Status:
ACTIVE_NOT_RECRUITING
Pilot Study of the Effect of Laser on Reversing Chronic Radiation Injury
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Chronic Radiation Dermatitis
Eligibility:
All Genders
18-70 years
Phase:
NA
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 mo...
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 (CO...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01910818
Start Date
November 1 2013
End Date
August 1 2026
Last Update
November 2 2023
Active Locations (1)
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1
Wellman Center for Photomedicine, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114