- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01005992
Fractional Photothermolysis for the Treatment of Burn Scars
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Rodrigo Schwartz, MD
- Phone Number: 56-2-6108661
- Email: schwartz.rodrigo@gmail.com
Study Locations
-
-
RM
-
Santiago, RM, Chile
- Clinica Las Condes
-
Contact:
- Rodrigo J Schwartz, MD
- Phone Number: 56-2-6108661
-
Contact:
- Fresia Solias
- Email: investigacion@coaniquem.cl
-
Principal Investigator:
- Rodrigo J Schwartz, MD
-
Sub-Investigator:
- Fresia Solis
-
Sub-Investigator:
- Gonzalo Eguiguren, MD
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Sub-Investigator:
- Jorge Rojas, MD
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Sub-Investigator:
- pedro lobos, MD
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Sub-Investigator:
- Patricia Apt, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography.
Time Frame: 5 months
|
5 months
|
Adverse effects: pain, erythema, edema, hypopigmentation, hyperpigmentation, hypertrophic scar and keloid formation
Time Frame: 5 months
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in surface area and perimeter of burn scar
Time Frame: 5 months
|
5 months
|
Tissue pliability, elevation and flexibility with a digital piedemeter
Time Frame: 5 months
|
5 months
|
Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope.
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rodrigo J Schwartz, MD, Clinica Las Condes
Publications and helpful links
General 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. 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLCCQFQ-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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