Hypertrophic ScarNCT04364217
Pain and Itch Reduction in Burn Scars Treated With Fractional CO2 Laser
A study testing Luminis ultrapulse fractional ablative carbon dioxide laser in people with Hypertrophic Scar and Burn Scar, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Hypertrophic Burn Scars (HTBS) are often treated with Fractional CO2 laser therapy to improve cosmetic appearance. It has been noted that this leads to a reduction in the pain and itch associated with this type of scars. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertrophic Scar, Burn Scar
- What is being tested?
- Luminis ultrapulse fractional ablative carbon dioxide laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2020to Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have a hypertrophic burn scar treated by skin grafts or allowed to heal secondarily
- Burn must have occurred within the last 2 years from time of recruitment
- Patient must have symptoms of pain and/or itch and/or hypersensitivity in the hypertrophic burn scar area
- Patient must already be planning to undergo laser treatment for their burn scar
- Patient must be willing to undergo biopsy procedures
- Patient must be willing and able to participate in the study with a year of follow-up
- Not be pregnant or planning to become pregnant during the treatment phase of the study
Who cannot join
- Medical Conditions that preclude laser treatment
- Active tanning, including the use of tanning booths, during the course of the study
- Inability to complete surveys
- Previous laser (PDL, CO2), surgical reconstructive treatment procedures done on the hypertrophic burn scar
- Current treatment with other procedures or drugs (experimental or other) in area of interest
- Medications that interfere with wound healing (oral steroids, immunosuppressive medications, chemotherapy or other)
Show all 13Show fewer
- Medication for itch (steroids, antihistamines, or other)
- Medication for pain (opioids, topical pain treatment, gabapentin, ondasetron, paroxetine or other)
- Adverse reactions to topical or local anesthetic agents needed for this study, if no alternative to the said agent exists
- 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.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject
- Patient suffers from epilepsy or seizure disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Evaluating the Mechanism of Pain and Itch Reduction in Burn Scars Following Fractional Ablative CO2 Laser Treatment
Hypertrophic Burn Scars (HTBS) are often treated with Fractional CO2 laser therapy to improve cosmetic appearance. It has been noted that this leads to a reduction in the pain and itch associated with this type of scars. While this phenomenon is commonly described in the literature, the mechanism of pain and itch reduction in unclear. The investigators aim to better understand this process by histological evaluation of HTBS at different stages of laser treatment.
Read the detailed description
During our study, patients with painful and/or itchy burn scars will undergo standard treatment with fractional CO2 laser. In addition to the standard of care treatment, participants will undergo skin biopsies and be asked to complete Patient Reported Outcome Measure questionnaires related to their HTBS. Burn scars will also undergo standard and 3 dimensional photography at the different stages of treatment. Biopsy samples will undergo various staining techniques to establish the changes in tissue that occur with the laser treatment. This information will also be correlated with the symptomatic changes.
- Conditions
- Hypertrophic Scar, Burn Scar
- Being tested
- Luminis ultrapulse fractional ablative carbon dioxide laser
- Keywords
- Pain, Itch
- Medical subject headings
- Cicatrix, Hypertrophic, Pain, Pruritus
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 laserDevice
Also called Fractional CO2 laser treatment
This laser will target water molecules and ablate columns of tissue that are approximately 3mm deep.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Laser treatment to 3x3cm2 area. It will receive the Luminous ultra pulse fractional ablative carbon dioxide laser at 150mJ, 3% density and 250Hz Receives: Device: Luminis ultrapulse fractional ablative carbon dioxide laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological change in nerve density
The investigators will stain the collected skin with markers specific to nerves to in order to count the number of nerves per biopsy area.
Measured: 7 months
Histological change in nerve morphology
The investigators will stain the collected skin with markers specific to nerves to in order to compare the size and shape of cutaneous nerves before and after treatment. This will be based on subjective evaluation and not a predetermined scale.
Measured: 7 months
Secondary outcomes (1)
Symptomatic Improvement Assessment
Patient Reported Outcome Measures will be collected via the Patient and Observer Scar Assessment Scale (POSAS). This is a validated questionnaire that includes 5 physician-completed parameters and 6 patient-reported measures. Each parameter is rated from 1-10 with a score of 1 representing "skin that appears close to normal" and 10 representing the "worst scare imaginable". Overall, the final score will range from 11( best outcome) to 110 (worst outcome).
Physician parameters relate to the scar appearance such as color and thickness of the scar; while the patient-reported parameters also include symptomatic factors, such as degree of pain associated with the scar
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start25 Jun 2020
- Primary completionMar 2025 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: Difficulties in enrollment lead to withdrawing the study without enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- 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
- NCT04364217
- Sponsor's protocol ID
- 2019P003424
- Status last verified
- Dec 2025
- First submitted
- 6 Mar 2020
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Mechanism of Pain and Itch Reduction in Burn Scars Following Fractional Ablative CO2 Laser Treatment
- ClinicalTrials.gov ID
- NCT04364217
- Acronym / sponsor ID
- 2019P003424
- Conditions
- Hypertrophic Scar, Burn Scar
- Keywords
- Pain, Itch
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulties in enrollment lead to withdrawing the study without enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 28 Apr 2020 (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.
Hypertrophic Burn Scars (HTBS) are often treated with Fractional CO2 laser therapy to improve cosmetic appearance. It has been noted that this leads to a reduction in the pain and itch associated with this type of scars. While this phenomenon is commonly described in the literature, the mechanism of pain and itch reduction in unclear. The investigators aim to better understand this process by histological evaluation of HTBS at different stages of laser treatment.
Detailed description
During our study, patients with painful and/or itchy burn scars will undergo standard treatment with fractional CO2 laser. In addition to the standard of care treatment, participants will undergo skin biopsies and be asked to complete Patient Reported Outcome Measure questionnaires related to their HTBS. Burn scars will also undergo standard and 3 dimensional photography at the different stages of treatment. Biopsy samples will undergo various staining techniques to establish the changes in tissue that occur with the laser treatment. This information will also be correlated with the symptomatic changes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient must have a hypertrophic burn scar treated by skin grafts or allowed to heal secondarily
- Burn must have occurred within the last 2 years from time of recruitment
- Patient must have symptoms of pain and/or itch and/or hypersensitivity in the hypertrophic burn scar area
- Patient must already be planning to undergo laser treatment for their burn scar
- Patient must be willing to undergo biopsy procedures
Key exclusion criteria (13 listed)
- Medical Conditions that preclude laser treatment
- Active tanning, including the use of tanning booths, during the course of the study
- Inability to complete surveys
- Previous laser (PDL, CO2), surgical reconstructive treatment procedures done on the hypertrophic burn scar
- Current treatment with other procedures or drugs (experimental or other) in area of interest
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 laserAlso: Fractional CO2 laser treatmentThis laser will target water molecules and ablate columns of tissue that are approximately 3mm deep. | Device | Treatment |
Primary outcome
Histological change in nerve density
Time frame: 7 months
The investigators will stain the collected skin with markers specific to nerves to in order to count the number of nerves per biopsy area.
Histological change in nerve morphology
Time frame: 7 months
The investigators will stain the collected skin with markers specific to nerves to in order to compare the size and shape of cutaneous nerves before and after treatment. This will be based on subjective evaluation and not a predetermined scale.
1 secondary outcome
Symptomatic Improvement Assessment
Time frame: 7 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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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 in people with Hypertrophic Scar and Burn 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 7 inclusion and 13 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: withdrawn, as of the sponsor's last update on 31 Dec 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Histological change in nerve density (time frame: 7 months). The study lists 2 primary outcomes in all. 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 31 Dec 2025.