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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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.
- 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;
- Fitzpatrick skin types I-VI;
- Able and willing to comply with all visit, treatment and evaluation schedules andrequirements;
- Able to understand and provide written informed consent;
- Pregnant woman can be included because study involves local intervention, no newdrugs.
Exclusion
Exclusion Criteria:
- 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 threemonths of initial treatment or during the course of the study;
- 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;
- History of collagen vascular disease;
- 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;
- History of immunosuppression/immune deficiency disorders (including humanimmunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) oruse of immunosuppressive medications;
- Having any form of active cancer at the time of enrollment and during the course ofthe study;
- 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;
- 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;
- If it is determined that the contracture is due to a deeper process involving themuscles, 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 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
Connect with a study center
Wellman Center for Photomedicine, Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available

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