Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 7:51 AM
Study NCT ID:
NCT00801957
Status:
COMPLETED
Last Update Posted:
2014-09-18
First Post:
2008-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D008581', 'term': 'Meningitis'}], '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'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-17', 'studyFirstSubmitDate': '2008-12-03', 'studyFirstSubmitQcDate': '2008-12-03', 'lastUpdatePostDateStruct': {'date': '2014-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with serum bactericidal antibody titer of ≥ 8', 'timeFrame': '5 weeks'}], 'secondaryOutcomes': [{'measure': 'Assessment of other immunological parameters', 'timeFrame': '7 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atopic dermatitis', 'meningitis', 'vaccination', 'tacrolimus', 'steroids', 'equivalence response', 'meningococcal vaccine'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '16798785', 'type': 'BACKGROUND', 'citation': 'Hofman T, Cranswick N, Kuna P, Boznanski A, Latos T, Gold M, Murrell DF, Gebauer K, Behre U, Machura E, Olafsson J, Szalai Z; International Tacrolimus Ointment Study Group. Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children. Arch Dis Child. 2006 Nov;91(11):905-10. doi: 10.1136/adc.2006.094276. Epub 2006 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'Seven-month study in pediatric patients (2-11 years) with moderate to severe AD who were considered to benefit from vaccination to prevent invasive disease caused by Neisseria meningitides serogroup C.', 'detailedDescription': 'At the week 1 visit, the patients were vaccinated with a protein-conjugated vaccine against meningitis. All patients received a challenge at the month 6 visit with a low dose of meningo polysaccharide vaccine. A control group of healthy subjects (not suffering from atopic dermatitis) received only the vaccination and the challenge dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with moderate to severe atopic dermatitis and in need for treatment\n* Patients require vaccination to prevent invasive disease caused by Neisseria meningitidis serogroup C\n\nExclusion Criteria:\n\n* Patients have known hypersensitivity to macrolides, tacrolimus and any component of the vaccine\n* Patients have an acute severe febrile illness, genetic epidermal barrier defect such as Netherton's syndrome or generalized erythroderma, a skin infection on the affected and to be treated area\n* Patients have already received a meningo polysaccharide or conjugated vaccine against meningitis"}, 'identificationModule': {'nctId': 'NCT00801957', 'briefTitle': 'Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Double Blind, Multicentre, Randomised, Parallel Group Study to Demonstrate the Equivalence of the Response to Vaccination of a Tacrolimus Ointment Regimen to a Steroid Ointment Regimen in Children With Moderate to Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'FG-506-06-27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'tacrolimus ointment 0.03%', 'interventionNames': ['Drug: tacrolimus ointment 0.03%', 'Biological: Meningitec', 'Biological: AC VAX']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'hydrocortisone acetate 1% and butyrate 0.1%', 'interventionNames': ['Drug: hydrocortisone acetate ointment 1%', 'Drug: hydrocortisone butyrate ointment 0.1%', 'Biological: Meningitec', 'Biological: AC VAX']}, {'type': 'OTHER', 'label': '3', 'description': 'Control group vaccination and challenge dose only', 'interventionNames': ['Biological: Meningitec', 'Biological: AC VAX']}], 'interventions': [{'name': 'tacrolimus ointment 0.03%', 'type': 'DRUG', 'otherNames': ['Protopic 0.03%'], 'description': 'topical application', 'armGroupLabels': ['1']}, {'name': 'hydrocortisone acetate ointment 1%', 'type': 'DRUG', 'otherNames': ['ATC code H02AB09'], 'description': 'topical application', 'armGroupLabels': ['2']}, {'name': 'hydrocortisone butyrate ointment 0.1%', 'type': 'DRUG', 'otherNames': ['ATC code H02AB09'], 'description': 'topical application', 'armGroupLabels': ['2']}, {'name': 'Meningitec', 'type': 'BIOLOGICAL', 'description': 'im injection', 'armGroupLabels': ['1', '2', '3']}, {'name': 'AC VAX', 'type': 'BIOLOGICAL', 'description': 'im injection', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '4217', 'city': 'Benowa', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -28.0077, 'lon': 153.38583}}, {'zip': '4152', 'city': 'Carina Heights', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.50721, 'lon': 153.09126}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '5006', 'city': 'North Adelaide', 'state': 'South Australia', 'country': 'Australia', 'geoPoint': {'lat': -34.90733, 'lon': 138.59141}}, {'zip': '3053', 'city': 'Carlton', 'state': 'Victoria', 'country': 'Australia', 'geoPoint': {'lat': -37.8, 'lon': 144.96667}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6160', 'city': 'Fremantle', 'state': 'Western Australia', 'country': 'Australia', 'geoPoint': {'lat': -32.05632, 'lon': 115.74557}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '75015', 'city': 'Bretten', 'country': 'Germany', 'geoPoint': {'lat': 49.03685, 'lon': 8.70745}}, {'zip': '77955', 'city': 'Ettenheim', 'country': 'Germany', 'geoPoint': {'lat': 48.25696, 'lon': 7.81247}}, {'zip': '36129', 'city': 'Gersfeld', 'country': 'Germany', 'geoPoint': {'lat': 50.45138, 'lon': 9.91422}}, {'zip': '77694', 'city': 'Kehl', 'country': 'Germany', 'geoPoint': {'lat': 48.57297, 'lon': 7.81523}}, {'zip': '88069', 'city': 'Tettnang', 'country': 'Germany', 'geoPoint': {'lat': 47.66857, 'lon': 9.59132}}, {'zip': '1089', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '7624', 'city': 'Pécs', 'country': 'Hungary', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '6720', 'city': 'Szeged', 'country': 'Hungary', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '201', 'city': 'Kopavogur', 'country': 'Iceland', 'geoPoint': {'lat': 64.11234, 'lon': -21.91298}}, {'city': 'Saint Julians', 'country': 'Malta'}, {'zip': '58-540', 'city': 'Karpacz', 'country': 'Poland', 'geoPoint': {'lat': 50.77669, 'lon': 15.75594}}, {'zip': '30-633', 'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '90-153', 'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '91-347', 'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '45-372', 'city': 'Opole', 'country': 'Poland', 'geoPoint': {'lat': 50.67119, 'lon': 17.92604}}, {'zip': '60-214', 'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '34-700', 'city': 'Rabka-Zdrój', 'country': 'Poland', 'geoPoint': {'lat': 49.60889, 'lon': 19.96654}}, {'zip': '01-219', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '04-740', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-376', 'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '51-136', 'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '41-800', 'city': 'Zabrze', 'country': 'Poland', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}, {'zip': '95-100', 'city': 'Zgierz', 'country': 'Poland', 'geoPoint': {'lat': 51.85561, 'lon': 19.40623}}, {'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4430', 'city': 'Porto', 'country': 'Portugal', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'overallOfficials': [{'name': 'Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Europe B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}