Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-09 @ 6:29 AM
Study NCT ID:
NCT00667056
Status:
COMPLETED
Last Update Posted:
2014-09-18
First Post:
2008-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Safety and Efficacy of Tacrolimus Ointment in Treating Chronic Allergic Contact Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003872', 'term': 'Dermatitis'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-17', 'studyFirstSubmitDate': '2008-04-23', 'studyFirstSubmitQcDate': '2008-04-23', 'lastUpdatePostDateStruct': {'date': '2014-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Success using the Physician's Global Assessment (PGA)", 'timeFrame': '8 Weeks'}], 'secondaryOutcomes': [{'measure': 'Investigator and subject ACD Sign and Symptoms', 'timeFrame': '8 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Allergic Contact Dermatitis', 'Protopic'], 'conditions': ['Dermatitis']}, 'referencesModule': {'references': [{'pmid': '16781290', 'type': 'BACKGROUND', 'citation': 'Belsito D, Wilson DC, Warshaw E, Fowler J, Ehrlich A, Anderson B, Strober BE, Willetts J, Rutledge ES. A prospective randomized clinical trial of 0.1% tacrolimus ointment in a model of chronic allergic contact dermatitis. J Am Acad Dermatol. 2006 Jul;55(1):40-6. doi: 10.1016/j.jaad.2006.03.025. Epub 2006 May 26.'}]}, 'descriptionModule': {'briefSummary': 'A study of subjects with a known nickel allergy comparing Tacrolimus to placebo, both associated with nickel patches to determine the safety and efficacy of treating Chronic Allergic Contact Dermatitis with Tacrolimus Ointment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has a history of allergy to nickel\n\nExclusion Criteria:\n\n* Subject is pregnant or lactating\n* Subject fails to react to the nickel disks (grade 0), reacts with a questionable (grade 1) or extreme (grade 4) reaction or the subject's reactions on the left and right arms are not of the same grade of intensity\n* Subject has a known hypersensitivity to any component of the test medications\n* Subject has any other significant dermatological condition that affects \\>10% of the body surface area or general medical condition that could interfere with the study evaluation\n* Subject has any significant medical condition that could compromise immune responsiveness"}, 'identificationModule': {'nctId': 'NCT00667056', 'briefTitle': 'Study of the Safety and Efficacy of Tacrolimus Ointment in Treating Chronic Allergic Contact Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Trial to Assess the Safety and Efficacy of 0.1% Tacrolimus Ointment in the Treatment of Chronic Allergic Contact Dermatitis', 'orgStudyIdInfo': {'id': '20-04-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: tacrolimus ointment']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: placebo ointment']}], 'interventions': [{'name': 'tacrolimus ointment', 'type': 'DRUG', 'otherNames': ['Protopic', 'FK506 ointment'], 'description': 'topical', 'armGroupLabels': ['1']}, {'name': 'placebo ointment', 'type': 'DRUG', 'description': 'topical', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66216', 'city': 'Shawnee', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 39.04167, 'lon': -94.72024}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}], 'overallOfficials': [{'name': 'use central contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma US, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}