Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-17 @ 10:52 PM
Study NCT ID:
NCT01745159
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
2012-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-04', 'studyFirstSubmitDate': '2012-12-06', 'studyFirstSubmitQcDate': '2012-12-06', 'lastUpdatePostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first DE (disease exacerbation)', 'timeFrame': '6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period)'}], 'secondaryOutcomes': [{'measure': 'Number of DEs during the DCP', 'timeFrame': '6 months of DCP (Disease Control Period)'}, {'measure': 'Eczema Area and Severity Index (EASI)', 'timeFrame': '6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)'}, {'measure': "Investigator's Global Assessment (IGA)", 'timeFrame': '6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)'}, {'measure': 'Duration of DE during DCP', 'timeFrame': '6 months of DCP (Disease Control Period)'}, {'measure': 'The overall efficacy during OLP', 'timeFrame': 'After 2 to 6 weeks of OLP (Open Label Period)'}, {'measure': 'Quantity of tacrolimus ointment used', 'timeFrame': '6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)'}, {'measure': 'Incidence of adverse events', 'timeFrame': '6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tacrolimus', 'Protopic', 'pediatric', 'atopic dermatitis', 'China'], 'conditions': ['Moderate/Severe Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.', 'detailedDescription': 'This study includes three periods. First a screening period of up to one week. Second an open-label treatment period of up to six weeks where all participants apply tacrolimus ointment. Third an open-label disease control period of up to six months where half of the participants apply tacrolimus ointment and the other half of the participants do not apply treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosed as AD according to Williams diagnostic criteria.\n2. Moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland\n3. At least approximately 10 % of body area\n4. Patient is able to reach the centre within 3 days in case of a disease exacerbation.\n5. Patient's legal representative(s) has/have given written informed consent. If the patient is capable of understanding the purposes and risks of the trial, written informed consent has been obtained from the patient as well"}, 'identificationModule': {'nctId': 'NCT01745159', 'briefTitle': 'Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Proactive Treatment With Tacrolimus Ointment in Children With Moderate/Severe Atopic Dermatitis: A Randomized, Multicenter, Open-label Study', 'orgStudyIdInfo': {'id': 'ACN-PRT-AD-12-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'continued tacrolimus treatment', 'description': 'children with moderate/severe atopic dermatitis treated with tacrolimus ointment and continuing to apply tacrolimus ointment during disease control period.', 'interventionNames': ['Drug: tacrolimus']}, {'type': 'NO_INTERVENTION', 'label': 'no additional treatment', 'description': 'children with moderate/severe atopic dermatitis treated with tacrolimus ointment and with no additional treatment during disease control period.'}], 'interventions': [{'name': 'tacrolimus', 'type': 'DRUG', 'otherNames': ['Protopic'], 'armGroupLabels': ['continued tacrolimus treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'country': 'China', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Guangzhou', 'country': 'China', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma China, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}