ScarsNCT04567537
Laser Treatment for the Improvement of Scars and Scleroderma
A study testing Laser Treatment in people with Scars and Scleroderma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In this study, the investigators seek to evaluate the effects of a laser treatment on the redistribution/regeneration of collagen on the clinical, microscopic, and molecular profiles of hypertrophic scars and scleroderma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scars, Scleroderma
- What is being tested?
- Laser Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2021to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
- In good general health, based on answers provided during the screening visit;
- Subject must be able to read and understand English;
- Any gender and any Fitzpatrick skin type;
- Age equal to or greater than 18 years old;
- Subjects in the hypertrophic scar branch must have at least one extragenital hypertrophic scar (defined as abnormal proliferation of scar tissue that forms at the site of cutaneous injury and does not regress and grows beyond the original margins of the scar) large enough to treat for both the control and experimental arm (at least 4cm in length for spit scar treatment) or two similar hypertrophic scars (at least 4cm2 for each);
- Subjects in the scleroderma branch must have eligible extragenital lesions; large enough to treat for both the control and experimental arm or two similar scleroderma areas (at least 4cm2 area for each);
Who cannot join
- Participation in another investigational drug or device clinical trial in the past 30 days;
- Are pregnant or lactating;
- Use of any prescription or in-clinic medications or treatments, such as intralesional corticosteroids or excision, on the eligible scars/scleroderma in the previous 3 months;
- History of allergic reaction to topical or local anesthesia;
- Regular intake of high doses of anti-inflammatory drugs (aspirin >81 mg/day, ibuprofen, corticosteroids, etc.) or immunosuppressive drugs;
- Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Clinical Unit for Research Trials & Outcomes in Skin
Boston, Massachusetts, 02114
About this study
Official title: Ablative Fractional Laser Treatment for the Improvement of Hypertrophic Scars and Scleroderma: a Prospective Cohort Study
In this study, the investigators seek to evaluate the effects of a laser treatment on the redistribution/regeneration of collagen on the clinical, microscopic, and molecular profiles of hypertrophic scars and scleroderma.
Read the detailed description
This study is designed to evaluate the efficacy of laser treatment for the improvement of the clinical appearance of disorders of collagen metabolism, including hypertrophic scars and scleroderma. The investigators will be performing a prospective cohort study. The entire lesion will receive laser treatment only.
The investigators plan to have 20 patients (10 patients with hypertrophic scars and 10 patients with scleroderma) complete the study.
Subjects must be equal to greater than 18 years old, but may be any gender or Fitzpatrick skin type. They must have one of the following: at least one extragenital hypertrophic scar, or at least one extragenital area of scleroderma . Subjects must not have received any prescription or in-clinic medications or treatments, such as intralesional corticosteroids or excision, on the eligible scars/scleroderma in the previous 3 months. Those on anti-inflammatory or immunosuppressive medications will also be excluded.
- Conditions
- Scars, Scleroderma
- Being tested
- Laser Treatment
- Keywords
- Scar, Scleroderma, Laser
- Medical subject headings
- Cicatrix, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TreatmentDevice
Patients will receive three laser treatments at one-month intervals.
| Study group | Role | What they receive |
|---|---|---|
| Scars | Active comparator | The entire hypertrophic scar will receive laser treatment only. Receives: Device: Laser Treatment |
| Scleroderma | Active comparator | The entire lesion will receive laser treatment. Receives: Device: Laser Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vancouver Scar Scale Score Post-Treatment
The Vancouver Scar Scale (VSS) is a clinical assessment tool used by healthcare professionals to evaluate the severity and characteristics of scars. It helps clinicians measure how abnormal a scar is compared with normal skin and track changes over time or with treatment.
The total score range is 0-13 where a score of 0 indicates normal skin (no abnormal scarring), and a higher score indicates more severe scar features. Therefore, a negative change in Vancouver Score Scale (VCC) post-treatment indicates that the scar improved.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start2 Jun 2021
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Why it stopped: Recruitment has been slow and we are prioritizing other studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ScarsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will be performing a prospective cohort study, where the entire lesion will receive laser treatment.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dieter Manstein, MD, Massachusetts General Hospital
- Investigators
- Dieter Manstein, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567537
- Sponsor's protocol ID
- 2019P002156
- Status last verified
- Mar 2026
- First submitted
- 11 Sep 2020
- Last updated
- 3 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablative Fractional Laser Treatment for the Improvement of Hypertrophic Scars and Scleroderma: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04567537
- Acronym / sponsor ID
- 2019P002156
- Conditions
- Scars, Scleroderma
- Keywords
- Scar, Scleroderma, Laser
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment has been slow and we are prioritizing other studies.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Posted 3 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators seek to evaluate the effects of a laser treatment on the redistribution/regeneration of collagen on the clinical, microscopic, and molecular profiles of hypertrophic scars and scleroderma.
Detailed description
This study is designed to evaluate the efficacy of laser treatment for the improvement of the clinical appearance of disorders of collagen metabolism, including hypertrophic scars and scleroderma. The investigators will be performing a prospective cohort study. The entire lesion will receive laser treatment only.
The investigators plan to have 20 patients (10 patients with hypertrophic scars and 10 patients with scleroderma) complete the study.
Subjects must be equal to greater than 18 years old, but may be any gender or Fitzpatrick skin type. They must have one of the following: at least one extragenital hypertrophic scar, or at least one extragenital area of scleroderma . Subjects must not have received any prescription or in-clinic medications or treatments, such as intralesional corticosteroids or excision, on the eligible scars/scleroderma in the previous 3 months. Those on anti-inflammatory or immunosuppressive medications will also be excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will be performing a prospective cohort study, where the entire lesion will receive laser treatment.
| Arm | Type | Receives |
|---|---|---|
| Scars | Active comparator | Device: Laser TreatmentThe entire hypertrophic scar will receive laser treatment only. |
| Scleroderma | Active comparator | Device: Laser TreatmentThe entire lesion will receive laser treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
- In good general health, based on answers provided during the screening visit;
- Subject must be able to read and understand English;
- Any gender and any Fitzpatrick skin type;
- Age equal to or greater than 18 years old;
Key exclusion criteria (6 listed)
- Participation in another investigational drug or device clinical trial in the past 30 days;
- Are pregnant or lactating;
- Use of any prescription or in-clinic medications or treatments, such as intralesional corticosteroids or excision, on the eligible scars/scleroderma in the previous 3 months;
- History of allergic reaction to topical or local anesthesia;
- Regular intake of high doses of anti-inflammatory drugs (aspirin >81 mg/day, ibuprofen, corticosteroids, etc.) or immunosuppressive drugs;
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 TreatmentPatients will receive three laser treatments at one-month intervals. | Device | Scars, Scleroderma |
Primary outcome
Change in Vancouver Scar Scale Score Post-Treatment
Time frame: 4 months
The Vancouver Scar Scale (VSS) is a clinical assessment tool used by healthcare professionals to evaluate the severity and characteristics of scars. It helps clinicians measure how abnormal a scar is compared with normal skin and track changes over time or with treatment. The total score range is 0-13 where a score of 0 indicates normal skin (no abnormal scarring), and a higher score indicates more severe scar features. Therefore, a negative change in Vancouver Score Scale (VCC) post-treatment indicates that the scar improved.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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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.
Dieter Manstein, MD, PhD 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 Laser Treatment in people with Scars and Scleroderma, 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 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: stopped early, as of the sponsor's last update on 3 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?
Yes. Results are posted in the registry (first posted 3 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Vancouver Scar Scale Score Post-Treatment (time frame: 4 months). 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 3 Apr 2026.