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 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT02521402
Eligibility Criteria:
Inclusion Criteria:
The subject has:
1. been diagnosed with a keloid scar
2. a keloid scar that is located on the face, neck, arm, trunk, or groin area
3. is between the ages of 21 and 80 years old
4. competency as an adult, per applicable state law who is willing to provide written informed consent
5. the intent and ability to return for all scheduled and required visits and follow recommended standard post surgical treatment for keloid scar excision.
Exclusion Criteria:
The subject has:
1. clinical evidence of infection of the keloid scar
2. any malignancy or a neoplasm at the keloid scar site
3. any significant comorbid disease that may interfere with wound healing, known active Hepatitis A, B, or C or Acquired Immune Deficiency Syndrome or is known to be infected with HIV, a known collagen disorder or autoimmune disease \[including systemic lupus erythematosis (SLE), rheumatoid arthritis (RA),fibromyalgia, polymyositis, scleroderma, ankylosing spondylitis, dermatomyositis, osteogenesis imperfecta or the inherited disorders of Sjogren, Larsen, Raynaud, Ehlers-Danlos or Marfan syndrome\]
4. received chemotherapy, radiotherapy, immunosuppressives or corticosteroids (greater than 10 mg prednisone-equivalent per day) within the past 30 days.
5. a known history of abuse of alcohol or drugs (prescribed or illegal), significant psychiatric personality or psychotic disorder requiring chronic psychotropic therapy, or gross noncompliance to recommended therapies
6. condition(s) that would adversely affect subject safety by following the protocol
7. any contraindication for use of Biovance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT02521402
Study Brief:
Protocol Section:
NCT02521402