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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01910818
Recruitment Status : Recruiting
First Posted : July 30, 2013
Last Update Posted : January 10, 2017
Information provided by (Responsible Party):
Richard Rox Anderson, MD, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Radiation Dermatitis Device: Fractional CO2 laser treatment Other: No treatment Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Understanding and Reversing Chronic Radiation Dermatitis - A Pilot Study
Study Start Date : November 2013
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fractional CO2 laser Treatment
This is the area getting treated with CO2 laser.
Device: Fractional CO2 laser treatment
Patient will be treated with fractional laser treatment over the areas with fibrosis.
Other Name: Lumenis Ultrapulse CO2 laser
Experimental: No Treatment
This is the area receiving no treatment.
Other: No treatment
Patient will also have an area that is not being treated with CO2 laser. This is the area not getting treatment.

Primary Outcome Measures :
  1. Improvement in fibrosis (% reduction in fibrosis surface area) compared to controlled sites [ Time Frame: 6-12 months ]
    The primary end point is % reduction of the fibrosis surface area compared to control sites at 6-12 months.

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 2 years ]
    Measurement adverse events (infection, scarring, ulceration, excessive bleeding, poor wound healing)

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy males and females between 18 and 70 years of age with radiation-induced fibrosis and depigmentation. The fibrosis must have occurred at least 1 year prior to the date of enrollment.
  2. Having suitable areas of treatment: All wounds in the area of interest must be closed for at least two months. The scars must be deemed stable for a period of 3 months or have a suitable contralateral control before initiation of treatment. This will be determined 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 and requirements;
  5. Able to understand and provide written informed consent;
  6. Pregnant woman can be included because study involves local intervention, no new drugs.

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 three months of initial treatment or during the course of the study;
  3. Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists;
  4. History of collagen vascular disease;
  5. Active Herpes Simplex or Zoster at the time of treatment or having experienced more than three episodes of Herpes Simplex / Zoster eruption within a year of study enrollment;
  6. History of immunosuppression/immune deficiency disorders (including human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) or use of immunosuppressive medications;
  7. Having any form of active cancer at the time of enrollment and during the course of the study;
  8. Significant concurrent illness, such as uncontrolled diabetes (with a hemoglobin A1C of more than 8) (i.e., any disease state that in the opinion of the Investigator would interfere 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 the subject 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 the muscles, 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 an investigational drug within past 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01910818

Contact: Richard R Anderson, MD 617-726-3308
Contact: Thanh-Nga Tran, MD PhD 617-724-4937

United States, Massachusetts
Wellman Center for Photomedicine, Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Richard R Anderson, MD    617-726-3308   
Contact: Thanh-Nga T Tran, MD PhD    617-724-4937   
Principal Investigator: Richard R Anderson, MD         
Sub-Investigator: Thanh-Nga T. Tran, MD PhD         
Sub-Investigator: Yen-Lin Chen, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Richard R Anderson, MD Massachusetts General Hospital

Responsible Party: Richard Rox Anderson, MD, Director, Wellman Center for Photomedicine, Massachusetts General Hospital Identifier: NCT01910818     History of Changes
Other Study ID Numbers: 2013P000988
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Richard Rox Anderson, MD, Massachusetts General Hospital:

Additional relevant MeSH terms:
Skin Diseases
Radiation Injuries
Wounds and Injuries
Hair Diseases
Pathological Conditions, Anatomical