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This study will evaluate the skin pharmacokinetics and tolerability of bimatoprost Formulation A and Formulation B following 14 days of once daily topical administration in male participants with androgenetic alopecia (AGA).
Single-center, multiple-dose study evaluting the local pharmacokinetics and tolerability of bimatoprost following 14 days of once daily topical administration of bimatoprost Formulation A and Formulation B (both containing 1% bimatoprost) to the scalp of male patients With androgenetic alopecia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Experimental | Bimatoprost 1% Formulation A solution applied to the left side of the scalp and trunk area and Bimatoprost 1% Formulation B solution applied to the right side of the scalp and trunk area once daily for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost 1% Formulation A | Drug | Bimatoprost 1% Formulation A solution applied to the scalp and trunk once daily for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drug Concentration in Skin Biopsy Samples | Day 14 | |
| Percentage of Participants with at Least 1 Treatment Emergent Adverse Event | 28 Days |
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Inclusion Criteria:
-Patients with mild to moderate Androgenetic Alopecia of the vertex area of the scalp.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle McGeeney | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DermResearch, LLC | Austin | Texas | 78759 | United States |
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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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| Bimatoprost 1% Formulation B | Drug | Bimatoprost 1% Formulation B solution applied to the scalp and trunk once daily for 14 days. |
|
| 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 |