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 @ 12:13 PM
Ignite Modification Date:
2025-12-24 @ 12:13 PM
NCT ID:
NCT03048461
Eligibility Criteria:
Inclusion Criteria:
1. Males or females ≥ 18 years old and ≤55 years old
2. Subjects are in good health as judged by the investigator.
3. Diagnosed with by a dermatologist with moderate androgenetic alopecia.
4. Subject is seeking treatment for androgenetic alopecia.
5. Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year.
6. 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. Other than androgenetic alopecia, evidence of another skin condition affecting the treatment area that would interfere with clinical assessments.
2. Subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study.
3. Willing to refrain from washing hair or using hair product 24 hours before and after treatment visits
4. History of a clinically significant hematologic disorder as determined by the investigator.
5. Subjects currently receiving anticoagulant or anti-platelet therapy.
6. Subjects on daily Aspirin therapy for cardiovascular disease.
7. Subjects with chronic NSAID use, unable to wean off.
8. Subject is known to be HIV positive.
9. History of recurrent facial or labial herpes simplex infection
10. History of hypertrophic scars or keloids
11. Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, etc.
12. Subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent
13. Pregnant or breast feeding
14. Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
15. Subjects who are unable to understand the protocol or give informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03048461
Study Brief:
Protocol Section:
NCT03048461