Fractional Photothermolysis for the Treatment of Burn Scars
NCT ID: NCT01005992
Last Updated: 2009-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
10 participants
INTERVENTIONAL
2009-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 surgical treatment (i.e. graft)
6 Years
16 Years
ALL
No
Sponsors
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Corporacion de ayuda al niño quemado (COANIQUEM)
UNKNOWN
Solta Medical
INDUSTRY
Clinica las Condes, Chile
OTHER
Responsible Party
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Clinica Las Condes
Principal Investigators
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Rodrigo J Schwartz, MD
Role: PRINCIPAL_INVESTIGATOR
Clinica Las Condes
Locations
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Clinica Las Condes
Santiago, RM, Chile
Countries
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Central Contacts
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Facility Contacts
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Rodrigo J Schwartz, MD
Role: primary
References
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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.
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. doi: 10.1111/j.1524-4725.2007.33058.x.
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. No abstract available.
Haedersdal M, Moreau KE, Beyer DM, Nymann P, Alsbjorn 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.
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.
Other Identifiers
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CLCCQFQ-1
Identifier Type: -
Identifier Source: org_study_id
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