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Burn Scar Appearance After Treatment With Fractional Carbon Dioxide (CO2) Laser

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00969215
Recruitment Status : Completed
First Posted : September 1, 2009
Last Update Posted : July 26, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine if fractional carbon dioxide laser treatment of a burn scar is a more effective method for improving the appearance of scars than the current available treatments.

Condition or disease Intervention/treatment
Scars Device: Lumenis fractional carbon dioxide laser

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Burn Scar Characteristics After Treatment With Fractional CO2 Laser: A Clinical and Histological Study
Study Start Date : December 2009
Primary Completion Date : September 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Scars
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Laser treatment
Half of each subject's scar will be treated with a fractional CO2 laser.
Device: Lumenis fractional carbon dioxide laser
Laser resurfacing of a burn scar
Other Name: Lumenis
No Intervention: No treatment
Half of each subject's scar will not be treated.


Outcome Measures

Primary Outcome Measures :
  1. Evidence of clinical improvement of burn scar appearance as determined by blinded-observer and patient ratings. [ Time Frame: 2 weeks after each procedure ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have a mature burn scar and desire revision
  • Fluent in English
  • Must reside in the Los Angeles vicinity for the duration of the study

Exclusion Criteria:

  • Previous history of scar revision
  • Non-English speakers
  • Pregnant or cognitively impaired subjects
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969215


Locations
United States, California
Moy-Fincher Medical Group
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Moy-Fincher Medical Group
Investigators
Principal Investigator: David Ozog, MD Moy-Fincher Medical Group
More Information

Responsible Party: Ronald Moy, MD, Moy-Fincher Medical Group
ClinicalTrials.gov Identifier: NCT00969215     History of Changes
Other Study ID Numbers: MF-02
First Posted: September 1, 2009    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011

Keywords provided by Moy-Fincher Medical Group:
burn scar
fractional carbon dioxide laser
scar revision