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Procedure

Laser Treatment for Scars and Scleroderma

N/A
Waitlist Available
Led By Neera Nathan, MD, MSHS
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects in the hypertrophic scar branch must have at least one extragenital hypertrophic 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)
Must not have
Regular intake of high doses of anti-inflammatory drugs (aspirin >81 mg/day, ibuprofen, corticosteroids, etc.) or immunosuppressive drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year after baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether a laser treatment can improve the appearance of hypertrophic scars and scleroderma.

Who is the study for?
Adults over 18, willing to consent and follow study rules, in good health based on screening, who can read English. They must have a large hypertrophic scar or scleroderma lesions suitable for treatment. Pregnant individuals, recent trial participants, those using certain medications/treatments for scars/scleroderma, with allergies to anesthetics or taking high doses of anti-inflammatory/immunosuppressive drugs cannot join.
What is being tested?
The study is testing how effective laser treatment is at improving the appearance and condition of hypertrophic scars and scleroderma by promoting collagen redistribution/regeneration. It will look at clinical outcomes as well as microscopic and molecular changes.
What are the potential side effects?
While not explicitly listed here, common side effects of laser treatments may include redness, swelling, itching at the treatment site; temporary pigment changes; slight bruising; risk of skin infection; rarely scarring or burns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a large scar or two similar scars suitable for treatment.
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I have scleroderma with lesions or areas large enough for treatment.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I regularly take high doses of anti-inflammatory or immunosuppressive drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Physician's Global Assessment Scale
Secondary study objectives
Mouth Handicap in Systemic Sclerosis scale
Range of Motion Evaluation
Vancouver Scar Scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: SclerodermaActive Control1 Intervention
The entire lesion will receive laser treatment.
Group II: ScarsActive Control1 Intervention
The entire hypertrophic scar will receive laser treatment only.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,262 Total Patients Enrolled
Neera Nathan, MD, MSHSPrincipal InvestigatorMassachusetts General Hospital
3 Previous Clinical Trials
71 Total Patients Enrolled
Dieter Manstein, MD, PhDPrincipal Investigator - Massachusetts General Hospital
Dermatology Associate, Massachusetts General Hospital
Westfalische Wilhelms-University (Medical School)
5 Previous Clinical Trials
114 Total Patients Enrolled

Media Library

Laser Treatment (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04567537 — N/A
Scleroderma Research Study Groups: Scleroderma, Scars
Scleroderma Clinical Trial 2023: Laser Treatment Highlights & Side Effects. Trial Name: NCT04567537 — N/A
Laser Treatment (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04567537 — N/A
~0 spots leftby Dec 2024
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