Laser Treatment for the Improvement of Scars and Scleroderma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Scars; Scleroderma
• Intervention / Treatment: Device: Laser Treatment

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lais Clinical Research Coordinator; Phone Number: (617) 726-4454; Email: lgomes@mgh.harvard.edu
• Study Contact Backup: Name: Neera Nathan, MD, MSHS; Email: nnathan2@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • MGH Clinical Unit for Research Trials & Outcomes in Skin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Dieter Manstein, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Scar; Scleroderma; Laser
• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
• Other Study ID Numbers: 2019P002156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No