Study to Examine the Benefits of Fabric Made With Lyocell/Chitosan/Ceramide in the Treatment of Children With Mild to Moderate Eczema

Not Applicable

Withdrawn

• Conditions: Atopic Dermatitis
• Interventions: Other: Non-medicated Emollient plus Cotton Sleeve; Device: Non-medicated Emollient plus Lyocell/Chitosan Sleeve; Other: Placebo Sleeve

• Registration Number: NCT02224950
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed Description

The study will be evaluated using the following four variables: an eczema severity index, amount/severity 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 tewameter/capacitive moisture sensor.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-25
• Study Start: 2014-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age 3 months to 5 years
• Mild or moderate atopic dermatitis, as determined by Investigator Global Assessment Criteria

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Exclusion Criteria

• Non-English speaking subjects/families
• Families unable to complete study requirements

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleeve 2	Non-medicated Emollient plus Cotton Sleeve	Non-medicated Emollient plus Lyocell/Chitosan Sleeve
Control	Non-medicated Emollient plus Lyocell/Chitosan Sleeve	Non-medicated Emollient with no Clothing Covering Upper Limb - "Baseline/Control" Cells
Placebo Sleeve	Placebo Sleeve	Non-medicated Emollient plus Cotton Sleeve

Primary Outcome Measures

Name	Time	Method
Benefit of ceramide embedded fabric	3 weeks	Whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can improve eczema symptoms compared to wearing a cotton sleeve, no sleeve, or the lyocell / chitosan combination.

Secondary Outcome Measures

Name	Time	Method
Bacterial growth	3 weeks	Is bacterial growth affected by the fabric combination?

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States