Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis, eczema, alternative therapy, complementary therapy, moisturizer
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.
Interventions
DEVICENon-medicated Emollient plus Lyocell/Chitosan Sleeve
OTHERNon-medicated Emollient plus Cotton Sleeve
OTHERPlacebo Sleeve
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to 5 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Bacterial growth | 3 weeks | Is bacterial growth affected by the fabric combination? |
Other
| Measure | Time frame | Description |
|---|---|---|
| Trans-epidermal water loss | 3 weeks | Is trans-epidermal water loss affected by the fabric combination? |
Countries
United States
Outcome results
None listed