Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
Study NCT ID:
NCT02224950
Status:
WITHDRAWN
Last Update Posted:
2017-03-24
First Post:
2014-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Examine the Benefits of Fabric Made With Lyocell/Chitosan/Ceramide in the Treatment of Children With Mild to Moderate Eczema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Withdrawn from IRB before approval', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-21', 'studyFirstSubmitDate': '2014-08-21', 'studyFirstSubmitQcDate': '2014-08-22', 'lastUpdatePostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Trans-epidermal water loss', 'timeFrame': '3 weeks', 'description': 'Is trans-epidermal water loss affected by the fabric combination?'}], 'primaryOutcomes': [{'measure': 'Benefit of ceramide embedded fabric', 'timeFrame': '3 weeks', '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.'}], 'secondaryOutcomes': [{'measure': 'Bacterial growth', 'timeFrame': '3 weeks', 'description': 'Is bacterial growth affected by the fabric combination?'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atopic dermatitis', 'eczema', 'alternative therapy', 'complementary therapy', 'moisturizer'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 3 months to 5 years\n* Mild or moderate atopic dermatitis, as determined by Investigator Global Assessment Criteria\n\nExclusion Criteria:\n\n* Non-English speaking subjects/families\n* Families unable to complete study requirements'}, 'identificationModule': {'nctId': 'NCT02224950', 'briefTitle': 'Study to Examine the Benefits of Fabric Made With Lyocell/Chitosan/Ceramide in the Treatment of Children With Mild to Moderate Eczema', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Study to Examine the Benefits of Fabric Made With Lyocell/Chitosan/Ceramide in the Treatment of Children With Mild to Moderate Eczema', 'orgStudyIdInfo': {'id': 'UofMLyocell'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Non-medicated Emollient with no Clothing Covering Upper Limb - "Baseline/Control" Cells', 'interventionNames': ['Device: Non-medicated Emollient plus Lyocell/Chitosan Sleeve']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sleeve 2', 'description': 'Non-medicated Emollient plus Lyocell/Chitosan Sleeve', 'interventionNames': ['Other: Non-medicated Emollient plus Cotton Sleeve']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Sleeve', 'description': 'Non-medicated Emollient plus Cotton Sleeve', 'interventionNames': ['Other: Placebo Sleeve']}], 'interventions': [{'name': 'Non-medicated Emollient plus Lyocell/Chitosan Sleeve', 'type': 'DEVICE', 'armGroupLabels': ['Control']}, {'name': 'Non-medicated Emollient plus Cotton Sleeve', 'type': 'OTHER', 'armGroupLabels': ['Sleeve 2']}, {'name': 'Placebo Sleeve', 'type': 'OTHER', 'armGroupLabels': ['Placebo Sleeve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Kristen Hook, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}