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

NCT01910818 | Active Not Recruiting DMC

• 1 other identifier: 2013P000988
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Radiation Dermatitis

Keywords

radiation; dermatitis; laser; fractional; CO2; chronic; fibrosis; scar

Outcome Measures

Primary Outcomes (1)

• Improvement in fibrosis (% reduction in fibrosis surface area) compared to controlled sites

  The primary end point is % reduction of the fibrosis surface area compared to control sites at 6-12 months.

  6-12 months

Secondary Outcomes (1)

• Adverse events

  2 years

Study Arms (2)

Fractional CO2 laser Treatment

EXPERIMENTAL

This is the area getting treated with CO2 laser.

Device: Fractional CO2 laser treatment

No Treatment

EXPERIMENTAL

This is the area receiving no treatment.

Other: No treatment

Interventions

Fractional CO2 laser treatment DEVICE

Patient will be treated with fractional laser treatment over the areas with fibrosis.

Also known as: Lumenis Ultrapulse CO2 laser

Fractional CO2 laser Treatment

No treatment OTHER

Patient will also have an area that is not being treated with CO2 laser. This is the area not getting treatment.

No Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males and females between 18 and 80 years of age with radiation-induced fibrosis and depigmentation. The fibrosis must have occurred at least 1 year prior to the date of enrollment.
• 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;
• Fitzpatrick skin types I-VI;
• Able and willing to comply with all visit, treatment and evaluation schedules and requirements;
• Able to understand and provide written informed consent;
• Pregnant woman can be included because study involves local intervention, no new drugs.

You may not qualify if:

• Active tanning, including the use of tanning booths, during the course of the study;
• 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;
• 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;
• History of collagen vascular disease;
• 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;
• History of immunosuppression/immune deficiency disorders (including human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) or use of immunosuppressive medications;
• Having any form of active cancer at the time of enrollment and during the course of the study;
• 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;
• 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;
• If it is determined that the contracture is due to a deeper process involving the muscles, ligaments or bones.
• Patient on chemotherapy (but not tamoxifen or other things that affect wound healing) and also active XRT
• Participation in another interventional study with potential exposure to an investigational drug within past 30 days

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Wellman Center for Photomedicine, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• clinical trials

MeSH Terms

Conditions

Dermatitis; Bronchiolitis Obliterans Syndrome; Fibrosis; Cicatrix

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard R Anderson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Wellman Center for Photomedicine

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: July 30, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 2, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)