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

March 21, 2017 updated by: University of Minnesota
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
Non-medicated Emollient with no Clothing Covering Upper Limb - "Baseline/Control" Cells
Device: Non-medicated Emollient plus Lyocell/Chitosan Sleeve
ACTIVE_COMPARATOR: Sleeve 2
Non-medicated Emollient plus Lyocell/Chitosan Sleeve
Other: Non-medicated Emollient plus Cotton Sleeve
PLACEBO_COMPARATOR: Placebo Sleeve
Non-medicated Emollient plus Cotton Sleeve
Other: Placebo Sleeve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Benefit of ceramide embedded fabric
Time Frame: 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.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial growth
Time Frame: 3 weeks
Is bacterial growth affected by the fabric combination?
3 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trans-epidermal water loss
Time Frame: 3 weeks
Is trans-epidermal water loss affected by the fabric combination?
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Kristen Hook, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

August 21, 2014

First Submitted That Met QC Criteria

August 22, 2014

First Posted (ESTIMATE)

August 25, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UofMLyocell

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atopic Dermatitis

Clinical Trials on Non-medicated Emollient plus Lyocell/Chitosan Sleeve

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe