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| ID | Type | Description | Link |
|---|---|---|---|
| TAZ11-2003 | Other Identifier | Allergan |
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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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The purpose of this study is to determine whether topical tazarotene (Tazorac), a receptor-selective synthetic retinoid that normalizes epidermal differentiation, ameliorates signs and symptoms of brittle nails.
"Brittle nails," referring to nails that chip, peel, or split excessively, occur in up to 30% of women and 15% of men, with highest prevalence among the elderly. Treatment of brittle nails involves restoration and maintenance of a normal degree of nail plate hydration by minimizing exposure to dehydrating chemicals and by use of moisturizers, such as alpha-hydroxy acids. Retinoids are vitamin A analogs that play a role in skin cell differentiation and proliferation. Tazarotene is a topical receptor-selective synthetic retinoid that normalizes epidermal differentiation and reduces the influx of inflammatory cells into the skin. In this single-center, open-label trial, subjects applied tazarotene to the nails twice daily for 24 weeks. Signs and symptoms were rated by the investigators and subjects during treatment and 12 weeks after discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Uncontrolled, Open-Label Pilot Study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tazorac | Drug | All patients were to apply topical tazarotene (Tazorac) twice daily to all affected fingernails for 24 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint was the change in the Physician's Global Improvement Assessment (PGIA) of the 2 target nails. The PGIA score reflects the comparison of photographs taken at baseline to the nails at 12 weeks, 24 weeks, and 36 weeks. | Weeks 12, 24, and 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Assessment (PGA) measures the severity of brittle nail symptoms. | Baseline, Week 12, and Week 24 | |
| Physician ratings of the roughness, raggedness, and peeling of the target nails. | All study visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Scher, MD | University of North Carolina | Principal Investigator |
| Julian Mackay-Wiggan, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| C562907 | Twenty-Nail Dystrophy |
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| ID | Term |
|---|---|
| C086827 | tazarotene |
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| A VapoMeter measures the Transonychial Water Loss (TOWL) on both target nails. | All study visits |
| Subject reporting provides the subjects' assessments of their nail breakage. | All study visits |
| Subject reporting provides the subjects' satisfaction with the product. | Week 12, 24, and 36 |