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| ID | Type | Description | Link |
|---|---|---|---|
| CED2009 | Other Identifier | Allergan |
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This is an observational study of patients treated with bimatoprost 0.03% (Latisse®) for at least 12 months for hypotrichosis of the eyelashes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypotrichosis of the Eyelashes | Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost 0.03% | Drug | Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Satisfied With Latisse® | Overall subject satisfaction with Latisse® was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Applications of Latisse® Per Week | Number of applications of Latisse® per week as reported by the subjects. | Day 1 |
| Percentage of Subjects Satisfied Wtih Their Eyelashes | Overall subject satisfaction with their eyelashes was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with hypotrichosis of the eyelashes
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Ana | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25229783 | Background | Yoelin SG, Fagien S, Cox SE, Davis PG, Campo A, Caulkins CA, Gallagher CJ. A retrospective review and observational study of outcomes and safety of bimatoprost ophthalmic solution 0.03% for treating eyelash hypotrichosis. Dermatol Surg. 2014 Oct;40(10):1118-24. doi: 10.1097/01.DSS.0000452658.83001.d9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypotrichosis of the Eyelashes | Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypotrichosis of the Eyelashes | Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Subjects Satisfied With Latisse® | Overall subject satisfaction with Latisse® was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported. | Subjects with all study data | Posted | Number | Percentage of Subjects | 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 | Hypotrichosis of the Eyelashes | Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | 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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|
| Day 1 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Applications of Latisse® Per Week | Number of applications of Latisse® per week as reported by the subjects. | Subjects with all study data | Posted | Mean | Standard Deviation | Number of Applications | Day 1 |
|
|
|
| Secondary | Percentage of Subjects Satisfied Wtih Their Eyelashes | Overall subject satisfaction with their eyelashes was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported. | Subjects with all study data | Posted | Number | Percentage of Subjects | Day 1 |
|
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|
| 0 |
| 585 |
| 155 |
| 585 |
| Erythema of the Eyelid | Eye disorders | Non-systematic Assessment |
|
| Eye Pruritus | Eye disorders | Non-systematic Assessment |
|
| Ocular Irritation | Eye disorders | 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.
| D011465 |
| Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |