Clinical Trial in Females for Female Pattern Hair Loss

A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam vs. Vehicle in Females for the Treatment of Female Pattern Hair Loss (Androgenetic Alopecia)

This is a six month clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.

This is a phase 3, two-arm, randomized, double-blind, vehicle-controlled, multi-center, 24-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the 5% MTF formulation versus the foam vehicle formulation. This clinical trial is designed to compare the risk/benefit profile of the new 5% MTF formulation applied once a day (OD) versus the foam vehicle formulation applied once a day (OD), using objective efficacy measures and safety assessments. Study centers will screen a sufficient number of participants so that a minimum of 300 female participants with FPHL will be enrolled, to ensure 260 complete. There will be at least 16 participants enrolled per center at multiple centers located across the US and globally. Approximately 300 participants will be randomly assigned in a 1:1 ratio to use either 5% MTF OD or foam vehicle OD, for 24 weeks for efficacy and safety evaluations. Participants meeting the inclusion criteria will be randomly assigned in the order of their enrollment at each site. The signing of the informed consent and assignment of a participant number to a subject shall constitute enrollment. During the trial following enrollment at Baseline, participants will return to the study site at Weeks 1, 6, 12, 18 and 24 for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12 and 24 visits, efficacy assessments will also be conducted, using Target Area Hair Counts (TAHC), measured by macrophotography.

Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks

Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks

Subject assessment of scalp coverage at Week 24 was measured as change from Baseline on a 7-point scale where 0 meant no perceived change in scalp coverage, +1 to +3 indicated progressively increased levels of scalp coverage, and -1 to -3 indicated progressively decreased levels.

Inclusion Criteria: females, age 18 or older in general good health exhibits female pattern hair loss signs and dates an informed consent document agrees to use an adequate method of birth control; if of childbearing potential shows a negative urine pregnancy test at Screening Visit is willing to maintain the same hair style, hair color, and hair regimen throughout the study is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures Exclusion Criteria: hypersensitivity to the (study product), or any ingredients of the (study product) known allergy to hair dye, or hair dye components clinically relevant history of hypotension untreated or uncontrolled hypertension pregnant, planning a pregnancy or nursing a child history of hair transplants currently use hair weaves or non-breathable wigs dermatologic disorders of the scalp that require chronic use of medication for control other types or history of hair loss enrolled in any other investigational medication (drug) study currently, or within the last 6 months