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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 31, 2008 | ||||
| Last Updated Date | June 10, 2009 | ||||
| Start Date ICMJE | August 2006 | ||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. [ Time Frame: 85 Days ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00614289 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Ordinal scales measuring subjective efficacy, pain and itching. [ Time Frame: 85 Days ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Novel Topical Treatment of Hand Dermatitis (Eczema) | ||||
| Official Title ICMJE | Phase 1 Study to Demonstrate Efficacy of Epikeia Coatings in a Human Clinical Trial | ||||
| Brief Summary | This study is designed as a prospective, randomized, double-blind right/left comparison of Epikeia coatings to improve hand dermatitis. |
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| Detailed Description | 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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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Device: Epikeia Coatings | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | November 2009 | ||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Subjects must meet the following inclusion criteria:
Exclusion Criteria: Subjects will be excluded from the study if they:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00614289 | ||||
| Responsible Party | Adelaide A. Hebert, MD, University of Texas Health Science Center-Houston, Dermatology Clincial Research Center | ||||
| Study ID Numbers ICMJE | HSC-MS-06-0347, NIH Grant 1R43AR525441-1A1 | ||||
| Study Sponsor ICMJE | Biomedical Development Corporation | ||||
| Collaborators ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Investigators ICMJE |
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| Information Provided By | Biomedical Development Corporation | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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