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 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT03852992
Eligibility Criteria:
Inclusion Criteria:
1. Males ages 21-65 years old with MPHL
2. Norwood III vertex-V. The vertex scalp must be involved
3. MPHL diagnosed by a board-certified dermatologist
4. Willing to abstain from use of over the counter products and prescription products other than those supplied in the study
5. Willing to abstain from the use of non-steroidal anti-inflammatory medications, aspirin, St. Johns Wart, and high doses of Vitamin E supplementation
6. Subjects must be capable of giving informed consent
7. Willing to adhere to protocol, including scalp examinations and photography
Exclusion Criteria:
1. Allergy or intolerance to minoxidil
2. Underlying disease that might be adversely affected by minoxidil.
3. Immunosuppressed patients (history of transplantation, cancer, chemotherapy, splenectomy, HIV)
4. Application of topical immunomodulatory or immunosuppressive agent in the preceding 6 weeks
5. Systemic administration of corticosteroid or other systemic treatment (e.g. prednisone) that has immunomodulatory or other immunosuppressive mechanism of action, in the preceding 8 weeks or planned usage at any time throughout the study
6. Clinical evidence of secondary skin infection (e.g. folliculitis)
7. Other inflammatory or infectious skin disease that might interfere with evaluations during the study
8. Investigational medications within the past 30 days
9. Severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies
10. Oral retinoids within the past 6 months and topical retinoid usage within the past 4 weeks
11. Patients with history of or susceptible to keloid formation
12. Finasteride or dutasteride within the past 6 weeks
13. Spironolactone within the past 6 weeks
14. Active infection
15. Lesions in the treated area suspicious for malignancy
16. Known allergy to hair dye or hair dye components
17. Relevant history of hypotension
18. Hypertension that is untreated or uncontrolled
19. Radiation or chemotherapy to the site
20. Use of topical or oral ketoconazole in the past 6 weeks
21. Hair transplants or weaves
22. Other concomitant types of history of hair loss such as telogen effluvium
23. Medical problems including HIV, connective tissue disorder, PCOS, untreated thyroid disease
24. Psychiatric disease that that may increase risks within the trial
25. Current use of tanning beds or any active tanning
26. Use of antihypertensives or vasodilators following a first-time diagnosis of hypertension within the past 6 months
27. Planned upcoming surgeries
28. Tattoo on scalp
29. Use of oral minoxidil within the past 6 months
30. History of orthostatic hypotension
31. Adults lacking capacity to consent
32. Adults who do not speak English.
33. A medical history or clinical evidence of: acute myocardial infarction, angina, cardiac disease, cardiac tamponade, cerebrovascular disease, coronary artery disease, hypotension, orthostatic hypotension, pericardial effusion, peripheral edema, heart failure, pulmonary hypertension, renal disease, renal failure, renal impairment, pregnancy, breast-feeding, children, pheochromocytoma, skin abrasion, and geriatric.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT03852992
Study Brief:
Protocol Section:
NCT03852992