Laser Treatment for Radiation Dermatitis

Recruiting in Palo Alto (17 mi)

Overseen ByRichard R Anderson, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?Radiotherapy, an essential modality in cancer treatment, frequently induces a fibrotic process in the skin which can lead to increased risk of malignancy, poor wound healing, pain and limitation of movement, and permanent loss of skin appendages with hyper/hypopigmentation, decreased sweating and xerosis, posing significant cosmetic and quality of life issues. Advances in laser therapy has led to the use of fractional laser treatment (FLT) to treat fibrosis associated with in hypertrophic scars and morphea, leading to tissue repair, scar remodeling. The investigators propose a pilot clinical study to test the hypothesis that FLT can normalize the fibrotic process and induce normal scar remodeling in patients affected by chronic radiation injury. Understanding and correcting this underlying fibrotic process can help restore normal skin functions in patients affected with chronic radiation dermatitis (RD) and other debilitating fibrotic diseases in dermatology such as scleroderma, morphea, or nephrogenic systemic fibrosis.

Eligibility Criteria

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.

Inclusion Criteria

My treatment area wounds have been closed for 2 months, and scars are stable or have a matching area to compare.

Exclusion Criteria

I do not have any active cancer besides the one being studied.

I have a history of collagen vascular disease.

I have a history of immune system problems or take medication that weakens my immune system.

I do not have active Herpes or more than three outbreaks in the past year.

Participant Groups

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.

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.