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Laser Therapy
Laser Treatment for Radiation Dermatitis
N/A
Waitlist Available
Led By Richard R Anderson, 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
Having suitable areas of treatment: All wounds in the area of interest must be closed for at least two months. The scars must be deemed stable for a period of 3 months or have a suitable contralateral control before initiation of treatment. This will be determined by objective measurements of scar erythema, pliability, induration, thickness at enrollment and again at 3 months;
Be older than 18 years old
Must not have
Having any form of active cancer at the time of enrollment and during the course of the study;
History of collagen vascular disease;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether fractional laser treatment can improve the appearance and function of skin in people who have chronic radiation dermatitis from cancer treatment.
Who is the study for?
This trial is for healthy adults aged 18-80 with chronic skin damage from radiation, including fibrosis and depigmentation that occurred at least a year ago. Pregnant women can join as there are no new drugs involved. Participants must not have active cancer, be on certain chemotherapies, or have conditions affecting the study's safety.
What is being tested?
The study tests if Fractional CO2 laser treatment (FLT) can reverse chronic skin damage caused by radiation therapy compared to no treatment. FLT aims to remodel scar tissue and restore normal skin functions in patients with long-term radiation dermatitis.
What are the potential side effects?
While specific side effects of FLT aren't listed here, similar treatments may cause redness, swelling, pain at the site of application, changes in pigmentation, and a risk of infection or scarring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My treatment area wounds have been closed for 2 months, and scars are stable or have a matching area to compare.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any active cancer besides the one being studied.
Select...
I have a history of collagen vascular disease.
Select...
I have a history of immune system problems or take medication that weakens my immune system.
Select...
I do not have active Herpes or more than three outbreaks in the past year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Improvement in fibrosis (% reduction in fibrosis surface area) compared to controlled sites
Secondary study objectives
Adverse events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: No TreatmentExperimental Treatment1 Intervention
This is the area receiving no treatment.
Group II: Fractional CO2 laser TreatmentExperimental Treatment1 Intervention
This is the area getting treated with CO2 laser.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,270 Total Patients Enrolled
1 Trials studying Radiation Dermatitis
34 Patients Enrolled for Radiation Dermatitis
Richard R Anderson, MDPrincipal InvestigatorMassachusetts General Hospital
4 Previous Clinical Trials
89 Total Patients Enrolled
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