Study to Examine the Benefits of Fabric Made With Lyocell/Chitosan/Ceramide in the Treatment of Children With Mild to Moderate Eczema
NCT02224950 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2017-03-24
Summary
The study will primarily focus on evaluating the benefits of using a lyocell/chitosan/ceramide fabric as a treatment for young children with mild or moderate eczema. More specifically, the study will focus on the upper limb area in these patients and will examine whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can improve eczema symptoms compared with wearing a cotton sleeve, no sleeve, or the lyocell / chitosan combination. Patients will be evaluated at 3 intervals over a 3-week period using the following four variables: an eczema severity index, amount of itching, bacteria levels in the affected areas of skin, and amount of water loss in the affected areas.
Conditions
Interventions
- DEVICE
-
Non-medicated Emollient plus Lyocell/Chitosan Sleeve
- OTHER
-
Non-medicated Emollient plus Cotton Sleeve
- OTHER
-
Placebo Sleeve
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Kristen Hook, MD · University of Minnesota
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Months
- Max Age
- 5 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- United States
Study Locations
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