Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT00475605
Status:
TERMINATED
Last Update Posted:
2019-12-18
First Post:
2007-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8071}}, 'statusModule': {'whyStopped': 'Terminated early, endorsed by the FDA based on futility of continuation.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-16', 'studyFirstSubmitDate': '2007-05-17', 'studyFirstSubmitQcDate': '2007-05-17', 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of systemic or cutaneous malignancy', 'timeFrame': '10 years', 'description': 'Standardised Incidence Ratio (versus population cancer rates)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atopic dermatitis', 'child', 'tacrolimus ointment', 'Protopic Ointment'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'D3T01.1J No increased risk of cancer in children using topical tacrolimus for atopic dermatitis: A 10-year prospective cohort study Prof. Dr. Regina Fölster-Holst - Germany 12 October 2019 11:00 - 11:15 EADV 2019'}]}, 'descriptionModule': {'briefSummary': 'This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were \\< 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.', 'detailedDescription': 'Data will be collected at enrollment and every 6 months thereafter either by interview, Internet, or physician office visit. Each subject will be followed for 10 years in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric subjects whose ages are/were \\<16 years at the time of first tacrolimus ointment exposure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who first used Protopic® 0.03% or 0.1% before they were sixteen years of age and were treated for at least 6 weeks for the treatment of Atopic dermatitis may enroll into the study.'}, 'identificationModule': {'nctId': 'NCT00475605', 'acronym': 'APPLES', 'briefTitle': 'A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'F506-CL-5801'}, 'secondaryIdInfos': [{'id': 'FG506-06-37', 'type': 'OTHER', 'domain': 'Sponsor'}, {'id': '03-0-161', 'type': 'OTHER', 'domain': 'Sponsor (Astellas)'}, {'id': 'EUPAS', 'type': 'REGISTRY', 'domain': 'EUPAS12360'}, {'id': 'LP0156-1294', 'type': 'OTHER', 'domain': 'Sponsor (LEO Pharma A/S)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1. Protopic Exposure', 'description': 'Pediatric subjects whose ages are/were \\<16 years at the time of first tacrolimus ointment exposure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35007', 'city': 'Alabaster', 'state': 'Alabama', 'country': 'United States', 'facility': 'Shelby Dermatology', 'geoPoint': {'lat': 33.24428, 'lon': -86.81638}}, {'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pediatric Care Center of NE Alabama', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Total Skin and Beauty Dermatology Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Metro Pediatrics, P.C', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pediatric & Adult Asthma and Allergy, P.C.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Skin Wellness Center of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35213', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southview Dermatology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Ruth A Yates', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Alliance Dermatology', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85048', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Derma', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Burke Pharmaceutical Research', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Hull Dermatology, P.A.', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '93010', 'city': 'Camarillo', 'state': 'California', 'country': 'United States', 'facility': 'Coastal Allergy Care', 'geoPoint': {'lat': 34.21639, 'lon': -119.0376}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Tien Nguyen', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'California Skin Institute', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Capital Allergy & Respiratory Disease Center', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '92111', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Allergy and Immunology Clinic', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94583', 'city': 'San Ramon', 'state': 'California', 'country': 'United States', 'facility': 'California Dermatology Care', 'geoPoint': {'lat': 37.77993, 'lon': -121.97802}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center Dept of Dermatology", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '19707', 'city': 'Hockessin', 'state': 'Delaware', 'country': 'United States', 'facility': 'Webster Dermatology, PA', 'geoPoint': {'lat': 39.78761, 'lon': -75.6966}}, {'zip': '19810', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Atlantic Skin & Cosmetic Surgery Group', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '33428', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Dermatology', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Angelos Koutsonikolis, MD, PA', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Joshua Berlin P.A.', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Fort Lauderdale Dermatology & Cosmetic Skin Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'North Florida Dermatology Associates, P.A.', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33181', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Andrea Trowers, MD', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '33162', 'city': 'North Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Tory Patrick Sullivan', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'zip': '33408', 'city': 'North Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Allergy Associates of the Palm Beaches, PA', 'geoPoint': {'lat': 26.81756, 'lon': -80.08199}}, {'zip': '32819', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Dermatology', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33418', 'city': 'Palm Beach Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Donna Zeide', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Waterman Dermatology', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '33615', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Olympian Clinical Research', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33626', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Dr.Robert A. Norman', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31707', 'city': 'Albany', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Pollens Clinical Research Centers, Inc', 'geoPoint': {'lat': 31.57851, 'lon': -84.15574}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30014', 'city': 'Covington', 'state': 'Georgia', 'country': 'United States', 'facility': 'Dermatology Consultants PC', 'geoPoint': {'lat': 33.59678, 'lon': -83.86018}}, {'zip': '31217', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Dermatologic Surgery Specialist Inc.', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '30263', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'facility': 'MedaPhase,Inc.', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'AeroAllergy Research Labs of Savannah, Inc.', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southern Crescent Dermatology', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '96701', 'city': '‘Aiea', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Paul S. Takiguchi- MD- Inc.', 'geoPoint': {'lat': 21.38222, 'lon': -157.93361}}, {'zip': '96701', 'city': '‘Aiea', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Wayne Fujita, M.D. - Private Practice', 'geoPoint': {'lat': 21.38222, 'lon': -157.93361}}, {'zip': '83704', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Dermatology Clinic of Idaho', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Southeast Idaho Family Practice', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '62226', 'city': 'Belleville', 'state': 'Illinois', 'country': 'United States', 'facility': 'DermAssociates LTD', 'geoPoint': {'lat': 38.52005, 'lon': -89.98399}}, {'zip': '61820', 'city': 'Champaign', 'state': 'Illinois', 'country': 'United States', 'facility': 'Christie Clinic', 'geoPoint': {'lat': 40.11642, 'lon': -88.24338}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Memorial Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dermatology, Inc.', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Shideler Clinical Research Center', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '46240', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dermatology Associates, PC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin Clinical Research Group, LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '47150', 'city': 'New Albany', 'state': 'Indiana', 'country': 'United States', 'facility': 'The Dermatology Center', 'geoPoint': {'lat': 38.28562, 'lon': -85.82413}}, {'zip': '46168', 'city': 'Plainfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dermatology Center of Indiana P.C.', 'geoPoint': {'lat': 39.70421, 'lon': -86.39944}}, {'zip': '47906', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Randall Dermatology', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}, {'zip': '52732', 'city': 'Clinton', 'state': 'Iowa', 'country': 'United States', 'facility': 'Clinton Urgent Care', 'geoPoint': {'lat': 41.84447, 'lon': -90.18874}}, {'zip': '66209', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Midwest Dermatology', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66215', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas City Dermatology, PA', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66614', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas Medical Clinic, PA', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '67206', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Mid-Kansas Dermatology Clinic, PA', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40701', 'city': 'Corbin', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Melissa Knuckles', 'geoPoint': {'lat': 36.9487, 'lon': -84.09688}}, {'zip': '40356', 'city': 'Nicholasville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Michael W. 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