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This study will evaluate the safety and efficacy of bimatoprost solution compared with vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimatoprost Solution BID | Experimental | Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months. |
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| Bimatoprost Solution QD | Experimental | Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months. |
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| Vehicle to Bimatoprost Solution BID | Placebo Comparator | Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost solution | Drug | Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale | The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported. | Baseline, Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA) | Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyebrows (improvement). | Baseline, Month 7 |
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Inclusion Criteria:
-Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston | Texas | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27124878 | Background | Carruthers J, Beer K, Carruthers A, Coleman WP 3rd, Draelos ZD, Jones D, Goldman MP, Pucci ML, VanDenburgh A, Weng E, Whitcup SM. Bimatoprost 0.03% for the Treatment of Eyebrow Hypotrichosis. Dermatol Surg. 2016 May;42(5):608-17. doi: 10.1097/DSS.0000000000000755. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost Solution BID | Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months. |
| FG001 | Bimatoprost Solution QD | Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months. |
| FG002 | Vehicle to Bimatoprost Solution BID | Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
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| Post-treatment Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost Solution BID | Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months. |
| BG001 | Bimatoprost Solution QD | Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months. |
| 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 |
| 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 (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale | The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported. | Intent-to-treat population included all randomized participants. | Posted | Number | percentage of participants | Baseline, Month 7 |
|
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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 BID | Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | 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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| Vehicle to bimatoprost solution | Drug | Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months. |
|
| Change From Baseline in Eyebrow Darkness as Measured Using DMSIA | Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement). | Baseline, Month 7 |
| Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6 | ESS Item #6 measured the participant's satisfaction with eyebrow treatment: "Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now?" using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported. | Month 7 |
| Vancouver |
| British Columbia |
| Canada |
| Personal Reasons |
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| Other Miscellaneous Reasons |
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| NOT COMPLETED |
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| BG002 | Vehicle to Bimatoprost Solution BID | Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
| OG002 | Vehicle to Bimatoprost Solution BID | Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months. |
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| Secondary | Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA) | Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyebrows (improvement). | Participants from the Intent-to-treat population, all randomized participants, with data available for analysis. | Posted | Mean | Standard Deviation | mm^2 | Baseline, Month 7 |
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| Secondary | Change From Baseline in Eyebrow Darkness as Measured Using DMSIA | Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement). | Participants from the Intent-to-treat population, all randomized participants, with data available for analysis. | Posted | Mean | Standard Deviation | intensity units | Baseline, Month 7 |
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| Secondary | Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6 | ESS Item #6 measured the participant's satisfaction with eyebrow treatment: "Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now?" using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported. | Intent-to-treat population included all randomized participants. | Posted | Number | percentage of participants | Month 7 |
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| 2 |
| 118 |
| 6 |
| 118 |
| EG001 | Bimatoprost Solution QD | Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months. | 0 | 118 | 5 | 118 |
| EG002 | Vehicle to Bimatoprost Solution BID | Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months. | 5 | 121 | 7 | 121 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 17.0 | 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.
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