Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT00689832
Status:
COMPLETED
Last Update Posted:
2014-09-01
First Post:
2008-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Protopic Ointment in Children Atopic Eczema
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 487}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-28', 'studyFirstSubmitDate': '2008-06-02', 'studyFirstSubmitQcDate': '2008-06-03', 'lastUpdatePostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their modified Eczema Area and Severity Index (mEASI) in comparison to day 1', 'timeFrame': '3 weeks'}], 'secondaryOutcomes': [{'measure': 'mEASI and EASI scores at each visit and percentage change with respect to day 1', 'timeFrame': '1 week and 3 weeks'}, {'measure': 'Global assessment of clinical response by the physician at each visit after day 1', 'timeFrame': '1 week and 3 weeks'}, {'measure': 'Global assessment of clinical response by the patient/parents at each visit after day 1', 'timeFrame': '1 week and 3 weeks'}, {'measure': 'All clinical signs, including sleep quality, severity of pruritus and body surface area affected at each visit', 'timeFrame': '1 week and 3 weeks'}, {'measure': "Compliance with the treatment assessed from the patient's diary", 'timeFrame': '1 week and 3 weeks'}, {'measure': "Patient's quality of life assessed at day 1 and day 21", 'timeFrame': '3 weeks'}, {'measure': 'Incidence of adverse events during the study', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dermatitis, Atopic', 'Dermatologic Agents', 'Topical Drug Administration', 'Tacrolimus', 'Calcineurin', 'Corticosteroid', 'Fluticasone propionate', 'Child'], 'conditions': ['Dermatitis, Atopic']}, 'descriptionModule': {'briefSummary': 'Children with atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed.', 'detailedDescription': 'Treatments were to be applied twice daily until clearance, for a maximum of 3 weeks and then, in case of uncleared residual lesions, once daily for up to 3 further weeks. In the event of a flare-up the treatment was to be resumed twice a day until the end of the study.\n\nStatistical methods: An interim analysis was performed on 30% of the planned total sample size, i.e. 140 included patients who had completed the study, to reassess the assumptions made during the planning phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children with moderate to severe atopic dermatitis (Rajka \\& Langeland score greater than or equal to 4.5) and who had responded insufficiently to conventional therapies\n* Female patients of childbearing age: effective means of contraception throughout the period of the study and for four weeks following the end of the study\n* Informed consent\n* Therapeutic washout for atopic dermatitis treatments\n\nExclusion Criteria:\n\n* Genetic epidermal barrier defect, such as Netherton's syndrome, or suffering from erythroderma\n* Any female patients who were pregnant or breast-feeding\n* Clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum\n* Superinfected eczema\n* Known hypersensitivity to macrolides or to any other excipient in tacrolimus ointment\n* Known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation\n* Ulcerated lesions, of whatever type\n* Moderate to severe acne or rosacea\n* Patients participating at the same time in another clinical study or who have participated in another clinical study within 28 days of the start of this study\n* substance abuse (including that of drugs and alcohol) or mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up\n* Known serologically proven HIV positivity"}, 'identificationModule': {'nctId': 'NCT00689832', 'briefTitle': 'Protopic Ointment in Children Atopic Eczema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Comparative, Multicentre, Randomised, Double-blind Study to Assess the Efficacy of Tacrolimus 0.03% Ointment Versus Fluticasone 0.005% Ointment in Children Aged 2 Years or Over Suffering From Moderate to Severe Atopic Dermatitis.', 'orgStudyIdInfo': {'id': 'FG-506-06-FR-05'}, 'secondaryIdInfos': [{'id': 'EUDRACT #:2004-002478-47'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: Tacrolimus 0.03%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: Fluticasone 0.005%']}], 'interventions': [{'name': 'Tacrolimus 0.03%', 'type': 'DRUG', 'otherNames': ['Protopic® 0.03%'], 'description': 'ointment', 'armGroupLabels': ['A']}, {'name': 'Fluticasone 0.005%', 'type': 'DRUG', 'otherNames': ['Flixovate® 0.005%'], 'description': 'ointment', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Central Contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Europe B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}