Study to Examine the Benefits of Fabric Made With Lyocell/Chitosan/Ceramide in the Treatment of Children With Mild to Moderate Eczema
| Status: | Completed |
|---|---|
| Conditions: | Psoriasis, Dermatology, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | Any - 5 |
| Updated: | 4/2/2016 |
| Start Date: | November 2014 |
| End Date: | December 2015 |
| Contact: | Kristen Hook, MD |
| Email: | hans1635@umn.edu |
| Phone: | 612-625-8625 |
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.
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.
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.
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.
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
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