12 Participants Needed

Laser Treatment for Radiation Dermatitis

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chemotherapy or immunosuppressive medications, you may not be eligible to participate.

What data supports the effectiveness of the treatment Fractional CO2 laser treatment for radiation dermatitis?

Research on similar laser treatments, like the pulsed dye laser, shows they can effectively improve skin conditions caused by radiation, such as telangiectasias (small, visible blood vessels). Additionally, photobiomodulation therapy, another type of laser treatment, has been found effective in managing radiation dermatitis in breast cancer patients.12345

Is laser treatment for radiation dermatitis safe for humans?

The studies reviewed focus on the effectiveness of laser treatments for radiation dermatitis, but they do not provide specific safety data for humans. However, laser treatments like photobiomodulation and pulsed dye laser have been used in clinical settings, suggesting a level of safety in their application.23467

How does fractional CO2 laser treatment differ from other treatments for radiation dermatitis?

Fractional CO2 laser treatment is unique because it combines fractional photothermolysis (a process that targets small areas of skin) with an ablative laser, allowing it to effectively treat skin damage with shorter recovery times and fewer side effects compared to traditional laser treatments. This makes it a promising option for conditions like radiation dermatitis, where there are limited standard treatments available.89101112

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.

Research Team

RR

Richard R Anderson, MD

Principal Investigator

Massachusetts General Hospital

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

I am pregnant and can join because the study does not involve new drugs.
My treatment area wounds have been closed for 2 months, and scars are stable or have a matching area to compare.
People with any type of skin color can participate.
See 3 more

Exclusion Criteria

I have a history of collagen vascular disease.
I have a history of immune system problems or take medication that weakens my immune system.
You have had bad reactions to any substances used in the study, like gels or lotions, and there are no other options available.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fractional laser treatment (FLT) using the Lumenis Ultrapulse CO2 laser

3-12 months
Assessments before each treatment and after each treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

6-12 months

Long-term follow-up

Monitoring for adverse events such as infection, scarring, and poor wound healing

2 years

Treatment Details

Interventions

  • Fractional CO2 laser treatment
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Findings from Research

A retrospective study of 490 fractional CO2 laser treatments in 374 patients showed that this method has a low incidence of adverse events (13.6%), making it a safe option for treating skin issues like wrinkles and scars.
The most common side effects included acneiform eruptions and herpes simplex outbreaks, but there were no reports of scarring or hypopigmentation, indicating a favorable safety profile compared to traditional laser treatments.
The adverse events of deep fractional CO(2): a retrospective study of 490 treatments in 374 patients.Shamsaldeen, O., Peterson, JD., Goldman, MP.[2011]
Fractionated CO(2) laser resurfacing effectively treats wrinkles, sun damage, and scars while offering shorter recovery times and fewer side effects compared to traditional CO(2) laser treatments.
This technique utilizes fractional photothermolysis with a 10,600-nm wavelength, expanding its applications and improving patient outcomes in skin rejuvenation.
Fractionated CO2 laser resurfacing: our experience with more than 2000 treatments.Hunzeker, CM., Weiss, ET., Geronemus, RG.[2016]

References

Effect of laser therapy on quality of life in patients with radiation-induced breast telangiectasias. [2020]
Radiation-induced Breast Telangiectasias Treated with the Pulsed Dye Laser. [2020]
Photobiomodulation for the management of radiation dermatitis: the DERMIS trial, a pilot study of MLS(®) laser therapy in breast cancer patients. [2018]
Photobiomodulation therapy for the prevention of acute radiation dermatitis in breast cancer patients undergoing hypofractioned whole-breast irradiation (LABRA trial). [2022]
Pulsed dye laser treatment of telangiectasia after radiotherapy for carcinoma of the breast. [2019]
6.Czech Republicpubmed.ncbi.nlm.nih.gov
Recommendation for preventive and therapeutic skin care of patients undergoing radiotherapy. [2022]
ONS Guidelines™ for Cancer Treatment-Related Radiodermatitis. [2021]
Clinical evaluation of the SmartSkin fractional laser for the treatment of photodamage and acne scars. [2009]
The adverse events of deep fractional CO(2): a retrospective study of 490 treatments in 374 patients. [2011]
10.United Statespubmed.ncbi.nlm.nih.gov
High- Versus Low-Density Fractional Laser in the Treatment of Hypertrophic Postburn Scars: A Randomized Clinical Trial. [2021]
Fractionated CO2 laser resurfacing: our experience with more than 2000 treatments. [2016]
12.United Statespubmed.ncbi.nlm.nih.gov
Effects of ablative 10,600-nm carbon dioxide fractional laser therapy on suppurative diseases of the skin: a case series of 12 patients. [2018]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security