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Recruitment has been slow and we are prioritizing other studies.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scars | Active Comparator | The entire hypertrophic scar will receive laser treatment only. |
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| Scleroderma | Active Comparator | The entire lesion will receive laser treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Treatment | Device | Patients will receive three laser treatments at one-month intervals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dieter Manstein, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Clinical Unit for Research Trials & Outcomes in Skin | Boston | Massachusetts | 02114 | United States |
There is no plan to make individual participant data (IPD) available to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypertrophic Scar | Subjects in this group have hypertrophic scars which are thick, raised scars that form after the skin heals from an injury, such as a cut, burn, surgery, or piercing. It happens when the body produces too much collagen while repairing the skin. |
| FG001 | Scleroderma | Subject in this group have scleroderma, a chronic autoimmune disease that causes the body to produce too much collagen, leading to fibrosis (thickening and hardening of the tissue). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
4 participants completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Scars | The entire hypertrophic scar will receive laser treatment only. Laser Treatment: Patients will receive three laser treatments at one-month intervals. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | score on a scale | 4 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Scars | The entire hypertrophic scar will receive laser treatment only. Laser Treatment: Patients will receive three laser treatments at one-month intervals. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-inflammatory hyperpigmentation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | subject experienced minor post-inflammatory hyperpigmentation after laser procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dieter Manstein | Massachusetts General Hospital | 6177264454 | mansteinlab@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2023 | Mar 11, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012595 | Scleroderma, Systemic |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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The investigators will be performing a prospective cohort study, where the entire lesion will receive laser treatment.
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Vancouver Scar Scale | 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. | Number | number on a scale |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
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| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |