Androgenetic Alopecia
Conditions
Keywords
Female Pattern Baldness
Brief summary
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.
Detailed description
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.
Interventions
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
DRUGVehicle Topical Foam
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
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Area Hair Count | Baseline to Week 24 | Number of hairs in the area being examined as measured by macrophotography. |
| Subject Assessment of Scalp Coverage | Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Area Hair Count | Baseline to Week 12 | Number of hairs in the area being examined as measured by macrophotography. |
Countries
France, Germany, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Foam Vehicle Topical Foam
Vehicle Topical Foam: 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 | 201 |
| Minoxidil Foam 5% Minoxidil Topical Foam
5% Minoxidil Topical Foam: 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 | 203 |
| Total | 404 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 8 |
| Overall Study | Lost to Follow-up | 4 | 8 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Protocol Violation | 4 | 3 |
| Overall Study | Withdrawal by Subject | 10 | 13 |
Baseline characteristics
| Characteristic | Vehicle Foam | Minoxidil Foam | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 53 Participants | 46 Participants | 99 Participants |
| Age, Categorical Between 18 and 65 years | 148 Participants | 157 Participants | 305 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 participants | 1 participants | 4 participants |
| Race (NIH/OMB) Asian | 3 participants | 4 participants | 7 participants |
| Race (NIH/OMB) Black or African American | 55 participants | 50 participants | 105 participants |
| Race (NIH/OMB) More than one race | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 participants | 1 participants | 1 participants |
| Race (NIH/OMB) White | 140 participants | 145 participants | 285 participants |
| Sex: Female, Male Female | 201 Participants | 203 Participants | 404 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 57 / 201 | 63 / 203 |
| serious Total, serious adverse events | 4 / 201 | 6 / 203 |
Outcome results
Primary
Subject Assessment of Scalp Coverage
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.
Time frame: Week 24
Population: Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Eighteen participants in vehicle foam group and 23 participants in minoxidil foam group had no scalp coverage information.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Foam | Subject Assessment of Scalp Coverage | 0.06 scores on a scale | Standard Deviation 1.66 |
| Minoxidil Foam | Subject Assessment of Scalp Coverage | 0.74 scores on a scale | Standard Deviation 1.71 |
p-value: <0.000195% CI: [0.35, 1.04]ANCOVA
Primary
Target Area Hair Count
Number of hairs in the area being examined as measured by macrophotography.
Time frame: Baseline to Week 24
Population: Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in vehicle group and 3 participants in minoxidil foam group had no hair information at Baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Foam | Target Area Hair Count | Baseline | 152.7 hairs per centimeter squared | Standard Deviation 59.7 |
| Vehicle Foam | Target Area Hair Count | Week 24 | 162.2 hairs per centimeter squared | Standard Deviation 63.1 |
| Vehicle Foam | Target Area Hair Count | Change from Baseline to Week 24 | 4.0 hairs per centimeter squared | Standard Deviation 16.2 |
| Minoxidil Foam | Target Area Hair Count | Baseline | 158.6 hairs per centimeter squared | Standard Deviation 61.6 |
| Minoxidil Foam | Target Area Hair Count | Week 24 | 175.7 hairs per centimeter squared | Standard Deviation 65.1 |
| Minoxidil Foam | Target Area Hair Count | Change from Baseline to Week 24 | 13.5 hairs per centimeter squared | Standard Deviation 22.3 |
Comparison: Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in vehicle group and 3 participants in foam group had no hair information at Baseline. Statistical analysis is of the change from baseline to week 24 data.p-value: <0.000195% CI: [5, 13.1]ANCOVA
Secondary
Target Area Hair Count
Number of hairs in the area being examined as measured by macrophotography.
Time frame: Baseline to Week 12
Population: Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in the vehicle foam group and 3 participants in the minoxidil foam group had no hair count information at Baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Foam | Target Area Hair Count | Baseline | 152.7 hairs per centimeter squared | Standard Error 59.7 |
| Vehicle Foam | Target Area Hair Count | Week 12 | 163.3 hairs per centimeter squared | Standard Error 63.2 |
| Vehicle Foam | Target Area Hair Count | Change from Baseline to Week 12 | 5.4 hairs per centimeter squared | Standard Error 15.3 |
| Minoxidil Foam | Target Area Hair Count | Baseline | 158.6 hairs per centimeter squared | Standard Error 61.6 |
| Minoxidil Foam | Target Area Hair Count | Week 12 | 178.1 hairs per centimeter squared | Standard Error 66.4 |
| Minoxidil Foam | Target Area Hair Count | Change from Baseline to Week 12 | 16.4 hairs per centimeter squared | Standard Error 21.5 |
Comparison: Statistical analysis is of the change from baseline to week 12 data.p-value: <0.000195% CI: [7, 14.7]ANCOVA