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Study to Evaluate the safety and efficacy of a Latanoprost/Minoxidil formulation vs. placebo for the treatment of hypotrichosis of the eyebrows.
A Single-Blind placebo controlled trial of the efficacy and safety of the treatment of hypotrichosis of the eyebrows comparing a subset of patients receiving a combination of latanoprost/minoxidil formulation as compared to placebo measured by a validated imaging system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Latanoprost/Minoxidil formulation | Experimental | 8 participants: Topical Latanoprost/Minoxidil formulation applied to both eyebrows once a day for 90 days |
|
| Control Group | Placebo Comparator | 4 participants: Vehicle applied to both eyebrows once a day for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latanoprost and Minoxidil | Combination Product | Latanoprost and Minoxidil formulation for the treatment of hypotrichosis of the eyebrows. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Area Hair Count | Target Area Hair Count as Determined by the Brigham Tool for Alopecia | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized Global Photographs | 1. Standardized Global Photographs and change from baseline measurement of eyebrow hair fullness using Canfield Eyebrow Hair Image Analysis. | 90 days |
| Change in Total Area Hair Darkness |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Self Assessment | 1. Subject Self-Assessment and Investigator Global Assessment using a Canfield side-by-side comparison tool on Day 90. Measure participant's satisfaction with eyebrow treatment. | 90 Days |
Inclusion Criteria: • Subjects, age 22 to 65 years, in general good health.
Exclusion Criteria: • Subjects with an active disease or infection, or chronic dermatological condition (eczema, psoriasis, infection, etc.) of the scalp that may interfere with the assessment of scalp skin health in the treated regions.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dan Cosgrove, M.D. | Contact | 760-777-7698 | heidi@wellmax.com |
| Name | Affiliation | Role |
|---|---|---|
| Dan Cosgrove, M.D. | WellMax | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WellMax | Recruiting | Indian Wells | California | 92210 | United States |
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| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| ID | Term |
|---|---|
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| D008914 | Minoxidil |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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Unlabeled bottle.
2. Change in Total Area Hair Darkness of non-vellus hairs as compared to baseline in target area, defined as change from baseline of non-vellus hairs measured in intensity units as determined by Canfield Eyebrow Hair Image Analysis.
| 90 days |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |