ScarsNCT00969215
Burn Scar Appearance After Treatment With Fractional Carbon Dioxide (CO2) Laser
A study testing Lumenis fractional carbon dioxide laser in people with Scars, run by Moy-Fincher Medical Group at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Scars
- What is being tested?
- Lumenis fractional carbon dioxide laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a mature burn scar and desire revision
- Fluent in English
- Must reside in the Los Angeles vicinity for the duration of the study
Who cannot join
- Previous history of scar revision
- Non-English speakers
- Pregnant or cognitively impaired subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
Moy-Fincher Medical Group
Los Angeles, California, 90095
About this study
Official title: Burn Scar Characteristics After Treatment With Fractional CO2 Laser: A Clinical and Histological Study
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.
- Conditions
- Scars
- Being tested
- Lumenis fractional carbon dioxide laser
- Keywords
- burn scar, fractional carbon dioxide laser, scar revision
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumenis fractional carbon dioxide laserDevice
Also called Lumenis
Laser resurfacing of a burn scar
| Study group | Role | What they receive |
|---|---|---|
| Laser treatment | Experimental | Half of each subject's scar will be treated with a fractional CO2 laser. Receives: Device: Lumenis fractional carbon dioxide laser |
| No treatment | No intervention | Half of each subject's scar will not be treated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinical improvement of burn scar appearance as determined by blinded-observer and patient ratings.
Measured: 2 weeks after each procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startDec 2009
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moy-Fincher Medical Group
- Sponsor type
- University, hospital or other
- Investigators
- David Ozog, MD, Principal investigator, Moy-Fincher Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969215
- Sponsor's protocol ID
- MF-02
- Status last verified
- Jul 2011
- First submitted
- 29 Aug 2009
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burn Scar Characteristics After Treatment With Fractional CO2 Laser: A Clinical and Histological Study
- ClinicalTrials.gov ID
- NCT00969215
- Acronym / sponsor ID
- MF-02
- Conditions
- Scars
- Keywords
- burn scar, fractional carbon dioxide laser, scar revision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Moy-Fincher Medical GroupUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser treatment | Experimental | Device: Lumenis fractional carbon dioxide laserHalf of each subject's scar will be treated with a fractional CO2 laser. |
| No treatment | No intervention | –Half of each subject's scar will not be treated. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a mature burn scar and desire revision
- Fluent in English
- Must reside in the Los Angeles vicinity for the duration of the study
Key exclusion criteria (3 listed)
- Previous history of scar revision
- Non-English speakers
- Pregnant or cognitively impaired subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumenis fractional carbon dioxide laserAlso: LumenisLaser resurfacing of a burn scar | Device | Laser treatment |
Primary outcome
Evidence of clinical improvement of burn scar appearance as determined by blinded-observer and patient ratings.
Time frame: 2 weeks after each procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ozog, MD principal investigator
Moy-Fincher Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumenis fractional carbon dioxide laser in people with Scars, run by Moy-Fincher Medical Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of clinical improvement of burn scar appearance as determined by blinded-observer and patient ratings. (time frame: 2 weeks after each procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2011.