Alopecia
Conditions
Keywords
Female Pattern Baldness
Brief summary
This is a year-long clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day. This clinical trial uses an objective measurement called Target Area Hair Count (TAHC) to evaluate if there is a change in the number of hairs in the area being examined after using the product for 24 weeks (and also after using the product for 12 Weeks and for 52 weeks). This trial will determine if the benefit of using either study product outweighs the risks.
Detailed description
This is a phase 3, two-arm, randomized, active-controlled, multi-center, 52-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the new 5% minoxidil topical foam (MTF) formulation versus the 2% minoxidil topical solution (MTS) formulation. This clinical trial is designed to compare the risk/benefit profile of the 5% MTF formulation applied once a day versus the 2% MTS applied twice a day (BID), 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 270 to 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 or 2% MTS, for 52 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 regular intervals for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12, 24, and Week 52 visits TAHC will be evaluated for efficacy analysis.
Interventions
DRUG5% Minoxidil
half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks
DRUG2% Minoxidil
one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks
Sponsors
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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 (TAHC) | Baseline to Week 24 | Number of hairs in the area being examined as measured by macrophotography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Area Hair Count (TAHC) | Baseline to Week 12 | Number of hairs in the area being examined as measured by macrophotography |
Other
| Measure | Time frame | Description |
|---|---|---|
| Target Area Hair Count (TAHC) | Baseline to Week 52 | Number of hairs in the area being examined as measured by macrophotography. |
Countries
Canada, France, Germany, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2% MTS 2% Minoxidil Topical Solution
2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks | 161 |
| 5% MTF 5% Minoxidil Topical Foam
5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks | 161 |
| Total | 322 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 4 |
| Overall Study | Lost to Follow-up | 8 | 9 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Protocol Violation | 3 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 16 |
Baseline characteristics
| Characteristic | 2% MTS | 5% MTF | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 26 Participants | 31 Participants | 57 Participants |
| Age, Categorical Between 18 and 65 years | 134 Participants | 129 Participants | 263 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 9 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 | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) White | 149 Participants | 141 Participants | 290 Participants |
| Sex: Female, Male Female | 161 Participants | 161 Participants | 322 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 | 118 / 161 | 109 / 161 |
| serious Total, serious adverse events | 8 / 161 | 2 / 161 |
Outcome results
Primary
Target Area Hair Count (TAHC)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% MTS | Target Area Hair Count (TAHC) | Baseline | 167.3 hairs per centimeter squared | Standard Deviation 55 |
| 2% MTS | Target Area Hair Count (TAHC) | Week 24 | 192.8 hairs per centimeter squared | Standard Deviation 57 |
| 2% MTS | Target Area Hair Count (TAHC) | Change from Baseline to Week 24 | 23.8 hairs per centimeter squared | Standard Deviation 24.7 |
| 5% MTF | Target Area Hair Count (TAHC) | Baseline | 169.7 hairs per centimeter squared | Standard Deviation 58.6 |
| 5% MTF | Target Area Hair Count (TAHC) | Week 24 | 194.4 hairs per centimeter squared | Standard Deviation 64.7 |
| 5% MTF | Target Area Hair Count (TAHC) | Change from Baseline to Week 24 | 23.7 hairs per centimeter squared | Standard Deviation 22.9 |
Comparison: Statistical analysis is for the change from baseline to week 24 data.p-value: 0.91795% CI: [-6, 5.4]ANCOVA
Secondary
Target Area Hair Count (TAHC)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% MTS | Target Area Hair Count (TAHC) | Baseline | 167.3 hairs per centimeter squared | Standard Deviation 55 |
| 2% MTS | Target Area Hair Count (TAHC) | Week 12 | 190.7 hairs per centimeter squared | Standard Deviation 56.9 |
| 2% MTS | Target Area Hair Count (TAHC) | Change from Baseline to Week 12 | 22.5 hairs per centimeter squared | Standard Deviation 22.8 |
| 5% MTF | Target Area Hair Count (TAHC) | Baseline | 169.7 hairs per centimeter squared | Standard Deviation 58.6 |
| 5% MTF | Target Area Hair Count (TAHC) | Week 12 | 191.8 hairs per centimeter squared | Standard Deviation 62.6 |
| 5% MTF | Target Area Hair Count (TAHC) | Change from Baseline to Week 12 | 24.9 hairs per centimeter squared | Standard Deviation 26 |
Comparison: Statistical analysis is for the change from baseline to week 12 data.p-value: <0.415895% CI: [-3.4, 8.2]ANCOVA
Other Pre-specified
Target Area Hair Count (TAHC)
Number of hairs in the area being examined as measured by macrophotography.
Time frame: Baseline to Week 52
Population: Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% MTS | Target Area Hair Count (TAHC) | Baseline | 167.3 hairs per centimeter squared | Standard Deviation 55 |
| 2% MTS | Target Area Hair Count (TAHC) | Week 52 | 189.1 hairs per centimeter squared | Standard Deviation 55.8 |
| 2% MTS | Target Area Hair Count (TAHC) | Change from Baseline to Week 52 | 19.4 hairs per centimeter squared | Standard Deviation 21.5 |
| 5% MTF | Target Area Hair Count (TAHC) | Baseline | 169.7 hairs per centimeter squared | Standard Deviation 58.6 |
| 5% MTF | Target Area Hair Count (TAHC) | Week 52 | 186.9 hairs per centimeter squared | Standard Deviation 61.1 |
| 5% MTF | Target Area Hair Count (TAHC) | Change from Baseline to Week 52 | 18.1 hairs per centimeter squared | Standard Deviation 23.4 |
Comparison: Statistical analysis is for the change from baseline to week 52 data.p-value: 0.59895% CI: [-7.1, 4.1]ANCOVA