Pilot Study of the Effect of Laser on Reversing Chronic Radiation Injury

Last updated: November 1, 2023
Sponsor: Massachusetts General Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Allergy

Hair Loss

Rash

Treatment

Fractional CO2 laser treatment

No treatment

Clinical Study ID

NCT01910818
2013P000988
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Inclusion

Inclusion Criteria:

  1. Healthy males and females between 18 and 80 years of age with radiation-inducedfibrosis and depigmentation. The fibrosis must have occurred at least 1 year prior tothe date of enrollment.
  2. Having suitable areas of treatment: All wounds in the area of interest must be closedfor at least two months. The scars must be deemed stable for a period of 3 months orhave a suitable contralateral control before initiation of treatment. This will bedetermined by objective measurements of scar erythema, pliability, induration,thickness at enrollment and again at 3 months;
  3. Fitzpatrick skin types I-VI;
  4. Able and willing to comply with all visit, treatment and evaluation schedules andrequirements;
  5. Able to understand and provide written informed consent;
  6. Pregnant woman can be included because study involves local intervention, no newdrugs.

Exclusion

Exclusion Criteria:

  1. Active tanning, including the use of tanning booths, during the course of the study;
  2. Prior skin treatment with laser or other devices in the treated area within threemonths of initial treatment or during the course of the study;
  3. Adverse reactions to compounds of any external agent (e.g., gels, lotions oranesthetic creams) required for use in the study, if no alternative to the said agentexists;
  4. History of collagen vascular disease;
  5. Active Herpes Simplex or Zoster at the time of treatment or having experienced morethan three episodes of Herpes Simplex / Zoster eruption within a year of studyenrollment;
  6. History of immunosuppression/immune deficiency disorders (including humanimmunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) oruse of immunosuppressive medications;
  7. Having any form of active cancer at the time of enrollment and during the course ofthe study;
  8. Significant concurrent illness, such as uncontrolled diabetes (with a hemoglobin A1Cof more than 8) (i.e., any disease state that in the opinion of the Investigator wouldinterfere with the anesthesia, treatment, or healing process); Mentally incompetent,prisoner or evidence of active substance or alcohol abuse;
  9. Any condition which, in the Investigator's opinion, would make it unsafe (for thesubject or study personnel) to treat the subject as part of this research study;
  10. If it is determined that the contracture is due to a deeper process involving themuscles, ligaments or bones.
  11. Patient on chemotherapy (but not tamoxifen or other things that affect wound healing)and also active XRT
  12. Participation in another interventional study with potential exposure to aninvestigational drug within past 30 days

Study Design

Total Participants: 12
Treatment Group(s): 2
Primary Treatment: Fractional CO2 laser treatment
Phase:
Study Start date:
November 01, 2013
Estimated Completion Date:
August 31, 2026

Study Description

We propose to treat 22 patients with significant radiation induced fibrosis (RIF) and skin changes. Each patient will receive fractional treatment (FLT) using the Lumenis Ultrapulse Carbon Dioxide (CO2) laser as well as control (no treatment) randomized to site. Patient age, type of cancer, method/dosage of radiation, latency between radiation treatment and start of study, and characteristics of skin changes will be recorded, including fibrosis surface area, depth, color, and compliance. Assessments will be conducted before each treatment, after each treatment, and 3-12 months after the last treatment.

Connect with a study center

  • Wellman Center for Photomedicine, Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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