Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-02-23 @ 11:57 PM
Study NCT ID:
NCT02534428
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2015-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wool Clothing for the Management of Childhood Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-24', 'studyFirstSubmitDate': '2015-08-11', 'studyFirstSubmitQcDate': '2015-08-24', 'lastUpdatePostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'change in moisturiser use (times per day)', 'timeFrame': 'at 6 weeks'}, {'measure': 'change in moisturiser use (times per day)', 'timeFrame': 'at 3 weeks'}, {'measure': 'change in topical steroid use (times per day)', 'timeFrame': 'at 6 weeks'}, {'measure': 'change in topical steroid use (times per day)', 'timeFrame': 'at 3 weeks'}], 'primaryOutcomes': [{'measure': 'Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)', 'timeFrame': 'at 6 weeks', 'description': 'blinded assessor administered SCORAD'}], 'secondaryOutcomes': [{'measure': 'Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)', 'timeFrame': 'at 3 weeks', 'description': 'blinded assessor administered SCORAD'}, {'measure': 'Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)', 'timeFrame': 'at 6 weeks', 'description': 'blinded assessor administered ADSI'}, {'measure': 'Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)', 'timeFrame': 'at 3 weeks', 'description': 'blinded assessor administered ADSI'}, {'measure': "Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)", 'timeFrame': 'at 6 weeks'}, {'measure': "Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)", 'timeFrame': 'at 3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dermatitis, Atopic']}, 'referencesModule': {'references': [{'pmid': '16766885', 'type': 'BACKGROUND', 'citation': 'Ricci G, Patrizi A, Bellini F, Medri M. Use of textiles in atopic dermatitis: care of atopic dermatitis. Curr Probl Dermatol. 2006;33:127-43. doi: 10.1159/000093940.'}, {'pmid': '18512638', 'type': 'BACKGROUND', 'citation': 'Mason R. Fabrics for atopic dermatitis. J Fam Health Care. 2008;18(2):63-5.'}, {'pmid': '3884253', 'type': 'BACKGROUND', 'citation': 'Hatch KL, Maibach HI. Textile fiber dermatitis. Contact Dermatitis. 1985 Jan;12(1):1-11. doi: 10.1111/j.1600-0536.1985.tb01030.x.'}, {'pmid': '24720530', 'type': 'BACKGROUND', 'citation': 'Gelmetti C, Wollenberg A. Atopic dermatitis - all you can do from the outside. Br J Dermatol. 2014 Jul;170 Suppl 1:19-24. doi: 10.1111/bjd.12957. Epub 2014 May 9.'}, {'pmid': '3652686', 'type': 'RESULT', 'citation': 'Bendsoe N, Bjornberg A, Asnes H. Itching from wool fibres in atopic dermatitis. Contact Dermatitis. 1987 Jul;17(1):21-2. doi: 10.1111/j.1600-0536.1987.tb02638.x.'}]}, 'descriptionModule': {'briefSummary': 'The study is a sequentially recruited, cross-over-cohort, outpatient-based evaluation of the effectiveness of wool clothing, as compared to standard clothing, in reducing the severity of childhood atopic dermatitis over two consecutive six-week periods.', 'detailedDescription': "The study will aim for a sample size of approximately 40 patients between the ages of 0 and 3 years of children referred to the Dermatology Department at the Royal Children's Hospital for management of mild to moderate atopic dermatitis. They will be sequentially recruited and randomized to the wool-standard clothing arm or standard clothing-wool arm.\n\nThe study will run for 12 weeks for each participant with two 6-week periods, either of wool followed by standard clothing or standard followed by wool clothing. Participants will be assessed by a blinded trained researcher during this time, at their initial appointment, 3 weeks, 6 weeks, 9 weeks and 12 weeks.\n\nThe primary outcome is change in the severity of atopic eczema at 6 weeks. Severity of atopic eczema will be measured using the Scoring Atopic Dermatitis (SCORAD) index.\n\nSecondary outcomes include the change in the severity of eczema using the SCORAD at 3 weeks and the Atopic Dermatitis Severity Index (ADSI) score at 3 and 6 weeks and quality of life assessment using the Dermatology Life Quality Index (DLQI) at 3 and 6 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* mild to moderate eczema as determined by a SCORAD of 1-50 at their initial visit\n* has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf\n* is capable of returning for review having had education through the Royal Children's Hospital eczema workshop\n\nExclusion Criteria:\n\n* known reactions to wool products\n* is unable to attend visits\n* has unstable eczema defined by treatment escalation or increased topical anti-inflammatory use in the preceding 2 months"}, 'identificationModule': {'nctId': 'NCT02534428', 'briefTitle': 'Wool Clothing for the Management of Childhood Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Murdoch Childrens Research Institute'}, 'officialTitle': 'The Effects of Superfine Merino Wool in the Management of Childhood Atopic Dermatitis', 'orgStudyIdInfo': {'id': '34037 A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'wool-first (wool-standard)', 'description': 'superfine merino wool clothing to be worn for 6 weeks followed by 6 weeks of standard clothing (cotton)', 'interventionNames': ['Other: wool clothing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cotton-first (standard-wool)', 'description': 'standard (cotton) clothing to be work for 6 weeks followed by 6 weeks of superfine merino wool clothing', 'interventionNames': ['Other: wool clothing']}], 'interventions': [{'name': 'wool clothing', 'type': 'OTHER', 'description': 'superfine merino wool ensembles for baby wear', 'armGroupLabels': ['cotton-first (standard-wool)', 'wool-first (wool-standard)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'John C Su, FRACP FACD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Murdoch Childrens Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Murdoch Childrens Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Australian Wool Innovation Limited', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}