Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia

Launched by UNIVERSITY OF MINNESOTA · Feb 21, 2019

Keywords

ClinConnect Summary

Male pattern hair loss (MPHL) is a common, frustrating, and difficult to manage scalp disease with few treatment options available. Though the mechanism remains unclear, minoxidil is a well-established treatment for MPHL. With the advent of laser assisted drug delivery, the investigators seek to investigate the use of laser assisted minoxidil delivery to improve bioavailability, and subsequent hair growth for subjects MPHL. With an improved clinical outcome and increased treatment efficiency, patient quality of life would be enhanced and fewer at home topical treatments with minoxidil may b...

Gender

MALE

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.