Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia

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Brief Title

Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia

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.

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.
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Hair Growth Assessment (HGA)

Secondary Outcome

 Change in Additional Investigator Global Assessment of Photography

Condition

Male Pattern Hair Loss

Intervention

Post-Laser Minoxidil 2%

Study Arms / Comparison Groups

 Safety Group
Description:  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)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

48

Start Date

August 1, 2019

Completion Date

July 1, 2021

Primary Completion Date

July 1, 2021

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.
      

Gender

Male

Ages

21 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, 763-898-1000, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03852992

Organization ID

STUDY00004080_1


Responsible Party

Sponsor

Study Sponsor

University of Minnesota


Study Sponsor

, , 


Verification Date

August 2019