Laser Treatment for the Improvement of Scars and Scleroderma

Scleroderma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04567537
• Other study ID #: 2019P002156
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2, 2021
• Est. completion date: May 2024

Study information

• Verified date: January 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Scars
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

Device:
• Laser Treatment
Patients will receive three laser treatments at one-month intervals.

Locations

Country	Name	City	State
United States	MGH Clinical Unit for Research Trials & Outcomes in Skin	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Mouth Handicap in Systemic Sclerosis scale	To assess facial scleroderma	Compare baseline to post-procedural
Secondary	Vancouver Scar Scale	To assess all scars, facial and non-facial	Compare baseline to post-procedural
Secondary	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