Back to resultsBurn Scar Appearance After Treatment With Fractional Carbon Dioxide (CO2) Laser
Primary Purpose
Scars
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumenis fractional carbon dioxide laser
Sponsored by
About this trial
This is an interventional treatment trial for Scars focused on measuring burn scar, fractional carbon dioxide laser, scar revision
Eligibility 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
Sites / Locations
- Moy-Fincher Medical Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Laser treatment
No treatment
Arm Description
Half of each subject's scar will be treated with a fractional CO2 laser.
Half of each subject's scar will not be treated.
Outcomes
Primary Outcome Measures
Evidence of clinical improvement of burn scar appearance as determined by blinded-observer and patient ratings.
Secondary Outcome Measures
Full Information
NCT ID
NCT00969215
First Posted
August 29, 2009
Last Updated
July 24, 2011
Sponsor
Moy-Fincher Medical Group
1. Study Identification
Unique Protocol Identification Number
NCT00969215
Brief Title
Burn Scar Appearance After Treatment With Fractional Carbon Dioxide (CO2) Laser
Official Title
Burn Scar Characteristics After Treatment With Fractional CO2 Laser: A Clinical and Histological Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Moy-Fincher Medical Group
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scars
Keywords
burn scar, fractional carbon dioxide laser, scar revision
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laser treatment
Arm Type
Experimental
Arm Description
Half of each subject's scar will be treated with a fractional CO2 laser.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Half of each subject's scar will not be treated.
Intervention Type
Device
Intervention Name(s)
Lumenis fractional carbon dioxide laser
Other Intervention Name(s)
Lumenis
Intervention Description
Laser resurfacing of a burn scar
Primary Outcome Measure Information:
Title
Evidence of clinical improvement of burn scar appearance as determined by blinded-observer and patient ratings.
Time Frame
2 weeks after each procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ozog, MD
Organizational Affiliation
Moy-Fincher Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moy-Fincher Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Burn Scar Appearance After Treatment With Fractional Carbon Dioxide (CO2) Laser
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