Fractional Photothermolysis for the Treatment of Burn Scars

Scar Clinical Trial

Official title:

Fractional Photothermolysis for the Treatment of Burn Scars

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01005992
• Other study ID #: CLCCQFQ-1
• Status: Not yet recruiting
• Phase: Phase 1
• First received: October 30, 2009
• Last updated: October 30, 2009
• Start date: November 2009

Study information

• Verified date: October 2009
• Source: Clinica las Condes, Chile
• Contact: Rodrigo Schwartz, MD
• Phone: 56-2-6108661
• Email: schwartz.rodrigo[@]gmail.com
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scar

Intervention

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.
• 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.

Locations

Country	Name	City	State
Chile	Clinica Las Condes	Santiago	RM

Sponsors (3)

Lead Sponsor	Collaborator
Clinica las Condes, Chile	Corporacion de ayuda al niño quemado (COANIQUEM), Solta Medical

Country where clinical trial is conducted

Chile, 

References & Publications (6)

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. doi: 10.1111/j.1524-4725.2008.34284.x. — View Citation

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. — View Citation

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. doi: 10.1002/lsm.20756. — View Citation

Haedersdal M. Fractional ablative CO(2) laser resurfacing improves a thermal burn scar. J Eur Acad Dermatol Venereol. 2009 Nov;23(11):1340-1. doi: 10.1111/j.1468-3083.2009.03215.x. Epub 2009 Mar 4. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography.		5 months	No
Primary	Adverse effects: pain, erythema, edema, hypopigmentation, hyperpigmentation, hypertrophic scar and keloid formation		5 months	Yes
Secondary	Change in surface area and perimeter of burn scar		5 months	No
Secondary	Tissue pliability, elevation and flexibility with a digital piedemeter		5 months	No
Secondary	Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope.		5 months	No