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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Device: Non-medicated Emollient plus Lyocell/Chitosan Sleeve
* Other: Non-medicated Emollient plus Cotton Sleeve
* Other: Placebo Sleeve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 3 months to 5 years Mild or moderate atopic dermatitis, as determined by Investigator Global Assessment Criteria Exclusion Criteria: Non-English speaking subjects/families Families unable to complete study requirements

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Non-medicated Emollient with no Clothing Covering Upper Limb - Baseline/Control Cells | Device: Non-medicated Emollient plus Lyocell/Chitosan Sleeve<br> <br> |
| Active Comparator: Sleeve 2<br>Non-medicated Emollient plus Lyocell/Chitosan Sleeve | Other: Non-medicated Emollient plus Cotton Sleeve<br> <br> |
| Placebo Comparator: Placebo Sleeve<br>Non-medicated Emollient plus Cotton Sleeve | Other: Placebo Sleeve<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benefit of ceramide embedded fabric | 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. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial growth | Is bacterial growth affected by the fabric combination? | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic dermatitis, eczema, alternative therapy, complementary therapy, moisturizer