Ignite Creation Date:
2024-05-06 @ 3:10 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02224950
Status:
WITHDRAWN
Last Update Posted:
2017-03-24
First Post:
2014-08-21
Brief Title:
Study to Examine the Benefits of Fabric Made With LyocellChitosanCeramide in the Treatment of Children With Mild to Moderate Eczema
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Study to Examine the Benefits of Fabric Made With LyocellChitosanCeramide in the Treatment of Children With Mild to Moderate Eczema
Status:
WITHDRAWN
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn from IRB before approval
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will primarily focus on evaluating the benefits of using a lyocellchitosanceramide 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 lyocellchitosanceramide 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
Detailed Description:
The study will be evaluated using the following four variables an eczema severity index amountseverity of itching bacteria levels in the affected areas of skin and amount of water loss in the affected areas The eczema severity will be scored using the EASI upper limb subscale itch will be assessed with a Visual Analog Scale for itch the skin will be swabbed for bacterial cultures and results are quantified based on microbiology lab standards to be mild moderate or heavy growth of the bacteria identified and transepidermal water loss TEWL will be measured using a tewametercapacitive moisture sensor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None