Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

The objective of this study is to evaluate the safety and efficacy of fractionated ablative 10,600nm CO2 laser assisted delivery of 2% minoxidil solution in the treatment of MPHL. In this cohort study, patients will randomly be assigned stand-alone laser treatment, laser assisted drug delivery of minoxidil 2% solution, and laser assisted drug delivery of minoxidil 2% solution plus at home 5% minoxidil treatment. The primary endpoints will be to assess the change from baseline in investigator and subject Hair Growth Assessments (HGA), Hair Growth Index (HGI) and the Hair Growth Satisfaction Scale (HGSS) over 8-12 weeks in each of the three groups. The secondary endpoints will be expert assessment of hair density from baseline and evaluation of safety and adverse events, and pharmacokinetic (PK) data.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Minoxidil; Pharmaceutical Solutions

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.