Burn ScarNCT03197649
CO2 Laser Phototherapy for Management of Mature Burn Scars
A study testing Laser phototherapy treatment in people with Burn Scar, run by University of California, Davis at 1 site in United States.
Trial summary
Evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Burn Scar
- What is being tested?
- Laser phototherapy treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 29 Apr 2019
- 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 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 3 to 21
- Patients with mature burn scars that are at least two years old from burn injury and that have not previously undergone CO2 laser therapy for scar revision.
- Scars in all body areas with the exception of face, genitals or hands will be considered eligible for the study
- Entry into this study is open to pediatric patients of both genders.
- Entry into this study is open to pediatric patients of all ethnic backgrounds.
- Entry into this study is open to females of childbearing potential with a negative urine or serum pregnancy test
Who cannot join
- Patients with scars less than 2 years old
- Patients with contraindications to laser treatment (i.e.: active acne infections/ treatment with isotretinoin, active Zoster infection)
- Patients receiving other forms of scar revision therapy such as other laser types, steroid injections, or surgical excisions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children
Sacramento, California, 95817
About this study
Official title: Randomized, Prospective, Split Scar Pilot Study to Evaluate the Efficacy of CO2 Laser Phototherapy for Management of Mature Burn Scars
Evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.
Read the detailed description
Laser phototherapy has gained growing acceptance and popularity for management of burn scars. The most commonly used laser is the Carbon Dioxide (CO2) Laser. At this institution, the investigator has used CO2 for management of Burn Scars since 2012. While the existing literature and the investigator's anecdotal experience thus far has been positive overall, there is no conclusive evidence to support that CO2 does indeed improve the quality of mature burn scars
The primary objective of this study is to evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.
- Conditions
- Burn Scar
- Being tested
- Laser phototherapy treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser phototherapy treatmentProcedure or surgery
Laser phototherapy treatment administered in OR
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No laser phototherapy treatment |
| Laser phototherapy treatment | Experimental | Laser phototherapy treatment administered in OR Receives: Procedure: Laser phototherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scar assessment evaluation
Patient and Observer Scar Assessment Scale
Measured: Prior to initial treatment and no sooner than 3 months following last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start22 May 2017
- Primary completion29 Apr 2019
- Study completion29 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn ScarStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- The study patient will have one portion of their scar, measuring 5x5 cms (or 50% of the scar, for scars smaller than 5x10 cms) left untreated at the time of the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Responsible party
- Sponsor
- Investigators
- Pirko Maguina, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197649
- Sponsor's protocol ID
- 950482
- Status last verified
- Jul 2020
- First submitted
- 14 Jun 2017
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective, Split Scar Pilot Study to Evaluate the Efficacy of CO2 Laser Phototherapy for Management of Mature Burn Scars
- ClinicalTrials.gov ID
- NCT03197649
- Acronym / sponsor ID
- 950482
- Conditions
- Burn Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Study start
- 22 May 2017 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 23 Jun 2017 (actual)
- 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.
Evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.
Detailed description
Laser phototherapy has gained growing acceptance and popularity for management of burn scars. The most commonly used laser is the Carbon Dioxide (CO2) Laser. At this institution, the investigator has used CO2 for management of Burn Scars since 2012. While the existing literature and the investigator's anecdotal experience thus far has been positive overall, there is no conclusive evidence to support that CO2 does indeed improve the quality of mature burn scars
The primary objective of this study is to evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study patient will have one portion of their scar, measuring 5x5 cms (or 50% of the scar, for scars smaller than 5x10 cms) left untreated at the time of the study.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No laser phototherapy treatment |
| Laser phototherapy treatment | Experimental | Procedure: Laser phototherapy treatmentLaser phototherapy treatment administered in OR |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 3 to 21
- Patients with mature burn scars that are at least two years old from burn injury and that have not previously undergone CO2 laser therapy for scar revision.
- Scars in all body areas with the exception of face, genitals or hands will be considered eligible for the study
- Entry into this study is open to pediatric patients of both genders.
- Entry into this study is open to pediatric patients of all ethnic backgrounds.
Key exclusion criteria (3 listed)
- Patients with scars less than 2 years old
- Patients with contraindications to laser treatment (i.e.: active acne infections/ treatment with isotretinoin, active Zoster infection)
- Patients receiving other forms of scar revision therapy such as other laser types, steroid injections, or surgical excisions.
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 |
|---|---|---|
| Laser phototherapy treatmentLaser phototherapy treatment administered in OR | Procedure or surgery | Laser phototherapy treatment |
Primary outcome
Change in scar assessment evaluation
Time frame: Prior to initial treatment and no sooner than 3 months following last treatment
Patient and Observer Scar Assessment Scale
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 16 Jul 2020.
- Individual participant dataSharing planned: No. No plan
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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.
Pirko Maguina, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser phototherapy treatment in people with Burn Scar, run by University of California, Davis 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 6 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 16 Jul 2020. 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?
Change in scar assessment evaluation (time frame: Prior to initial treatment and no sooner than 3 months following last treatment). 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 16 Jul 2020.