Clinical trial NCT01005992: Fractional Photothermolysis for the Treatment of Burn Scars
Official title: Fractional Photothermolysis for the Treatment of Burn Scars
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Scar
Keywords: Scars secondary to injuries to tissues caused by contact with physical (heat, electricity) o chemical agent.
Lead sponsor: Clinica las Condes, Chile
Sponsor class: OTHER
Collaborators: name: Corporacion de ayuda al niño quemado (COANIQUEM)
name: Solta Medical
First posted: 2009-11-01
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography.
timeFrame: 5 months
measure: Adverse effects: pain, erythema, edema, hypopigmentation, hyperpigmentation, hypertrophic scar and keloid formation
timeFrame: 5 months
Secondary outcomes:
measure: Change in surface area and perimeter of burn scar
timeFrame: 5 months
measure: Tissue pliability, elevation and flexibility with a digital piedemeter
timeFrame: 5 months
measure: Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope.
timeFrame: 5 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clinica Las Condes
state: RM
Study officials:
affiliation: Clinica Las Condes
name: Rodrigo J Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1111/j.1524-4725.2007.33058.x.
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. No abstract available.
citation: 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.
citation: Waibel J, Beer K. Fractional laser resurfacing for thermal burns. J Drugs Dermatol. 2008 Jan;7(1):59-61.
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.