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This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Part 2 will begin after Part 1 has completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: bimatoprost Formulation A | Experimental | bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. |
|
| Part 1: bimatoprost Formulation B | Experimental | bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. |
|
| Part 2: bimatoprost Formulation C | Experimental | bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost Formulation A | Drug | bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost | Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended. | Day 1 |
| Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost | Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended. | 17 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings | An ECG is a tracing of the heart's electrical activity over time in waves with points identified at P, Q, R, S, and T [measured in milliseconds (ms)], as well as the heart rate [measured in beats per minute (bpm)]. Clinically significant abnormal results include maximum post-treatment QTcB>500 ms, maximum post-treatment QTcF>500 ms, maximum post-treatment QT interval >500 ms, PR interval 25% increase from baseline and >200 ms, QRS interval 25% increase from baseline and >100 ms, heart rate 25% increase from baseline and >100 bpm, and heart rate 25% decrease from baseline and <50 bpm. |
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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 |
|---|---|---|---|---|---|---|
| Tempe | Arizona | United States |
Part 1 of the study was double-blind, followed by Part 2 which was open-label. No patients enrolled in Part 1 were enrolled in Part 2 of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Bimatoprost Formulation A | bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. |
| FG001 | Part 1: Bimatoprost Formulation B | bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. |
| FG002 | Part 2: Bimatoprost Formulation C | bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Bimatoprost Formulation A | bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. |
| BG001 | Part 1: Bimatoprost Formulation B | bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost | Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended. | Per Protocol: all subjects with no major protocol deviations | Posted | Mean | Standard Deviation | Picograms/Milliliter (pg/mL) | Day 1 |
|
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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 | Part 1: Bimatoprost Formulation A | bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| bimatoprost Formulation B | Drug | bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. |
|
| bimatoprost Formulation C | Drug | bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17. |
|
| 17 Days |
| Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Local scalp tolerability by patient assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 3 symptoms (burning, itching, and stinging). An at least 1-grade increase from baseline at any timepoint indicates a worsening of symptoms. | Baseline, 20 Days |
| Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Local scalp tolerability by dermatologist assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 5 symptoms (dryness/scaling, edema, erythema, folliculitis, and pigmentation). An at least 1-grade increase at any timepoint from baseline indicates a worsening of symptoms. | Baseline, 20 Days |
| BG002 | Part 2: Bimatoprost Formulation C | bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Part 2: Bimatoprost Formulation C | bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17. |
|
|
| Primary | Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost | Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended. | Per Protocol: all subjects with no major protocol deviations | Posted | Mean | Standard Deviation | Picograms/Milliliter (pg/mL) | 17 Days |
|
|
|
| Secondary | Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings | An ECG is a tracing of the heart's electrical activity over time in waves with points identified at P, Q, R, S, and T [measured in milliseconds (ms)], as well as the heart rate [measured in beats per minute (bpm)]. Clinically significant abnormal results include maximum post-treatment QTcB>500 ms, maximum post-treatment QTcF>500 ms, maximum post-treatment QT interval >500 ms, PR interval 25% increase from baseline and >200 ms, QRS interval 25% increase from baseline and >100 ms, heart rate 25% increase from baseline and >100 bpm, and heart rate 25% decrease from baseline and <50 bpm. | Safety Population: all subjects who received at least 1 dose of study medication | Posted | Number | Percentage of Patients | 17 Days |
|
|
|
| Secondary | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Local scalp tolerability by patient assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 3 symptoms (burning, itching, and stinging). An at least 1-grade increase from baseline at any timepoint indicates a worsening of symptoms. | Safety Population: all subjects who received at least 1 dose of study medication | Posted | Number | Patients | Baseline, 20 Days |
|
|
|
| Secondary | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Local scalp tolerability by dermatologist assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 5 symptoms (dryness/scaling, edema, erythema, folliculitis, and pigmentation). An at least 1-grade increase at any timepoint from baseline indicates a worsening of symptoms. | Safety Population: all subjects who received at least 1 dose of study medication | Posted | Number | Patients | Baseline, 20 Days |
|
|
|
| 0 |
| 14 |
| 7 |
| 14 |
| EG001 | Part 1: Bimatoprost Formulation B | bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. | 0 | 14 | 6 | 14 |
| EG002 | Part 2: Bimatoprost Formulation C | bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17. | 0 | 14 | 1 | 14 |
| Feeling Hot | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Application Site Folliculitis | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Procedural Hypotension | Injury, poisoning and procedural complications | MedDRA version 13.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
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.
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Stinging |
|
| Title | Measurements |
|---|---|
|
| Erythema |
|
| Folliculitis |
|
| Pigmentation |
|