Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT00690105
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 Adult Atopic Eczema of the Face
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D019066', 'term': 'Facies'}], '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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 577}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2005-07', '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': '2005-07', '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 local mEASI score (mLEASI) compared to Baseline (day 1).', 'timeFrame': '3 weeks'}], 'secondaryOutcomes': [{'measure': "Percentage of patients no longer presenting with 'facial' erythema at day 7 and day 21", 'timeFrame': '1 week and 3 weeks'}, {'measure': 'Assessment of facial pruritus at day 1, day 7 and day 21', 'timeFrame': '1 week and 3 weeks'}, {'measure': "Global assessment of clinical response on the 'face' by the physician at day 7 and day 21", 'timeFrame': '1 week and 3 weeks'}, {'measure': "Global assessment of clinical response on the 'face' by the patient at day 7 and day 21", 'timeFrame': '1 week and 3 weeks'}, {'measure': "Patient's quality of life at day 1 and day 21", 'timeFrame': '1 week and 3 weeks'}, {'measure': 'mLEASI score values at day 7 and day 21', 'timeFrame': '1 week and 3 weeks'}, {'measure': "Physician's assessment of individual signs", 'timeFrame': '1 week and 3 weeks'}, {'measure': 'Quality of sleep at day 1, day 7 and day 21', 'timeFrame': '1 week and 3 weeks'}, {'measure': 'Affected surface area assessment at day 1, day 7 and day 21', 'timeFrame': '1 week and 3 weeks'}, {'measure': 'Number of patients using the ointment from the other group to treat facial lesions after day 21', 'timeFrame': '3 weeks'}, {'measure': 'Incidences of adverse events during the study period', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dermatitis, Atopic', 'Dermatologic Agents', 'Topical Drug Administration', 'Tacrolimus', 'Calcineurin', 'Corticosteroid', 'Fluticasone propionate', 'Face'], 'conditions': ['Dermatitis, Atopic']}, 'descriptionModule': {'briefSummary': 'Patients with facial 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 or change for the other ointment.', 'detailedDescription': 'Treatments were to be applied twice daily over all lesions on the face (except for the eyelids) 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Moderate to severe AD (Rajka \\& Langeland score) with lesions to the head and neck defined as 'red face' or 'facial eczema': erythema affecting at least 10% of the surface of the 'face' (head, neck, chest, nape of neck), due to long-term AD\n* At least two flare-ups of 'facial' eczema during the 12 months prior to inclusion and, in the investigator's opinion, conventional treatment had proved ineffective or poorly tolerated\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* Seborrheic dermatitis or contact dermatitis affecting the 'face', or any other facial erythema of non-atopic origin\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 0.1% 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 who participated at the same time in another clinical study or who had participated in another clinical study within 28 days prior to inclusion in the study\n* Any type of substance abuse (including that of drugs and alcohol) or any mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up\n* Serologically-proven HIV positivity"}, 'identificationModule': {'nctId': 'NCT00690105', 'briefTitle': 'Protopic Ointment in Adult Atopic Eczema of the Face', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': "Comparative, Multicentre, Randomized, Double-blind Study to Assess the Efficacy of Tacrolimus 0.1% Ointment Versus Fluticasone 0.005% Ointment in Adult Patients Suffering From Moderate to Severe Atopic Dermatitis and Presenting With So-called 'Red Face' Lesions of the Head and Neck.", 'orgStudyIdInfo': {'id': 'FG-506-06-FR-04'}, 'secondaryIdInfos': [{'id': 'EUDRACT #: 2004-002477-23'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: tacrolimus 0.1%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: fluticasone 0.005 %']}], 'interventions': [{'name': 'tacrolimus 0.1%', 'type': 'DRUG', 'otherNames': ['Protopic® 0.1%'], 'description': 'ointment', 'armGroupLabels': ['A']}, {'name': 'fluticasone 0.005 %', 'type': 'DRUG', 'otherNames': ['Flixovate® 0.005%'], 'description': 'ointment', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06202', 'city': 'Nice', 'country': 'France', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Central Contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Europe B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}