Novel Topical Treatment of Hand Dermatitis (Eczema)
This study is designed as a prospective, randomized, double-blind right/left comparison of Epikeia coatings to improve hand dermatitis.
|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|
- 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 ]
- Ordinal scales measuring subjective efficacy, pain and itching. [ Time Frame: 85 Days ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2006|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Device: Epikeia Coatings
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614289
|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|