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:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT04018859
Eligibility Criteria:
Inclusion Criteria:
1. Males or females 18-85 years old.
2. Subjects are in good health as judged by the investigator.
3. Patients with mild to moderate eyebrow hypotrichosis (modified GEyA grades of 3 and 4 at the time of screening, see Appendix A).
4. Those who have less eyebrows and therefore, desire to enhance eyebrows (modified GEyA grades of 3 and 4 at the time of screening, see Appendix A).
5. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator
Exclusion Criteria:
1. Patients with uncontrolled systemic disease (including alopecia areata or any other form of alopecia) which could inhibit hair growth
2. Patients with thrombocytopenia, platelet dysfunction, hypofibrinogenemia, anemia, cancer, active infections with Pseudomonas, Klebsiella, or Enterococcus, history of trichotillomania, thyroid diseases, eye diseases, atopic dermatitis, seborrheic dermatitis, lupus erythematosus, scleroderma, leprosy, or syphilis.
3. Patients who have started used agents that may affect eyebrow hair growth (e.g. minoxidil or bimatoprost) within 6 months of screening. Patients who have been using agents that may affect eyebrow hair growth for at least 12 months may be included if the patient agrees to continue their current dosing regimen for the duration of the study.
4. Known disease, infection, or abnormality in the treatment area or hair shaft
5. Patients with tattoos, scars, hyperpigmentation, or other features which could prevent accurate evaluation of hair growth in the eyebrow area.
6. Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments
7. Unwilling to refrain from washing face or using face care products 24 hours before and after treatment visits
8. History of a clinically significant hematologic disorder as determined by the investigator.
9. Subjects currently receiving anticoagulant or anti-platelet therapy.
10. Subject is known to be HIV positive.
11. Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, etc.
12. Pregnant or breast feeding
13. Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
14. Subjects who are unable to understand the protocol or give informed consent (including non-English speaking patients).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04018859
Study Brief:
Protocol Section:
NCT04018859