← Back to Search

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year after baseline

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have a large scar or two similar scars suitable for treatment.

Select...

I have scleroderma with lesions or areas large enough for treatment.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year after baseline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Physician's Global Assessment Scale

Secondary outcome measures

Mouth Handicap in Systemic Sclerosis scale

Range of Motion Evaluation

Vancouver Scar Scale

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,335 Total Patients Enrolled

1 Trials studying Scarring

8 Patients Enrolled for Scarring

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

106 Total Patients Enrolled

Media Library

Laser Treatment (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04567537 — N/A

Scarring Research Study Groups: Scleroderma, Scars

Scarring 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of individuals participating in this research project?

"Affirmative. According to clinicaltrials.gov, this research project is still enrolling participants and was initially made public on June 2nd 2021. The most recent update occurred on February 11th 2022; the study requires 20 patients from a single trial centre."

Answered by AI

Are there any available vacancies in this experiment for participants?

"Indeed, the information hosted on clinicaltrials.gov attests to this trial's ongoing recruitment process which commenced June 2nd 2021 and was recently updated February 11th 2022. Currently, 20 individuals are being sought out from a single medical centre for inclusion in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Laser Treatment for the Improvement of Scars and Scleroderma

Dieter Manstein, MD 2021. "Laser Treatment for the Improvement of Scars and Scleroderma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04567537.

All > Scleroderma Research Foundation > Scleroderma