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| ID | Type | Description | Link |
|---|---|---|---|
| NIH Grant 1R43AR525441-1A1 |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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This study is designed as a prospective, randomized, double-blind right/left comparison of Epikeia coatings to improve hand dermatitis.
Hand dermatitis was chosen for investigation due to high incidence and typical symmetrical involvement that allows for right/left treatment comparisons. Hand dermatitis is also important due to its implication on healthcare workers in particular, where frequent hand washing and chronic occlusion from gloving, provide a route for skin sensitization to natural rubber latex proteins increase the risk of colonization of microorganisms on the skin, and thereby increase the likelihood of contact dermatitis.
This feasibility study will be performed to evaluate the efficacy of PVDF coatings in treating chronic hand dermatitis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epikeia Coatings | Device | Topical skin coating |
| Measure | Description | Time Frame |
|---|---|---|
| The endpoints for evaluation will be the within subject (test vs. control hands) comparison on Investigator Global Assessment, and Hand Eczema Area and Severity Scores. | 85 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal scales measuring subjective efficacy, pain and itching. | 85 Days |
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Inclusion Criteria:
Subjects must meet the following inclusion criteria:
Exclusion Criteria:
Subjects will be excluded from the study if they:
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| Name | Affiliation | Role |
|---|---|---|
| Adelaide A. Hebert, MD | University of Texas Health Science Center, Department of Dermatoloy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTHSC Houston, Dermatology Clincial Research Center | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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