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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01005992
Other study ID # CLCCQFQ-1
Secondary ID
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. completion date
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


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
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