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Fractional Photothermolysis for the Treatment of Burn Scars

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ClinicalTrials.gov Identifier: NCT01005992
Recruitment Status : Unknown
Verified October 2009 by Clinica las Condes, Chile.
Recruitment status was:  Not yet recruiting
First Posted : November 2, 2009
Last Update Posted : November 2, 2009
Sponsor:
Collaborators:
Corporacion de ayuda al niño quemado (COANIQUEM)
Solta Medical
Information provided by:
Clinica las Condes, Chile

Tracking Information
First Submitted Date  ICMJE October 30, 2009
First Posted Date  ICMJE November 2, 2009
Last Update Posted Date November 2, 2009
Study Start Date  ICMJE November 2009
Estimated Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2009)
  • Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography. [ Time Frame: 5 months ]
  • Adverse effects: pain, erythema, edema, hypopigmentation, hyperpigmentation, hypertrophic scar and keloid formation [ Time Frame: 5 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2009)
  • Change in surface area and perimeter of burn scar [ Time Frame: 5 months ]
  • Tissue pliability, elevation and flexibility with a digital piedemeter [ Time Frame: 5 months ]
  • Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope. [ Time Frame: 5 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fractional Photothermolysis for the Treatment of Burn Scars
Official Title  ICMJE Fractional Photothermolysis for the Treatment of Burn Scars
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Scar
Intervention  ICMJE
  • 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.
  • Procedure: 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Fractional laser treatment
  • 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.
    Intervention: Procedure: Standard scar management
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 30, 2009)
10
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01005992
Other Study ID Numbers  ICMJE CLCCQFQ-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rodrigo Schwartz M.D., Clinica Las Condes
Study Sponsor  ICMJE Clinica las Condes, Chile
Collaborators  ICMJE
  • Corporacion de ayuda al niño quemado (COANIQUEM)
  • Solta Medical
Investigators  ICMJE
Principal Investigator: Rodrigo J Schwartz, MD Clinica Las Condes
PRS Account Clinica las Condes, Chile
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP