Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-27 @ 4:58 AM
Study NCT ID:
NCT01139450
Status:
COMPLETED
Last Update Posted:
2014-10-09
First Post:
2010-06-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of 0417 Ointment in the Treatment of Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723274', 'term': 'SIM0417'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'angela.kaplan@sandoz.com', 'phone': '631-659-2256', 'title': 'Angela C. Kaplan', 'organization': 'Fougera Pharmaceuticals Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Test', 'description': 'Test product that contains the active pharmaceutical ingredient\n\nTacrolimus Ointment 0.03% test product applied twice daily for 4 weeks', 'otherNumAtRisk': 302, 'otherNumAffected': 17, 'seriousNumAtRisk': 302, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Reference', 'description': 'Reference product that contains the active pharmaceutical ingredient\n\nProtopic Ointment 0.03%, Reference product applied twice daily for 4 weeks', 'otherNumAtRisk': 297, 'otherNumAffected': 12, 'seriousNumAtRisk': 297, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Vehicle', 'description': 'Placebo that contains no active pharmaceutical ingredient\n\nVehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks', 'otherNumAtRisk': 300, 'otherNumAffected': 20, 'seriousNumAtRisk': 300, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Application site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 8}], 'organSystem': 'General disorders'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Moderate Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Severe Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Test product that contains the active pharmaceutical ingredient\n\nTacrolimus Ointment 0.03% test product applied twice daily for 4 weeks'}, {'id': 'OG001', 'title': 'Reference', 'description': 'Reference product that contains the active pharmaceutical ingredient\n\nProtopic Ointment 0.03%, Reference product applied twice daily for 4 weeks'}, {'id': 'OG002', 'title': 'Vehicle', 'description': 'Placebo that contains no active pharmaceutical ingredient\n\nVehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'unitOfMeasure': 'participants'}, {'type': 'SECONDARY', 'title': 'The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region', 'timeFrame': 'Baseline, 4 weeks'}, {'type': 'SECONDARY', 'title': 'The Mean Change From Baseline in Pruritus', 'timeFrame': 'Baseline, 4 weeks'}, {'type': 'SECONDARY', 'title': 'The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA)', 'timeFrame': 'Baseline, 4 weeks'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test', 'description': 'Test product that contains the active pharmaceutical ingredient\n\nTacrolimus Ointment 0.03% test product applied twice daily for 4 weeks'}, {'id': 'FG001', 'title': 'Reference', 'description': 'Reference product that contains the active pharmaceutical ingredient\n\nProtopic Ointment 0.03%, Reference product applied twice daily for 4 weeks'}, {'id': 'FG002', 'title': 'Vehicle', 'description': 'Placebo that contains no active pharmaceutical ingredient\n\nVehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '302'}, {'groupId': 'FG001', 'numSubjects': '297'}, {'groupId': 'FG002', 'numSubjects': '300'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '272'}, {'groupId': 'FG002', 'numSubjects': '262'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'BG000'}, {'value': '297', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}, {'value': '899', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Test', 'description': 'Test product that contains the active pharmaceutical ingredient\n\nTacrolimus Ointment 0.03% test product applied twice daily for 4 weeks'}, {'id': 'BG001', 'title': 'Reference', 'description': 'Reference product that contains the active pharmaceutical ingredient\n\nProtopic Ointment 0.03%, Reference product applied twice daily for 4 weeks'}, {'id': 'BG002', 'title': 'Vehicle', 'description': 'Placebo that contains no active pharmaceutical ingredient\n\nVehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age, Years', 'categories': [{'measurements': [{'value': '27.74', 'spread': '18.11', 'groupId': 'BG000'}, {'value': '28.8', 'spread': '18.99', 'groupId': 'BG001'}, {'value': '27.6', 'spread': '17.34', 'groupId': 'BG002'}, {'value': '28.0', 'spread': '18.14', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}, {'value': '566', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '333', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '280', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '834', 'groupId': 'BG003'}]}]}, {'title': 'Central America', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 899}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'dispFirstSubmitDate': '2014-06-16', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-30', 'studyFirstSubmitDate': '2010-06-07', 'dispFirstSubmitQcDate': '2014-06-16', 'resultsFirstSubmitDate': '2014-09-23', 'studyFirstSubmitQcDate': '2010-06-07', 'dispFirstPostDateStruct': {'date': '2014-06-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-29', 'studyFirstPostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment", 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region', 'timeFrame': 'Baseline, 4 weeks'}, {'measure': 'The Mean Change From Baseline in Pruritus', 'timeFrame': 'Baseline, 4 weeks'}, {'measure': 'The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA)', 'timeFrame': 'Baseline, 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atopic Dermatitis'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to assess the efficacy of 0417 Ointment in the Treatment of Atopic Dermatitis.\n\nTreatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Atopic Dermatitis\n* Good health with the exception of Atopic Dermatitis\n* Percent Body Surface Area minimum requirements\n\nExclusion Criteria:\n\n* Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.\n* Subjects who have any systemic or dermatological disorders with the exception of Atopic Dermatitis'}, 'identificationModule': {'nctId': 'NCT01139450', 'briefTitle': 'Study of 0417 Ointment in the Treatment of Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fougera Pharmaceuticals Inc.'}, 'officialTitle': 'Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0417 Ointment', 'orgStudyIdInfo': {'id': '0417'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': 'Test product that contains the active pharmaceutical ingredient', 'interventionNames': ['Drug: 0417']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference', 'description': 'Reference product that contains the active pharmaceutical ingredient', 'interventionNames': ['Drug: Tacrolimus Ointment 0.03%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Placebo that contains no active pharmaceutical ingredient', 'interventionNames': ['Drug: Vehicle of 0417 test product']}], 'interventions': [{'name': '0417', 'type': 'DRUG', 'description': 'Topical 0417 test product applied twice daily for 4 weeks', 'armGroupLabels': ['Test']}, {'name': 'Vehicle of 0417 test product', 'type': 'DRUG', 'description': 'Vehicle of 0417 test product applied twice daily for 4 weeks', 'armGroupLabels': ['Vehicle']}, {'name': 'Tacrolimus Ointment 0.03%', 'type': 'DRUG', 'description': 'Reference product for 0417 test product. Apply twice daily for 4 weeks', 'armGroupLabels': ['Reference']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11747', 'city': 'Melville', 'state': 'New York', 'country': 'United States', 'facility': 'Fougera Pharmaceuticals Inc.', 'geoPoint': {'lat': 40.79343, 'lon': -73.41512}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fougera Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}