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Fractional Photothermolysis for the Treatment of Burn Scars

Primary Purpose

Scar

Status
Unknown status
Phase
Phase 1
Locations
Chile
Study Type
Interventional
Intervention
Fractional laser treatment
Standard scar management
Sponsored by
Clinica las Condes, Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scar focused on measuring Scars secondary to injuries to tissues caused by contact with physical (heat, electricity) o chemical agent.

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Clinica Las Condes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laser treated scar

Standard scar management

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography.
Adverse effects: pain, erythema, edema, hypopigmentation, hyperpigmentation, hypertrophic scar and keloid formation

Secondary Outcome Measures

Change in surface area and perimeter of burn scar
Tissue pliability, elevation and flexibility with a digital piedemeter
Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope.

Full Information

First Posted
October 30, 2009
Last Updated
October 30, 2009
Sponsor
Clinica las Condes, Chile
Collaborators
Corporacion de ayuda al niño quemado (COANIQUEM), Solta Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01005992
Brief Title
Fractional Photothermolysis for the Treatment of Burn Scars
Official Title
Fractional Photothermolysis for the Treatment of Burn Scars
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Clinica las Condes, Chile
Collaborators
Corporacion de ayuda al niño quemado (COANIQUEM), Solta Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar
Keywords
Scars secondary to injuries to tissues caused by contact with physical (heat, electricity) o chemical agent.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser treated scar
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard scar management
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fractional laser treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard scar management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography.
Time Frame
5 months
Title
Adverse effects: pain, erythema, edema, hypopigmentation, hyperpigmentation, hypertrophic scar and keloid formation
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Change in surface area and perimeter of burn scar
Time Frame
5 months
Title
Tissue pliability, elevation and flexibility with a digital piedemeter
Time Frame
5 months
Title
Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo Schwartz, MD
Phone
56-2-6108661
Email
schwartz.rodrigo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo J Schwartz, MD
Organizational Affiliation
Clinica Las Condes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Las Condes
City
Santiago
State/Province
RM
Country
Chile
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo J Schwartz, MD
Phone
56-2-6108661
First Name & Middle Initial & Last Name & Degree
Fresia Solias
Email
investigacion@coaniquem.cl
First Name & Middle Initial & Last Name & Degree
Rodrigo J Schwartz, MD
First Name & Middle Initial & Last Name & Degree
Fresia Solis
First Name & Middle Initial & Last Name & Degree
Gonzalo Eguiguren, MD
First Name & Middle Initial & Last Name & Degree
Jorge Rojas, MD
First Name & Middle Initial & Last Name & Degree
pedro lobos, MD
First Name & Middle Initial & Last Name & Degree
Patricia Apt, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19040687
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.
Results Reference
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PubMed Identifier
17338685
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.
Results Reference
background
PubMed Identifier
19309424
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.
Results Reference
background
PubMed Identifier
19291747
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.
Results Reference
background
PubMed Identifier
18246699
Citation
Waibel J, Beer K. Fractional laser resurfacing for thermal burns. J Drugs Dermatol. 2008 Jan;7(1):59-61.
Results Reference
background
PubMed Identifier
19271380
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.
Results Reference
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Learn more about this trial

Fractional Photothermolysis for the Treatment of Burn Scars

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