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This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bimatoprost solution 0.03% | Experimental | One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. |
|
| bimatoprost vehicle solution | Placebo Comparator | One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost solution 0.03% | Drug | One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA) | The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement. | Baseline, Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA) | Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement). | Baseline, Month 4 |
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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 |
|---|---|---|---|---|---|---|
| Chiba | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24643895 | Background | Harii K, Arase S, Tsuboi R, Weng E, Daniels S, VanDenburgh A. Bimatoprost for eyelash growth in Japanese subjects: two multicenter controlled studies. Aesthetic Plast Surg. 2014 Apr;38(2):451-60. doi: 10.1007/s00266-014-0293-7. Epub 2014 Mar 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost Solution 0.03% | One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. |
| FG001 | Bimatoprost Vehicle Solution | One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost Solution 0.03% | One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. |
| BG001 | Bimatoprost Vehicle Solution |
| 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 | Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA) | The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement. | Intent to treat population included all randomized participants. | Posted | Number | Percentage of participants | Baseline, Month 4 |
|
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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 Solution 0.03% | One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | MedDRA 15.0 | 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 |
|---|---|
| D000069580 | Bimatoprost |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
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|
| bimatoprost vehicle solution | Drug | One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months. |
|
| Change From Baseline in Eyelash Thickness as Measured by DIA | Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement). | Baseline, Month 4 |
| Change From Baseline in Eyelash Darkness as Measured by DIA | Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement). | Baseline, Month 4 |
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months. |
|
|
| Secondary | Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA) | Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement). | Participants from the Intent to treat population with data available for analysis. | Posted | Median | Full Range | mm | Baseline, Month 4 |
|
|
|
| Secondary | Change From Baseline in Eyelash Thickness as Measured by DIA | Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement). | Participants from the Intent to treat population with data available for analysis. | Posted | Median | Full Range | mm^2 | Baseline, Month 4 |
|
|
|
| Secondary | Change From Baseline in Eyelash Darkness as Measured by DIA | Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement). | Participants from the Intent to treat population with data available for analysis. | Posted | Median | Full Range | Units on a scale | Baseline, Month 4 |
|
|
|
| 0 |
| 18 |
| 12 |
| 18 |
| EG001 | Bimatoprost Vehicle Solution | One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months. | 2 | 18 | 13 | 18 |
| Cellulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Erythema of eyelid | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Sensation of pressure | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Affective disorder | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Pruritus genital | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Milia | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Blood pressure fluctuation | Vascular disorders | MedDRA 15.0 | 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.
| D011465 |
| Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |