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

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.

Inclusion Criteria:

1. 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.

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