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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000379-15 | EudraCT Number |
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This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bimatoprost Formulation A | Experimental | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
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| bimatoprost Formulation B | Experimental | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
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| bimatoprost Formulation C | Experimental | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
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| bimatoprost vehicle solution | Placebo Comparator | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
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| minoxidil 5% solution | Active Comparator | Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost Formulation A | Drug | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Target Area Hair Count (TAHC) | TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs). | Baseline, Month 6 |
| Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented. | Baseline, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portland | Oregon | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost Formulation A | Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| FG001 | Bimatoprost Formulation B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| bimatoprost Formulation B | Drug | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
|
| bimatoprost Formulation C | Drug | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
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| bimatoprost vehicle solution | Drug | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
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| minoxidil 5% solution | Drug | Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months. |
|
|
| Baseline, Month 6 |
| Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented. | Baseline, Month 6 |
| Change From Baseline in Target Area Hair Width (TAHW) | Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs). | Baseline, Month 6 |
| Change From Baseline in Target Area Hair Darkness (TAHD) | Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs). | Baseline, Month 6 |
| Berlin |
| Germany |
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
| FG002 | Bimatoprost Formulation C | Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| FG003 | Vehicle to Bimatoprost | Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| FG004 | Minoxidil 5% Solution | Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost Formulation A | Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| BG001 | Bimatoprost Formulation B | Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| BG002 | Bimatoprost Formulation C | Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| BG003 | Vehicle to Bimatoprost | Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| BG004 | Minoxidil 5% Solution | Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months. |
| BG005 | 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, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Target Area Hair Count (TAHC) | TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs). | Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure. | Posted | Mean | Standard Deviation | terminal hairs/cm^2 | Baseline, Month 6 |
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| Primary | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented. | Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure. | Posted | Number | Percentage of participants | Baseline, Month 6 |
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| Secondary | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented. | Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure. | Posted | Number | Percentage of participants | Baseline, Month 6 |
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| Secondary | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented. | Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure. | Posted | Number | Percentage of participants | Baseline, Month 6 |
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| Secondary | Change From Baseline in Target Area Hair Width (TAHW) | Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs). | Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure. | Posted | Mean | Standard Deviation | mm/cm^2 | Baseline, Month 6 |
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| Secondary | Change From Baseline in Target Area Hair Darkness (TAHD) | Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs). | Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure. | Posted | Mean | Standard Deviation | Intensity units | Baseline, Month 6 |
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The Safety Population, that consisted of all participants who received at least 1 dose of study treatment, was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
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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 | Bimatoprost Formulation A | Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months. | 0 | 61 | 6 | 61 | ||
| EG001 | Bimatoprost Formulation B | Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months. | 1 | 61 | 11 | 61 | ||
| EG002 | Bimatoprost Formulation C | Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months. | 1 | 62 | 4 | 62 | ||
| EG003 | Vehicle to Bimatoprost | Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months. | 1 | 62 | 7 | 62 | ||
| EG004 | Minoxidil 5% Solution | Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months. | 0 | 61 | 10 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment | Event not treatment-related |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment | Event not treatment-related |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment | Event not treatment-related |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment | Event not treatment-related |
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| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment | Event not treatment-related |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment | Event not treatment-related |
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| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment | Event not treatment-related |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Application site pruritis | General disorders | MedDRA (15.0) | Non-systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| 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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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D004364 | Pharmaceutical Preparations |
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| 35 to 50 years |
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| Male |
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| Change from Baseline at Month 6 |
|
| OG003 | Vehicle to Bimatoprost | Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| OG004 | Minoxidil 5% Solution | Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months. |
|
|
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
| OG003 | Vehicle to Bimatoprost | Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| OG004 | Minoxidil 5% Solution | Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months. |
|
|
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
| OG003 | Vehicle to Bimatoprost | Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| OG004 | Minoxidil 5% Solution | Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months. |
|
|
| OG003 | Vehicle to Bimatoprost | Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| OG004 | Minoxidil 5% Solution | Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months. |
|
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| OG003 | Vehicle to Bimatoprost | Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| OG004 | Minoxidil 5% Solution | Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months. |
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