Scars, Scleroderma
Conditions
Keywords
Scar, Scleroderma, Laser
Brief 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.
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.
Interventions
DEVICELaser Treatment
Patients will receive three laser treatments at one-month intervals.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The investigators will be performing a prospective cohort study, where the entire lesion will receive laser treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol; 2. In good general health, based on answers provided during the screening visit; 3. Subject must be able to read and understand English; 4. Any gender and any Fitzpatrick skin type; 5. Age equal to or greater than 18 years old; 6. 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); 7. 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);
Exclusion criteria
1. Participation in another investigational drug or device clinical trial in the past 30 days; 2. Are pregnant or lactating; 3. 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; 4. History of allergic reaction to topical or local anesthesia; 5. Regular intake of high doses of anti-inflammatory drugs (aspirin \>81 mg/day, ibuprofen, corticosteroids, etc.) or immunosuppressive drugs; 6. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vancouver Scar Scale Score Post-Treatment | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDieter Manstein, MD, PhD
Massachusetts General Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
| Vancouver Scar Scale Subject 1 | 8 number on a scale |
| Vancouver Scar Scale Subject 2 | 8 number on a scale |
| Vancouver Scar Scale Subject 3 | 6 number on a scale |
| Vancouver Scar Scale Subject 4 | 9 number on a scale |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 1 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
None listed