BurnsNCT03692273
Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar
A study testing Luminis ultrapulse fractional ablative carbon dioxide laser and 0.5mm punch biopsy in people with Burns and Hypertrophic Scar, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Laser treatment of hypertrophic burn scars has become increasingly popular for improving scarring in burn survivors. Despite its common use, there a gap in knowledge regrading randomized control trials that demonstrate whether the laser is beneficial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Hypertrophic Scar
- What is being tested?
- Luminis ultrapulse fractional ablative carbon dioxide laser and 0.5mm punch biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2019to 6 Oct 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 18 years of age or older
- Must be medically fit to undergo laser/reconstructive procedure
- Must have symptomatic HTBS for which they are already planning to undergo laser treatment. The symptomatic HTBSs may include the study scar area, but there must be other areas that the patient is getting treated with laser besides the study scar.
- The HTBS must have occurred from a burn injured area either treated by skin grafts or allowed to heal secondarily.
- Be willing and able to participate in the study with a year of follow-up
- Must be able to answer surveys on their own, and not rely on surrogates
Show all 15Show fewer
- Not be pregnant or planning to become pregnant during the treatment phase of the study
- Study Scar Inclusion Criteria:
- The study scar must be at least 3mm thick
- For Extremities, no surgical treatment can be performed on joint space above or below the target area
- If the study scar is over a joint, then no surgical treatments can occur to the body part above or below it
- When the study scar is on the trunk or neck, it must not be on continuity or adjacent to any area of planned surgical treatment.
- Study Scar Size: The study scar can either be within an area of homogenous HTBS or be an area of HTBS surrounded by normal tissue if it meets the following size criteria:
- Within HTBS For treatment areas within burn scars, it must be 65cm2 or larger to permit 3 treatment areas that are 3 x 3cm with a 1cm wide segment of untreated scar between it.
- Surrounded by normal tissue For treatment areas surrounded by normal skin, the treatment area must be 33cm2 or greater, contain similar 3x3cm treatment areas, and have intervening segments of 1cm of scar between treatment areas. A border around the scar, is not required here because it is surrounded by normal skin.
Who cannot join
- Previous laser or reconstructive procedures for the treatment of their HTBS in the study scar or adjacent tissue.
- Steroids, immunosuppressive medications, chemotherapy or other medications that can delay their wound healing/immune function.
- Medical Conditions that preclude laser treatment or general anesthesia if needed
- Cognitively unable to complete PROMs on their own
- The study area should not be part of a contracture or other hypertrophic scar that would be better treated with surgical procedures.
- The study scar must not be adjacent to/in continuity with areas of HTBS that are planning to be treated with surgical interventions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Within-Scar, Randomized Control Trial Comparing Fractional Ablative Carbon Dioxide Laser to Non-Energy-Based, Mechanical Tissue Extraction and No Treatment
Laser treatment of hypertrophic burn scars has become increasingly popular for improving scarring in burn survivors. Despite its common use, there a gap in knowledge regrading randomized control trials that demonstrate whether the laser is beneficial. Such a trial is important because if it shows the laser does work, it would provide the evidence to make such treatments more accessible to all patients.
Furthermore, there is no knowledge whether the burn injury used to remove tissue is beneficial or not. This study aims to evaluate the laser treatment, removal of similar tissue amounts with 0.5mm punch biopsies, to controls to fill this knowledge gap.
Read more
The hypothesis is the laser is beneficial at improving patient's burn scars. Also the punch biopsies work better at improving scars by removing tissue without burning and injuring the surrounding tissue as the laser does.
To evaluate these treatments (laser, punch biopsies, and no treatment), 3 small areas will be chosen in a study scar area that meets specific criteria to receive . Patients will still be able to receive laser and burn reconstruction procedures in all other areas not involving the study scar area that are clinically indicated.
In the study, the scar will be evaluated with photographs, surveys, and tissue samples taken either while under anesthesia except for one set taken with numbing medicine. The tissue samples will be looked at under a microscope to see how the treatments change the scar tissue. The tissue will also have tests done to evaluate how the laser impacts genes from cells in the scar tissue.
Lastly, to understand how reconstructive procedures (laser and surgical treatments) change a patient's quality of life, patients will be asked a limited set of questions to learn more how these procedures improve their lives.
- Conditions
- Burns, Hypertrophic Scar
- Being tested
- Luminis ultrapulse fractional ablative carbon dioxide laser, 0.5mm punch biopsy
- Medical subject headings
- Burns, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luminis ultrapulse fractional ablative carbon dioxide laserProcedure or surgery
This laser will target water molecules and ablate columns of tissue that are approximately 3mm deep.
0.5mm punch biopsyProcedure or surgery
punch biopsies will be performed to remove approximately equivalent volumes of tissue compared to the laser
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | Laser treatment to 3x3cm2 area. It will receive the Luminous ultra pulse fractional ablative carbon dioxide laser at 150mJ, 3% density and 250Hz. Receives: Procedure: Luminis ultrapulse fractional ablative carbon dioxide laser |
| 0.5mm punch biopsy | Experimental | 0.5mm punch biopsy area. This area will receive 0.5mm punch biopsies 75 per cm2 at a depth of 5mm. Receives: Procedure: 0.5mm punch biopsy |
| No treatment | No intervention | 3x3cm2 area designated as no treatment that will serve as a control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancouver Scar Scale
scar scale to evaluate severity of hypertrophic burn scars This is a 3 question scale, the first question graded from 0-3, the second and third questions graded from 0-5. The final score is the sum of the scores of the three questions, giving a possible total score range of 0-13. The higher the score, the worse the outcome.
