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

NCT02224950 | Withdrawn

• 1 other identifier: UofMLyocell
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; eczema; alternative therapy; complementary therapy; moisturizer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bacterial growth

  3 weeks

Other Outcomes (1)

• Trans-epidermal water loss

  3 weeks

Study Arms (3)

Control

PLACEBO COMPARATOR

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

Device: Non-medicated Emollient plus Lyocell/Chitosan Sleeve

Sleeve 2

ACTIVE COMPARATOR

Non-medicated Emollient plus Lyocell/Chitosan Sleeve

Other: Non-medicated Emollient plus Cotton Sleeve

Placebo Sleeve

PLACEBO COMPARATOR

Non-medicated Emollient plus Cotton Sleeve

Other: Placebo Sleeve

Interventions

Non-medicated Emollient plus Lyocell/Chitosan Sleeve DEVICE

Control

Non-medicated Emollient plus Cotton Sleeve OTHER

Sleeve 2

Placebo Sleeve OTHER

Placebo Sleeve

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 3 months to 5 years
• Mild or moderate atopic dermatitis, as determined by Investigator Global Assessment Criteria

You may not qualify if:

• Non-English speaking subjects/families
• Families unable to complete study requirements

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kristen Hook, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 25, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 24, 2017

Record last verified: 2017-03

Locations

US (1)