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Sponsors and Collaborators: |
Biomedical Development Corporation National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | Biomedical Development Corporation |
ClinicalTrials.gov Identifier: | NCT00614289 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Phase 1 Study to Demonstrate Efficacy of Epikeia Coatings in a Human Clinical Trial |
Estimated Enrollment: | 30 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | June 2008 (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.
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:
Contact: Adelaide A. Hebert, MD | 713-500-8266 | Adelaide.A.Hebert@uth.tmc.edu |
United States, Texas | |
UTHSC Houston, Dermatology Clincial Research Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Maria D. Lopez 713-500-8266 Maria.D.Lopez@uth.tmc.edu | |
Principal Investigator: Adelaide A. Hebert, MD |
Principal Investigator: | Adelaide A. Hebert, MD | University of Texas Health Science Center, Department of Dermatoloy |
Responsible Party: | University of Texas Health Science Center-Houston, Dermatology Clincial Research Center ( Adelaide A. Hebert, MD ) |
Study ID Numbers: | HSC-MS-06-0347, NIH Grant 1R43AR525441-1A1 |
Study First Received: | January 31, 2008 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00614289 |
Health Authority: | United States: Institutional Review Board |
Mild to Moderate Hand Dermatitis Hand Eczema |
Skin Diseases Skin Diseases, Eczematous Eczema Dermatitis, Contact Dermatitis |