Burn Scar Appearance After Treatment With Fractional Carbon Dioxide (CO2) Laser
This study has been completed.
Sponsor:
Moy-Fincher Medical Group
Information provided by:
Moy-Fincher Medical Group
ClinicalTrials.gov Identifier:
NCT00969215
First received: August 29, 2009
Last updated: July 24, 2011
Last verified: July 2011
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Purpose
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 | Intervention |
|---|---|
|
Scars |
Device: Lumenis fractional carbon dioxide laser |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Burn Scar Characteristics After Treatment With Fractional CO2 Laser: A Clinical and Histological Study |
Resource links provided by NLM:
Further study details as provided by Moy-Fincher Medical Group:
Primary Outcome Measures:
- Evidence of clinical improvement of burn scar appearance as determined by blinded-observer and patient ratings. [ Time Frame: 2 weeks after each procedure ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Ronald Moy, MD, Moy-Fincher Medical Group |
| ClinicalTrials.gov Identifier: | NCT00969215 History of Changes |
| Other Study ID Numbers: | MF-02 |
| Study First Received: | August 29, 2009 |
| Last Updated: | July 24, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Moy-Fincher Medical Group:
|
burn scar fractional carbon dioxide laser scar revision |
Additional relevant MeSH terms:
|
Cicatrix Fibrosis Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013