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This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (AGA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Bimatoprost 0.3% (Formulation B) | Experimental | 0.25 mL of bimatoprost 0.3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. |
|
| Cohort 2: Bimatoprost 1% (Formulation A) | Experimental | 0.25 mL of bimatoprost 1% (Formulation A) applied onto pre-specified area on the scalp once daily for 28 days. |
|
| Cohort 2: Bimatoprost 1% (Formulation B) | Experimental | 0.25 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. |
|
| Cohort 3: Bimatoprost 1% (Formulation B) | Experimental | 1 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. |
|
| Cohort 4: Bimatoprost 3% (Formulation B) | Experimental | 1 mL of bimatoprost 3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) | 42 Days | |
| Change from Baseline in Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale | Baseline, 42 Days | |
| Maximum plasma level (Cmax) of bimatoprost and its acid metabolite | 31 Days |
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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 |
|---|---|---|---|---|---|---|
| DermResearch, LLC | Austin | Texas | 78759 | United States | ||
| J&S Studies Inc. |
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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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|
| College Station |
| Texas |
| 77845 |
| United States |
| E&R Research Foundation | Lynchburg | Virginia | 24501 | United States |
| 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 |