Laser Treatment for Radiation Dermatitis
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive fractional laser treatment (FLT) using the Lumenis Ultrapulse CO2 laser
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Monitoring for adverse events such as infection, scarring, and poor wound healing
Treatment Details
Interventions
- Fractional CO2 laser treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor