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Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03852992
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief 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.

Condition or disease Intervention/treatment Phase
Male Pattern Hair Loss Androgenetic Alopecia Male Pattern Baldness Drug: Post-Laser Minoxidil 2% Drug: At-Home Minoxidil 5% Device: Laser Drug: Post-laser 5mg minoxidil Drug: Post-laser 10mg minoxidil Drug: Post-laser 20mg minoxidil Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

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 Name: Rogaine

Drug: Post-laser 10mg minoxidil
0.5ml of 20mg/ml sterile solution, applied post-laser procedure
Other Name: Rogaine

Drug: Post-laser 20mg minoxidil
1ml of 20mg/ml sterile solution, applied post-laser procedure
Other Name: 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 Name: 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 Name: Rogaine

Drug: At-Home Minoxidil 5%
2ml of 50mg/ml foam q24 h for duration of study
Other Name: Rogaine




Primary Outcome Measures :
  1. Hair Growth Assessment (HGA) [ Time Frame: End of trial (8-16 weeks) ]
    Scale indicating graded degree of change represented as no change, worse outcome, better outcome.

  2. Hair Growth Index (HGI) [ Time Frame: End of trial (8-16 weeks) ]
    Hair growth is compared from baseline by three self-report questions on a health outcome questionnaire

  3. Change in Hair Growth Satisfaction Scale (HGSS) [ Time Frame: Week 0, Week 4(+4), Week 8(+4) ]
    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).

  4. Change in Investigator Global Assessment of Photography [ Time Frame: Week 0, end of trial (8-16 weeks) ]
    Scale from -3 (significant worsening) to 3 (significant improvement) assessing hair loss/growth


Secondary Outcome Measures :
  1. Change in Additional Investigator Global Assessment of Photography [ Time Frame: Week 0, end of trial (8-16 weeks) ]
    Scale from -3 (significant worsening) to 3 (significant improvement) assessing hair loss/growth

  2. Change in Scalp Symptom Assessments [ Time Frame: Week 0, Week 4(+4), Week 8(+4) ]
    Measure 4 criteria, erythema, scaling, pruritis, and burning/stinging, on a scale from 0 (none) to 4 (severe)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852992


Contacts
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Contact: Ronda S. Farah, MD 763-898-1000 rfarah@umn.edu
Contact: James T. Pathoulas 612-626-4454 jpathoul@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ronda Farah, MD    612-625-8625    rfarah@umn.edu   
Sponsors and Collaborators
University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03852992    
Other Study ID Numbers: STUDY00004080_1
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Minnesota:
Male Pattern Hair Loss
Androgenetic Alopecia
Male Baldness
Bald
Baldness
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Vasodilator Agents