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The purpose of this study is to determine the effect of bimatoprost solution on scalp hair growth. Bimatoprost 0.03% ophthalmic solution is currently approved by the FDA for treatment of glaucoma (Lumigan™) and for thickening of thin eyelashes (Latisse™). Bimatoprost 0.03% is not approved for the treatment of scalp hair loss and its use in this study is considered investigational which means it is still being tested in research studies.
Thirty-three subjects were consented and screened, 9 entered and 9 completed the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active drug | Active Comparator | During Part I of the study, subjects will be randomized in a blinded fashion to either placebo (vehicle that does not contain active drug) or topical bimatoprost to apply to the scalp target area every day for 16 weeks. After a 10 day washout period, each group will be crossed over to the alternate topical preparation (Part II) to apply for 16 weeks. |
|
| Placebo | Active Comparator | During Part I of the study, subjects will be randomized in a blinded fashion to either placebo (vehicle that does not contain active drug) or topical bimatoprost to apply to the scalp target area every day for 16 weeks. After a 10 day washout period, each group will be crossed over to the alternate topical preparation (Part II) to apply for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost | Drug | Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Target Area Total Hair Count | The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study. | Baseline to week 17; and week 17 to week 34 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in the Target Area Terminal Hair Count | Terminal hairs are those which grow beyond a cm and contribute to overall hair density. | Baseline to week 17; and week 17 to week 34 |
| Percent Change in the Target Area Vellus Hair Count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elise Olsen, MD | Duke University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Bimatoprost | Part 1: Patients initially were randomized to apply placebo topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks. |
| FG001 | Bimatoprost Then Placebo | Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were randomized to apply placebo topically for 16 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Then Bimatoprost | Part 1: Patients initially were randomized to apply placebo topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percent Change in Target Area Total Hair Count | The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study. | intention to treat (ITT) | Posted | Mean | Full Range | percentage change in total hair count | Baseline to week 17; and week 17 to week 34 |
|
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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 | Placebo Then Bimatoprost | Part 1: Patients initially were randomized to apply placebo topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elise Olsen | Duke University Medical Center | 919-668-5613 | elise.olsen@dm.duke.edu |
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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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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
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| Placebo | Drug |
|
Vellus hairs are fine hairs that generally do not grow beyond 1 cm and do not contribute to overall hair density. For the most part, they have a diameter of <40 um. They are increased in number in male pattern baldness
| Baseline to week 17; and week 17 to week 34 |
| Percent Change in Hair Diameter | The percent change in hair diameter is a recent addition to the methods of assessing efficacy of hair growth promoters. It is a measure of hair mass and does not separate out the effect on terminal and vellus hairs but rather combines the effect on both. Since it is only terminal hairs that contributes to normal hair density, this measure does not add anything to the measures of total, terminal and vellus hair counts in terms of overall effect on hair growth and is therefore not analyzed or reported here. | Baseline to week 17; Week 17 to week 34 |
| Bimatoprost Then Placebo |
Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were randomized to apply placebo topically for 16 weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were randomized to apply placebo topically for 16 weeks.
|
|
| Secondary | Percent Change in the Target Area Terminal Hair Count | Terminal hairs are those which grow beyond a cm and contribute to overall hair density. | Posted | Mean | Full Range | percent change of terminal hair count | Baseline to week 17; and week 17 to week 34 |
|
|
|
| Secondary | Percent Change in the Target Area Vellus Hair Count | Vellus hairs are fine hairs that generally do not grow beyond 1 cm and do not contribute to overall hair density. For the most part, they have a diameter of <40 um. They are increased in number in male pattern baldness | Posted | Mean | Full Range | Percent change of vellus hair count | Baseline to week 17; and week 17 to week 34 |
|
|
|
| Secondary | Percent Change in Hair Diameter | The percent change in hair diameter is a recent addition to the methods of assessing efficacy of hair growth promoters. It is a measure of hair mass and does not separate out the effect on terminal and vellus hairs but rather combines the effect on both. Since it is only terminal hairs that contributes to normal hair density, this measure does not add anything to the measures of total, terminal and vellus hair counts in terms of overall effect on hair growth and is therefore not analyzed or reported here. | Data not analyzed, and therefore not reported. | Posted | Baseline to week 17; Week 17 to week 34 |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Bimatoprost Then Placebo | Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were randomized to apply placebo topically for 16 weeks. | 0 | 6 | 0 | 9 |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011465 |
| Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |