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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019881-96 | EudraCT Number |
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| Name | Class |
|---|---|
| Johnson & Johnson Consumer and Personal Products Worldwide | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minoxidil Foam | Experimental | 5% Minoxidil Topical Foam |
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| Vehicle Foam | Placebo Comparator | Vehicle Topical Foam |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% Minoxidil Topical Foam | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Target Area Hair Count | Number of hairs in the area being examined as measured by macrophotography. | Baseline to Week 24 |
| 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. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Target Area Hair Count | Number of hairs in the area being examined as measured by macrophotography. | Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clare Kendall | Johnson & Johnson Consumer and Personal Products Worldwide | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Axis Clinical Trials | Los Angeles | California | 90036 | United States | ||
| Axis Clinical Trials |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Minoxidil Foam |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Vehicle Topical Foam | Drug | 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 |
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| Los Angeles |
| California |
| 90057 |
| United States |
| Therapeutics Clinical Research | San Diego | California | 92123 | United States |
| Heartland Research Associates LLC | Wichita | Kansas | 67207 | United States |
| Callender Skin & Laser Center | Glenn Dale | Maryland | 20769 | United States |
| Michigan Center for Skin Care Research | Clinton Township | Michigan | 48038 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| Derm Research Center of New York | Stony Brook | New York | 11790 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| J&S Studies, Inc. | College Station | Texas | 77845 | United States |
| David A. Whiting, MD PA | Dallas | Texas | 75246 | United States |
| The Education & Research Foundation Inc | Lynchburg | Virginia | 24501 | United States |
| Hôpital Saint Jacques Service de Dermatologie | Besançon | 25030 | France |
| Clinical Research Center for Hair and Skin Science Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| Dermaticum Practice for Dermatology | Freiburg im Breisgau | 79098 | Germany |
| George Eliot Hospital | Nuneaton | CV10 7DJ | United Kingdom |
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
| COMPLETED |
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| NOT COMPLETED |
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Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | One participant in minoxidil foam group had no information on race and hair loss duration | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Target Area Hair Count | Number of hairs in the area being examined as measured by macrophotography. | 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. | Posted | Mean | Standard Deviation | hairs per centimeter squared | Baseline to Week 24 |
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| Secondary | Target Area Hair Count | Number of hairs in the area being examined as measured by macrophotography. | 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. | Posted | Mean | Standard Error | hairs per centimeter squared | Baseline to Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Week 24 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 4 | 201 | 57 | 201 | ||
| EG001 | 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 | 6 | 203 | 63 | 203 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Ovarian Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Uterine Leiomyoma | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Cardiovascular Disorder | Cardiac disorders | MedDRA 14.1 | Systematic Assessment | Death (1 participant died from cardiovascular disease) |
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| Cor Pulmonale Acute | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment | Death (1 participant died from both renal failure and dehydration). Note that this is the same participant that died from renal failure. |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Memory Impairment | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Mental Status Changes | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Post-Traumatic Stress Disorder | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment | Death (1 participant died from both renal failure and dehydration). Note that this is the same participant who died from dehydration. |
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| Hypertensive Crisis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Weight Increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
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Multi-Center Publication will be the first publication to present the results of the Study. Upon such Multi-Center Publication, or the earlier of (a) Sponsor's confirmation that there will be no Multi-Center Publication or presentation, or (b) 12 months after the completion of the entire multi-center study, Institution and Investigator may publish or present Study data and results generated in their performance of the Study in accordance with the terms of this Article.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Johnson & Johnson Healthcare Products Division of MCNEIL-PPC, Inc. | (973) 385-3203 |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Change from Baseline to Week 24 |
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| Participants |
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