Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01910818
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01910818
Study Brief:
Protocol Section:
NCT01910818