Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia

NCT03852992 | Withdrawn Phase 2 FDA Drug FDA Device

• 1 other identifier: DERM-2018-27024
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Pattern Hair Loss; Androgenetic Alopecia; Male Pattern Baldness

Keywords

Male Pattern Hair Loss; Androgenetic Alopecia; Male Baldness; Bald; Baldness

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change in Additional Investigator Global Assessment of Photography

  Week 0, end of trial (8-16 weeks)

• Change in Scalp Symptom Assessments

  Week 0, Week 4(+4), Week 8(+4)

Study Arms (4)

Safety Group

EXPERIMENTAL

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; Drug: Post-laser 5mg minoxidil; Drug: Post-laser 10mg minoxidil; Drug: Post-laser 20mg minoxidil

Placebo

PLACEBO COMPARATOR

Laser: Fractional ablative, deep mode, 5% fractional coverage Post-Laser Saline 0.9%: 2ml of sterile saline solution applied post-laser procedure

Device: Laser

Treatment A

EXPERIMENTAL

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%

Treatment B

EXPERIMENTAL

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%; Drug: At-Home Minoxidil 5%

Interventions

Post-Laser Minoxidil 2% DRUG

2ml of 20mg/ml sterile solution, applied post-laser procedure

Also known as: Rogaine

Treatment A; Treatment B

At-Home Minoxidil 5% DRUG

2ml of 50mg/ml foam q24 h for duration of study

Also known as: Rogaine

Treatment B

Laser DEVICE

Fractional ablative, deep mode, 5% fractional coverage

Placebo; Safety Group

Post-laser 5mg minoxidil DRUG

0.25ml of 20mg/ml sterile solution, applied post-laser procedure

Also known as: Rogaine

Safety Group

Post-laser 10mg minoxidil DRUG

0.5ml of 20mg/ml sterile solution, applied post-laser procedure

Also known as: Rogaine

Safety Group

Post-laser 20mg minoxidil DRUG

1ml of 20mg/ml sterile solution, applied post-laser procedure

Also known as: Rogaine

Safety Group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males ages 21-65 years old with MPHL
• Norwood III vertex-V. The vertex scalp must be involved
• MPHL diagnosed by a board-certified dermatologist
• Willing to abstain from use of over the counter products and prescription products other than those supplied in the study
• Willing to abstain from the use of non-steroidal anti-inflammatory medications, aspirin, St. Johns Wart, and high doses of Vitamin E supplementation
• Subjects must be capable of giving informed consent
• Willing to adhere to protocol, including scalp examinations and photography

You may not qualify if:

• Allergy or intolerance to minoxidil
• Underlying disease that might be adversely affected by minoxidil.
• Immunosuppressed patients (history of transplantation, cancer, chemotherapy, splenectomy, HIV)
• Application of topical immunomodulatory or immunosuppressive agent in the preceding 6 weeks
• 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
• Clinical evidence of secondary skin infection (e.g. folliculitis)
• Other inflammatory or infectious skin disease that might interfere with evaluations during the study
• Investigational medications within the past 30 days
• Severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies
• Oral retinoids within the past 6 months and topical retinoid usage within the past 4 weeks
• Patients with history of or susceptible to keloid formation
• Finasteride or dutasteride within the past 6 weeks
• Spironolactone within the past 6 weeks
• Active infection
• Lesions in the treated area suspicious for malignancy

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil; Lasers

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 25, 2019
• Study Start: September 30, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)