEM)

Solta Medical

Investigators

Principal Investigator:

Rodrigo J Schwartz, MD

Clinica Las Condes

More Information

Publications:

Chrastil B, Glaich AS, Goldberg LH, Friedman PM. Second-generation 1,550-nm fractional photothermolysis for the treatment of acne scars. Dermatol Surg. 2008 Oct;34(10):1327-32.

Glaich AS, Rahman Z, Goldberg LH, Friedman PM. Fractional resurfacing for the treatment of hypopigmented scars: a pilot study. Dermatol Surg. 2007 Mar;33(3):289-94; discussion 293-4.

Haedersdal M. Fractional ablative CO(2) laser resurfacing improves a thermal burn scar. J Eur Acad Dermatol Venereol. 2009 Nov;23(11):1340-1. Epub 2009 Mar 4. No abstract available.

Haedersdal M, Moreau KE, Beyer DM, Nymann P, Alsbjørn B. Fractional nonablative 1540 nm laser resurfacing for thermal burn scars: a randomized controlled trial. Lasers Surg Med. 2009 Mar;41(3):189-95.

Waibel J, Beer K. Fractional laser resurfacing for thermal burns. J Drugs Dermatol. 2008 Jan;7(1):59-61.

Waibel J, Beer K. Ablative fractional laser resurfacing for the treatment of a third-degree burn. J Drugs Dermatol. 2009 Mar;8(3):294-7.

Responsible Party:	Rodrigo Schwartz M.D., Clinica Las Condes
ClinicalTrials.gov Identifier:	NCT01005992 History of Changes
Other Study ID Numbers:	CLCCQFQ-1
Study First Received:	October 30, 2009
Last Updated:	October 30, 2009
Health Authority:	Chile: Instituto de Salud Publica de Chile

Keywords provided by Clinica las Condes, Chile:

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

Additional relevant MeSH terms:

Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013