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

Primary Purpose

Atopic Dermatitis

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Non-medicated Emollient plus Lyocell/Chitosan Sleeve

Non-medicated Emollient plus Cotton Sleeve

Placebo Sleeve

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, eczema, alternative therapy, complementary therapy, moisturizer

Eligibility Criteria

3 Months - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Control

Sleeve 2

Placebo Sleeve

Arm Description

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

Non-medicated Emollient plus Lyocell/Chitosan Sleeve

Non-medicated Emollient plus Cotton Sleeve

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Bacterial growth

Is bacterial growth affected by the fabric combination?

Full Information

NCT ID

NCT02224950

First Posted

August 21, 2014

Last Updated

March 21, 2017

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT02224950

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Withdrawn from IRB before approval

Study Start Date

November 2014 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

Atopic dermatitis, eczema, alternative therapy, complementary therapy, moisturizer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Sleeve 2

Arm Type

Active Comparator

Arm Description

Non-medicated Emollient plus Lyocell/Chitosan Sleeve

Arm Title

Placebo Sleeve

Arm Type

Placebo Comparator

Arm Description

Non-medicated Emollient plus Cotton Sleeve

Intervention Type

Device

Intervention Name(s)

Non-medicated Emollient plus Lyocell/Chitosan Sleeve

Intervention Type

Other

Intervention Name(s)

Non-medicated Emollient plus Cotton Sleeve

Intervention Type

Other

Intervention Name(s)

Placebo Sleeve

Primary Outcome Measure Information:

Title

Benefit of ceramide embedded fabric

Description

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.

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Bacterial growth

Description

Is bacterial growth affected by the fabric combination?

Time Frame

3 weeks

Other Pre-specified Outcome Measures:

Title

Trans-epidermal water loss

Description

Is trans-epidermal water loss affected by the fabric combination?

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristen Hook, MD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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