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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02224950
• Other study ID #: UofMLyocell
• Status: Withdrawn
• Phase: N/A
• First received: August 21, 2014
• Last updated: March 21, 2017
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Device:
• Non-medicated Emollient plus Lyocell/Chitosan Sleeve

Other:
• Non-medicated Emollient plus Cotton Sleeve

• Placebo Sleeve

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Trans-epidermal water loss	Is trans-epidermal water loss affected by the fabric combination?	3 weeks
Primary	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	Bacterial growth	Is bacterial growth affected by the fabric combination?	3 weeks