Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia

The Safety and Efficacy of Fractional Ablative 10, 600nm CO2 Laser-assisted Treatments for Male Pattern Hair Loss: a Randomized Cohort Study Comparing Stand-alone Laser Treatment, Laser Assisted Drug Delivery of Minoxidil 2% Solution , and Laser Assisted Drug Delivery of Minoxidil 2% Solution Plus Self-administration of Minoxidil 5% at Home.

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.

Study Overview

• Status: Withdrawn
• Conditions: Androgenetic Alopecia; Male Pattern Baldness; Male Pattern Hair Loss
• Intervention / Treatment: Device: Laser; Drug: Post-laser 5mg minoxidil; Drug: Post-laser 10mg minoxidil; Drug: Post-laser 20mg minoxidil; Drug: Post-Laser Minoxidil 2%; Drug: At-Home Minoxidil 5%

Detailed Description

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 be required. Additionally, this study will assist in understanding the effects of stand-alone laser therapy on hair growth and may also be used as a background or framework for a growing number of studies investigating this technology as a drug delivery system.

MPHL, also known as androgenetic alopecia, is a non-scarring alopecia resulting in gradual hair loss localized to the scalp. In men, this progressive hair loss disorder results in characteristic thinning of hair over the vertex and frontal regions.1 The Hamilton-Norwood scale categorizes this typical clinical progression.2 While the pathogenesis of MPHL is not entirely elucidated, it has been proposed to be an age and hormone dependent process with dihydrotestosterone playing a significant role.2,3 Genetic factors may also contribute to the disease.4

Topical minoxidil is an FDA approved treatment for MPHL. Minoxidil 2 and 5% solution are known to increase hair regrowth in men with androgenetic alopecia.7 While the mechanism remains unknown, it has been proposed minoxidil increases the duration of anagen and vascular supply to the follicular structure.8

Topical treatments for MPHL such as minoxidil have limited efficacy, as topical delivery of medication has low bioavailability.9 With the advent of fractionated ablative and non-ablative laser technologies, more efficient drug delivery to the level of the superficial epidermis and dermis is now possible.

The outermost layer of skin, the stratum corneum, impedes the diffusion of topical medications to follicular structures in the dermis and hypodermis. 9 Ablative fractionated laser devices create vertical channels, permitting topical medication to breach the skin's top layer, the stratum corneum, and reach deep skin layers where hair follicles reside.9

Both ablative and non-ablative fractionated laser treatments augment collagen deposition and cause growth factor mediated changes to skin ultrastructure.10 Non-ablative fractionated laser therapy in MPHL patients improves hair density with and without topical administration of growth factor.10 Our proposed study confers an additional mode of treatment beyond laser-only therapy by using an ablative fractionated laser to deliver minoxidil 2% solution percutaneously.

Herein, the investigators seek to further optimize patient treatment by investigating a combination of these treatment modalities for management of MPHL. The investigators hypothesize that fractionated ablative 10,600nm CO2 laser treatment and laser assisted drug delivery of minoxidil 2% solution will result in increased hair growth. With this improved clinical outcome and increased treatment efficiency, patient quality of life will be enhanced and fewer at home topical treatments may be required.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ronda S. Farah, MD; Phone Number: 763-898-1000; Email: rfarah@umn.edu
• Study Contact Backup: Name: James T. Pathoulas; Phone Number: 612-626-4454; Email: jpathoul@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
      • Contact: Ronda Farah, MD; Phone Number: 612-625-8625; Email: rfarah@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safety Group; will participate in one visit, receiving laser assisted delivery of minoxidil and PK data. The safety group treatments will follow dose escalation as follows: Safety Participant 1: Post-laser 5mg minoxidil (0.25ml of 20mg/ml sterile solution, applied post-laser procedure); Safety Participant 2: Post-laser 10mg minoxidil (0.5ml of 20mg/ml sterile solution, applied post-laser procedure); Safety Participant 3: Post-laser 20mg minoxidil (1mL of 20mg/mL sterile solution, applied post-laser procedure)	Device: Laser; Fractional ablative, deep mode, 5% fractional coverage; Drug: Post-laser 5mg minoxidil; 0.25ml of 20mg/ml sterile solution, applied post-laser procedure; Other Names: Rogaine; Drug: Post-laser 10mg minoxidil; 0.5ml of 20mg/ml sterile solution, applied post-laser procedure; Other Names: Rogaine; Drug: Post-laser 20mg minoxidil; 1ml of 20mg/ml sterile solution, applied post-laser procedure; Other Names: Rogaine
Placebo Comparator: Placebo; Laser: Fractional ablative, deep mode, 5% fractional coverage Post-Laser Saline 0.9%: 2ml of sterile saline solution applied post-laser procedure	Device: Laser; Fractional ablative, deep mode, 5% fractional coverage
Experimental: Treatment A; Laser: Fractional ablative, deep mode, 5% fractional coverage Post-Laser Minoxidil 2%: 2ml of 20mg/ml sterile solution, applied post-laser procedure	Drug: Post-Laser Minoxidil 2%; 2ml of 20mg/ml sterile solution, applied post-laser procedure; Other Names: Rogaine
Experimental: Treatment B; Laser: Fractional ablative, deep mode, 5% fractional coverage Post-Laser Minoxidil 2%: 2ml of 20mg/ml sterile solution, applied post-laser procedure At-Home Minoxidil 5%: 2ml of 50mg/ml foam q24 h for duration of study	Drug: Post-Laser Minoxidil 2%; 2ml of 20mg/ml sterile solution, applied post-laser procedure; Other Names: Rogaine; Drug: At-Home Minoxidil 5%; 2ml of 50mg/ml foam q24 h for duration of study; Other Names: Rogaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair Growth Assessment (HGA)	Scale indicating graded degree of change represented as no change, worse outcome, better outcome.	End of trial (8-16 weeks)
Hair Growth Index (HGI)	Hair growth is compared from baseline by three self-report questions on a health outcome questionnaire	End of trial (8-16 weeks)
Change in Hair Growth Satisfaction Scale (HGSS)	Hair appearance/growth is compared from baseline by five self-report questions that rank satisfaction with hair growth on a scale from -3 (very dissatisfied) to 3 (very satisfied).	Week 0, Week 4(+4), Week 8(+4)
Change in Investigator Global Assessment of Photography	Scale from -3 (significant worsening) to 3 (significant improvement) assessing hair loss/growth	Week 0, end of trial (8-16 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Additional Investigator Global Assessment of Photography	Scale from -3 (significant worsening) to 3 (significant improvement) assessing hair loss/growth	Week 0, end of trial (8-16 weeks)
Change in Scalp Symptom Assessments	Measure 4 criteria, erythema, scaling, pruritis, and burning/stinging, on a scale from 0 (none) to 4 (severe)	Week 0, Week 4(+4), Week 8(+4)

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2022
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): July 1, 2023

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Baldness; Androgenetic Alopecia; Male Pattern Hair Loss; Male Baldness; Bald
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: DERM-2018-27024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes