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| Sponsor: | Biomedical Development Corporation |
|---|---|
| Collaborator: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| Information provided by: | Biomedical Development Corporation |
| ClinicalTrials.gov Identifier: | NCT00614289 |
Purpose
This study is designed as a prospective, randomized, double-blind right/left comparison of Epikeia coatings to improve hand dermatitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Contact Dermatitis Eczema, Contact |
Device: Epikeia Coatings |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 1 Study to Demonstrate Efficacy of Epikeia Coatings in a Human Clinical Trial |
| Enrollment: | 30 |
| Study Start Date: | August 2006 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must meet the following inclusion criteria:
Exclusion Criteria:
Subjects will be excluded from the study if they:
Contacts and Locations| United States, Texas | |
| UTHSC Houston, Dermatology Clincial Research Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Adelaide A. Hebert, MD | University of Texas Health Science Center, Department of Dermatoloy |
More Information
| Responsible Party: | Adelaide A. Hebert, MD, University of Texas Health Science Center-Houston, Dermatology Clincial Research Center |
| ClinicalTrials.gov Identifier: | NCT00614289 History of Changes |
| Other Study ID Numbers: | HSC-MS-06-0347, NIH Grant 1R43AR525441-1A1 |
| Study First Received: | January 31, 2008 |
| Last Updated: | March 4, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Mild to Moderate Hand Dermatitis Hand Eczema |
|
Dermatitis Dermatitis, Contact Eczema Skin Diseases Skin Diseases, Eczematous |