Pilot Study of the Effect of Laser on Reversing Chronic Radiation Injury (NCT01910818) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pilot Study of the Effect of Laser on Reversing Chronic Radiation Injury
United States12 participantsStarted 2013-11
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Active tanning, including the use of tanning booths, during the course of the study;
✕
What they're measuring
1
Improvement in fibrosis (% reduction in fibrosis surface area) compared to controlled sites
. 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;