Laser Treatment for the Improvement of Scars and Scleroderma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ablative Fractional Laser Treatment for the Improvement of Hypertrophic Scars and Scleroderma: a Prospective Cohort Study

Conditions
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Scars, Scleroderma

Intervention / Treatment
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* Device: Laser Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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); Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators will be performing a prospective cohort study, where the entire lesion will receive laser treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Scars<br>The entire hypertrophic scar will receive laser treatment only. | Device: Laser Treatment<br>* Patients will receive three laser treatments at one-month intervals.<br>|
| Active Comparator: Scleroderma<br>The entire lesion will receive laser treatment. | Device: Laser Treatment<br>* Patients will receive three laser treatments at one-month intervals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's Global Assessment Scale | A score of 0 denotes No evidence of disease, 100% improvement and Completely clear. A score of 1 denotes Very significant clearance (≥90% to 100%); only traces of disease remain and Almost Clear. A score of 2 denotes Significant improvement(≥75% to < 90%); some evidence of disease remains and Marked Improvement. A score of 3 denotes Intermediate between slight and marked improvement (≥50% to <75%) and Moderate Improvement. A score of 4 denotes Some improvement (≥25% to <50%); significant evidence of disease remains and Slight Improvement . A score of 5 denotes Disease has not changed from baseline (+ or - <25%) and No Change. A score of 6 denotes Disease is worse than at baseline by ≥25% or more and Worse. | baseline, pre-intervention | 
| Physician's Global Assessment Scale | A score of 0 denotes No evidence of disease, 100% improvement and Completely clear. A score of 1 denotes Very significant clearance (≥90% to 100%); only traces of disease remain and Almost Clear. A score of 2 denotes Significant improvement(≥75% to < 90%); some evidence of disease remains and Marked Improvement. A score of 3 denotes Intermediate between slight and marked improvement (≥50% to <75%) and Moderate Improvement. A score of 4 denotes Some improvement (≥25% to <50%); significant evidence of disease remains and Slight Improvement . A score of 5 denotes Disease has not changed from baseline (+ or - <25%) and No Change. A score of 6 denotes Disease is worse than at baseline by ≥25% or more and Worse. | 1 month after baseline | 
| Physician's Global Assessment Scale | A score of 0 denotes No evidence of disease, 100% improvement and Completely clear. A score of 1 denotes Very significant clearance (≥90% to 100%); only traces of disease remain and Almost Clear. A score of 2 denotes Significant improvement(≥75% to < 90%); some evidence of disease remains and Marked Improvement. A score of 3 denotes Intermediate between slight and marked improvement (≥50% to <75%) and Moderate Improvement. A score of 4 denotes Some improvement (≥25% to <50%); significant evidence of disease remains and Slight Improvement . A score of 5 denotes Disease has not changed from baseline (+ or - <25%) and No Change. A score of 6 denotes Disease is worse than at baseline by ≥25% or more and Worse. | 2 months after baseline | 
| Physician's Global Assessment Scale | A score of 0 denotes No evidence of disease, 100% improvement and Completely clear. A score of 1 denotes Very significant clearance (≥90% to 100%); only traces of disease remain and Almost Clear. A score of 2 denotes Significant improvement(≥75% to < 90%); some evidence of disease remains and Marked Improvement. A score of 3 denotes Intermediate between slight and marked improvement (≥50% to <75%) and Moderate Improvement. A score of 4 denotes Some improvement (≥25% to <50%); significant evidence of disease remains and Slight Improvement . A score of 5 denotes Disease has not changed from baseline (+ or - <25%) and No Change. A score of 6 denotes Disease is worse than at baseline by ≥25% or more and Worse. | 3 months after baseline | 
| Physician's Global Assessment Scale | A score of 0 denotes No evidence of disease, 100% improvement and Completely clear. A score of 1 denotes Very significant clearance (≥90% to 100%); only traces of disease remain and Almost Clear. A score of 2 denotes Significant improvement(≥75% to < 90%); some evidence of disease remains and Marked Improvement. A score of 3 denotes Intermediate between slight and marked improvement (≥50% to <75%) and Moderate Improvement. A score of 4 denotes Some improvement (≥25% to <50%); significant evidence of disease remains and Slight Improvement . A score of 5 denotes Disease has not changed from baseline (+ or - <25%) and No Change. A score of 6 denotes Disease is worse than at baseline by ≥25% or more and Worse. | 4 months after baseline | 
| Physician's Global Assessment Scale | A score of 0 denotes No evidence of disease, 100% improvement and Completely clear. A score of 1 denotes Very significant clearance (≥90% to 100%); only traces of disease remain and Almost Clear. A score of 2 denotes Significant improvement(≥75% to < 90%); some evidence of disease remains and Marked Improvement. A score of 3 denotes Intermediate between slight and marked improvement (≥50% to <75%) and Moderate Improvement. A score of 4 denotes Some improvement (≥25% to <50%); significant evidence of disease remains and Slight Improvement . A score of 5 denotes Disease has not changed from baseline (+ or - <25%) and No Change. A score of 6 denotes Disease is worse than at baseline by ≥25% or more and Worse. | Up to 1 year after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mouth Handicap in Systemic Sclerosis scale | To assess facial scleroderma | Compare baseline to post-procedural | 
| Vancouver Scar Scale | To assess all scars, facial and non-facial | Compare baseline to post-procedural | 
| Range of Motion Evaluation | For non-facial scleroderma to evaluate range of motion of the joint by assessing flexion, extension, supination, and pronation using a goniometer | Compare baseline to post-procedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scar, Scleroderma, Laser