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

University of Minnesota (UMN)

Status: Withdrawn

Conditions: Atopic Dermatitis

Treatments: Device: Non-medicated Emollient plus Lyocell/Chitosan Sleeve; Other: Non-medicated Emollient plus Cotton Sleeve; Other: Placebo Sleeve

Study type: Interventional

Funder types: Other

Identifiers

NCT02224950

UofMLyocell

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 3 months to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Non-medicated Emollient with no Clothing Covering Upper Limb - "Baseline/Control" Cells

Treatment:

Device: Non-medicated Emollient plus Lyocell/Chitosan Sleeve

Sleeve 2

Active Comparator group

Description:

Non-medicated Emollient plus Lyocell/Chitosan Sleeve

Treatment:

Other: Non-medicated Emollient plus Cotton Sleeve

Placebo Sleeve

Placebo Comparator group

Description:

Non-medicated Emollient plus Cotton Sleeve

Treatment:

Other: Placebo Sleeve