Laser Treatment for Radiation Dermatitis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Active cancer, Uncontrolled diabetes, Collagen vascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3-12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special type of laser treatment can improve skin problems caused by radiation therapy. The focus is on using a fractional CO2 laser to treat radiation-damaged skin, aiming to reduce scarring and restore normal skin function. Suitable candidates for this trial have undergone radiation treatment in the past year, resulting in scarring and skin color changes. Participants must have stable scars and no open wounds in the treatment area. Those with ongoing skin issues from recent tanning or other laser treatments do not qualify. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options for radiation-induced skin damage.

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 prior data suggests that this laser treatment is safe for radiation dermatitis?

Past studies have shown that fractional CO2 laser treatment is well-tolerated by most patients. Research indicates that this laser treatment effectively addresses skin issues like wrinkles, sun damage, and scars, often resulting in shorter recovery times and fewer side effects.

Some studies have reviewed hundreds of treatments and found that complications are rare. Common mild reactions include temporary redness, swelling, or acne, which usually resolve on their own. For safety, avoiding the laser is crucial if there's an active infection in the treatment area, as it could spread.

Overall, the fractional CO2 laser has been used safely in many patients and is considered a promising option for treating skin problems caused by radiation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fractional CO2 laser treatment is unique because it offers a different approach to managing radiation dermatitis compared to standard treatments like topical steroids and moisturizing creams. This laser treatment works by stimulating the skin's natural healing process, promoting the regeneration of damaged tissue, which is not something traditional treatments target directly. Researchers are excited about this because it has the potential to improve skin texture and reduce inflammation more effectively, possibly leading to faster and more noticeable recovery for patients suffering from radiation-induced skin damage.

What evidence suggests that fractional CO2 laser treatment might be an effective treatment for radiation dermatitis?

Studies have shown that fractional CO2 laser treatment, which participants in this trial may receive, can improve skin that has thickened and scarred, a common effect of radiation therapy. Research indicates that this laser treatment aids in tissue repair and scar reshaping, enhancing skin flexibility and appearance. In one study, patients experienced up to an 80% reduction in symptoms such as swelling and skin infections after several treatments. Another study found that combining the laser with a cream increased the treatment's effectiveness and tolerability. Overall, these findings suggest that fractional CO2 laser treatment can help manage skin problems caused by radiation. ^{4 5 6 7 8}

Who Is on the Research Team?

Richard R Anderson, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

People with any type of skin color can participate.

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: No Treatment Experimental Treatment 1 Intervention

This is the area receiving no treatment.

Group II: Fractional CO2 laser Treatment Experimental Treatment 1 Intervention

This is the area getting treated with CO2 laser.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractionated CO2 laser resurfacing: our experience with more than 2000 treatments. Hunzeker, CM., Weiss, ET., Geronemus, RG.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The adverse events of deep fractional CO(2): a retrospective study of 490 treatments in 374 patients. Shamsaldeen, O., Peterson, JD., Goldman, MP.[2011]

Citations

1.

jaad.org

jaad.org/article/S0190-9622(20)31945-9/fulltext

16935 Fractional CO2 laser therapy as a treatment for ...

Preliminary results show improved cosmesis, patient satisfaction and skin elasticity. While initial analysis indicates enhanced outcomes, we are conducting ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10366065/

Efficacy and Safety of Fractional CO2 Laser Combined with ...

The results from our study show that fractional CO2 laser combined with halometasone cream was an efficacious and well-tolerated treatment for ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10099494/

Laser therapy as a treatment for chronic radiation fibrosis

Fractional laser therapy has been shown to treat fibrosis associated with hypertrophic scars leading to tissue repair.

4.

researchgate.net

researchgate.net/publication/365260940_Laser_therapy_as_a_treatment_for_chronic_radiation_fibrosis

Laser therapy as a treatment for chronic radiation fibrosis

After six treatments of fractional CO2 laser, she noticed an 80% reduction of lymphorrea, swelling, and frequency of cellulitis. A 32‐year old melanoma patient ...

5.

withpower.com

withpower.com/trial/phase-radiodermatitis-10-2013-f44bf

Laser Treatment for Radiation Dermatitis · Info for Participants

Fractionated CO(2) laser resurfacing effectively treats wrinkles, sun damage, and scars while offering shorter recovery times and fewer side effects compared to ...

6.

researchgate.net

researchgate.net/publication/51494752_The_Adverse_Events_of_Deep_Fractional_CO2_A_Retrospective_Study_of_490_Treatments_in_374_Patients

A Retrospective Study of 490 Treatments in 374 Patients

Complications from fractional lasers, rare and evenly distributed among age groups and skin phototypes, include short-term erythema, edema, acne ...

7.

aetna.com

aetna.com/cpb/medical/data/400_499/0427.html

Carbon Dioxide Laser - Medical Clinical Policy Bulletins

Follow-up assessment of 40 patients 12 months after treatment revealed an excellent or good result in 74 % of adults and 53 % of children. The authors concluded ...

8.

scirp.org

scirp.org/journal/paperinformation?paperid=145441

Contraindications of Using Fractional CO2 Laser in the ...

The presence of an active infection in the treatment area constitutes an absolute contraindication to the application of fractional CO2 laser, as it may spread ...