Measured: 14 months (from first treatment to follow-up)
Secondary outcomes (4)
photography of treatment areas in scar for evaluation
Evaluation of photographs of the treatment areas in the study scar
Measured: 14 months (from first treatment to follow-up)
elasticity of treatment areas of scar
Measure elasticity using a cutometer
Measured: 14 months (from first treatment to follow-up)
histology of treatment areas of scar
tissue samples will be evaluates for changes in cell architecture, collagen, and cells within the scar
Measured: 14 months (from first treatment to follow-up)
Gene expression
Inflammatory gene expression will be evaluated between laser treatment and control tissue
Measured: 14 months (from first treatment to follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start20 Mar 2019
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will receive all three interventions (laser, 0.5mm punch biopsy, and no treatment) within their study scar.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Jonathan Friedstat, Massachusetts General Hospital
- Investigators
- Jonathan Friedstat, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692273
- Sponsor's protocol ID
- MB170043
- Status last verified
- Apr 2026
- First submitted
- 29 Sep 2018
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Within-Scar, Randomized Control Trial Comparing Fractional Ablative Carbon Dioxide Laser to Non-Energy-Based, Mechanical Tissue Extraction and No Treatment
- ClinicalTrials.gov ID
- NCT03692273
- Acronym / sponsor ID
- MB170043
- Conditions
- Burns, Hypertrophic Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 2 Oct 2018 (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.
Laser treatment of hypertrophic burn scars has become increasingly popular for improving scarring in burn survivors. Despite its common use, there a gap in knowledge regrading randomized control trials that demonstrate whether the laser is beneficial. Such a trial is important because if it shows the laser does work, it would provide the evidence to make such treatments more accessible to all patients.
Furthermore, there is no knowledge whether the burn injury used to remove tissue is beneficial or not. This study aims to evaluate the laser treatment, removal of similar tissue amounts with 0.5mm punch biopsies, to controls to fill this knowledge gap.
The hypothesis is the laser is beneficial at improving patient's burn scars. Also the punch biopsies work better at improving scars by removing tissue without burning and injuring the surrounding tissue as the laser does.
To evaluate these treatments (laser, punch biopsies, and no treatment), 3 small areas will be chosen in a study scar area that meets specific criteria to receive . Patients will still be able to receive laser and burn reconstruction procedures in all other areas not involving the study scar area that are clinically indicated.
In the study, the scar will be evaluated with photographs, surveys, and tissue samples taken either while under anesthesia except for one set taken with numbing medicine. The tissue samples will be looked at under a microscope to see how the treatments change the scar tissue. The tissue will also have tests done to evaluate how the laser impacts genes from cells in the scar tissue.
Lastly, to understand how reconstructive procedures (laser and surgical treatments) change a patient's quality of life, patients will be asked a limited set of questions to learn more how these procedures improve their lives.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will receive all three interventions (laser, 0.5mm punch biopsy, and no treatment) within their study scar.
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Procedure: Luminis ultrapulse fractional ablative carbon dioxide laserLaser treatment to 3x3cm2 area. It will receive the Luminous ultra pulse fractional ablative carbon dioxide laser at 150mJ, 3% density and 250Hz. |
| 0.5mm punch biopsy | Experimental | Procedure: 0.5mm punch biopsy0.5mm punch biopsy area. This area will receive 0.5mm punch biopsies 75 per cm2 at a depth of 5mm. |
| No treatment | No intervention | –3x3cm2 area designated as no treatment that will serve as a control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must be 18 years of age or older
- Must be medically fit to undergo laser/reconstructive procedure
- Must have symptomatic HTBS for which they are already planning to undergo laser treatment. The symptomatic HTBSs may include the study scar area, but there must be other areas that the patient is getting treated with laser besides the study scar.
- The HTBS must have occurred from a burn injured area either treated by skin grafts or allowed to heal secondarily.
- Be willing and able to participate in the study with a year of follow-up
Key exclusion criteria (6 listed)
- Previous laser or reconstructive procedures for the treatment of their HTBS in the study scar or adjacent tissue.
- Steroids, immunosuppressive medications, chemotherapy or other medications that can delay their wound healing/immune function.
- Medical Conditions that preclude laser treatment or general anesthesia if needed
- Cognitively unable to complete PROMs on their own
- The study area should not be part of a contracture or other hypertrophic scar that would be better treated with surgical procedures.
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 |
|---|---|---|
| Luminis ultrapulse fractional ablative carbon dioxide laserThis laser will target water molecules and ablate columns of tissue that are approximately 3mm deep. | Procedure or surgery | Laser |
| 0.5mm punch biopsypunch biopsies will be performed to remove approximately equivalent volumes of tissue compared to the laser | Procedure or surgery | 0.5mm punch biopsy |
Primary outcome
Vancouver Scar Scale
Time frame: 14 months (from first treatment to follow-up)
scar scale to evaluate severity of hypertrophic burn scars This is a 3 question scale, the first question graded from 0-3, the second and third questions graded from 0-5. The final score is the sum of the scores of the three questions, giving a possible total score range of 0-13. The higher the score, the worse the outcome.
4 secondary outcomes
photography of treatment areas in scar for evaluation
Time frame: 14 months (from first treatment to follow-up)
elasticity of treatment areas of scar
Time frame: 14 months (from first treatment to follow-up)
histology of treatment areas of scar
Time frame: 14 months (from first treatment to follow-up)
Gene expression
Time frame: 14 months (from first treatment to follow-up)
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Jonathan Friedstat, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luminis ultrapulse fractional ablative carbon dioxide laser and 0.5mm punch biopsy in people with Burns and Hypertrophic Scar, run by Massachusetts General Hospital 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 15 inclusion and 6 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 13 Apr 2026. 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?
Vancouver Scar Scale (time frame: 14 months (from first treatment to follow-up)). 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 13 Apr 2026.