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Laser Therapy

Fractional CO2 Laser for Burn Scars

N/A
Recruiting
Led By Jonathan Friedstat, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must already be planning to undergo laser treatment for their burn scar
Patient must be willing to undergo biopsy procedures
Must not have
Medical Conditions that preclude laser treatment
The study scar must not be adjacent to/in continuity with areas of HTBS that are planning to be treated with surgical interventions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 months
Awards & highlights

Summary

This trial aims to understand why laser treatment reduces pain & itch associated with hypertrophic burn scars.

Who is the study for?
This trial is for individuals with hypertrophic burn scars that are painful, itchy, or hypersensitive. Participants must have had the burn within the last two years and be planning to undergo laser treatment. They should agree to biopsies and a year of follow-up. Pregnant individuals or those on certain medications like steroids, antihistamines, pain relief drugs, or those affecting wound healing cannot join.Check my eligibility
What is being tested?
The study tests how effective Fractional CO2 laser therapy (Luminis ultrapulse) is in reducing pain and itchiness in hypertrophic burn scars. It involves histological evaluations over different stages of treatment to understand the underlying mechanisms behind symptom improvement.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of laser application, skin redness, swelling, changes in skin pigmentation, scarring from biopsies taken during the study process and possible allergic reactions to topical or local anesthetics used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am planning to have laser treatment for my burn scar.
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I am willing to have biopsy procedures.
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My burn injury happened within the last 2 years.
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I have a thickened burn scar treated with skin grafts or healed on its own.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any health issues that prevent me from getting laser treatment.
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My study scar is not near areas needing surgery.
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I have epilepsy or a seizure disorder.
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I am not taking any medications that could affect wound healing.
Select...
I have had laser or surgical treatment for a thick burn scar.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Histological change in nerve density
Histological change in nerve morphology
Secondary outcome measures
Symptomatic Improvement Assessment

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Laser treatment to 3x3cm2 area. It will receive the Luminous ultra pulse fractional ablative carbon dioxide laser at 150mJ, 3% density and 250Hz

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,955 Previous Clinical Trials
13,212,650 Total Patients Enrolled
Jonathan Friedstat, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Luminis Ultrapulse Fractional Ablative Carbon Dioxide Laser (Laser Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04364217 — N/A
Hypertrophic Scar Research Study Groups: Treatment
Hypertrophic Scar Clinical Trial 2023: Luminis Ultrapulse Fractional Ablative Carbon Dioxide Laser Highlights & Side Effects. Trial Name: NCT04364217 — N/A
Luminis Ultrapulse Fractional Ablative Carbon Dioxide Laser (Laser Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04364217 — N/A
~3 spots leftby Mar 2025
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