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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

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ClinicalTrials.gov Identifier: NCT02224950
Recruitment Status : Withdrawn (Withdrawn from IRB before approval)
First Posted : August 25, 2014
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Device: Non-medicated Emollient plus Lyocell/Chitosan Sleeve Other: Non-medicated Emollient plus Cotton Sleeve Other: Placebo Sleeve Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Bacterial growth [ Time Frame: 3 weeks ]
    Is bacterial growth affected by the fabric combination?


Other Outcome Measures:
  1. Trans-epidermal water loss [ Time Frame: 3 weeks ]
    Is trans-epidermal water loss affected by the fabric combination?



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224950


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Kristen Hook, MD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02224950     History of Changes
Other Study ID Numbers: UofMLyocell
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Atopic dermatitis
eczema
alternative therapy
complementary therapy
moisturizer

Additional relevant MeSH terms:
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Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Chitosan
Emollients
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants
Dermatologic Agents