Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-28 @ 6:09 AM
Study NCT ID:
NCT00828568
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2009-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study of Two Imiquimod Cream 5%
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077271', 'term': 'Imiquimod'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medical.affairs@taro.com', 'phone': '(914) 345-9001', 'title': 'Medical Director', 'phoneExt': '6427', 'organization': 'Taro Pharmaceuticals USA'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Assessed at 24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Imiquimod 5% Taro', 'description': 'Imiquimod 5% manufactured by Taro applied for 16 weeks', 'otherNumAtRisk': 183, 'otherNumAffected': 22, 'seriousNumAtRisk': 183, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Aldara - Imiquimod 5%', 'description': 'Aldara, Imiquimod 5% applied for 16 weeks', 'otherNumAtRisk': 179, 'otherNumAffected': 22, 'seriousNumAtRisk': 179, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Vehicle', 'description': 'Patients receiving imiquimod Vehicle for 16 weeks', 'otherNumAtRisk': 60, 'otherNumAffected': 4, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'APPLICATION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'APPLICATION SITE IRRITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'APPLICATION SITE PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (11.1)'}], 'seriousEvents': [{'term': 'GASTROINTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'NEPHROLITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'LOBAR PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'CORONARY ARTERY OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'NECK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imiquimod 5% Taro', 'description': 'Imiquimod 5% manufactured by Taro applied for 16 weeks'}, {'id': 'OG001', 'title': 'Aldara - Imiquimod 5%', 'description': 'Aldara, Imiquimod 5% applied for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '4.85', 'ciLowerLimit': '-5.37', 'ciUpperLimit': '15.08', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "The 90% confidence limit around the difference in proportion of patients considered a Treatment Success between test and reference products was calculated using Blackwelder's method with Yate's continuity correction. If the 90% confidence interval for the test to reference ratio for the primary endpoint was within -0.20 to +0.20, then the test product would have been declared therapeutically equivalent to the reference product."}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Uses per protocol (PP) population.\n\nEach patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol (PP) population'}, {'type': 'SECONDARY', 'title': 'Patients Reporting at Least One Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Imiquimod 5% Taro', 'description': 'Imiquimod 5% manufactured by Taro applied for 16 weeks'}, {'id': 'OG001', 'title': 'Aldara - Imiquimod 5%', 'description': 'Aldara, Imiquimod 5% applied for 16 weeks'}, {'id': 'OG002', 'title': 'Vehicle', 'description': 'Patients receiving imiquimod vehicle for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'For all patients who received a single dose, adverse events were collected at each follow-up visit. Any patient reporting a single or multiple adverse events at any visit was conisdered to have had at least one adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety group includes all patients who received a single dose'}, {'type': 'PRIMARY', 'title': 'Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Imiquimod 5% Taro', 'description': 'Imiquimod 5% manufactured by Taro applied for 16 weeks'}, {'id': 'OG001', 'title': 'Aldara - Imiquimod 5%', 'description': 'Aldara, Imiquimod 5% applied for 16 weeks'}, {'id': 'OG002', 'title': 'Vehicle', 'description': 'Patients receiving imiquimod Vehicle for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Uses ITT population. Three patients (1 Imiquimod 5% Taro and 2 Imiquimod Aldara) did not have a follow-up visit after dosing and were excluded from ITT. Three patients (2 Imiquimod 5% Taro and 1 Imiquimod Aldara) were not evaluable at the 24-week visit and were not in the analysis.\n\nEach patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Imiquimod 5% Taro', 'description': 'Imiquimod 5% manufactured by Taro applied for 16 weeks'}, {'id': 'FG001', 'title': 'Aldara - Imiquimod 5%', 'description': 'Aldara, Imiquimod 5% applied for 16 weeks'}, {'id': 'FG002', 'title': 'Vehicle', 'description': 'Patients receiving imiquimod Vehicle for 16 weeks'}], 'periods': [{'title': 'Randomized', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '179'}, {'groupId': 'FG002', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '179'}, {'groupId': 'FG002', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Treated - Received at Least One Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '179'}, {'groupId': 'FG002', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '150'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Patients were recruited at 20 dermatology clinical practices.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '422', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Imiquimod 5% Taro', 'description': 'Imiquimod 5% manufactured by Taro applied for 16 weeks'}, {'id': 'BG001', 'title': 'Aldara - Imiquimod 5%', 'description': 'Aldara, Imiquimod 5% applied for 16 weeks'}, {'id': 'BG002', 'title': 'Vehicle', 'description': 'Patients receiving imiquimod Vehicle for 16 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '251', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '67.2', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '64.7', 'spread': '9.7', 'groupId': 'BG002'}, {'value': '67.2', 'spread': '9.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '347', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '422', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 425}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-21', 'studyFirstSubmitDate': '2009-01-22', 'resultsFirstSubmitDate': '2009-09-17', 'studyFirstSubmitQcDate': '2009-01-23', 'lastUpdatePostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-21', 'studyFirstPostDateStruct': {'date': '2009-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%', 'timeFrame': '24 weeks', 'description': 'Uses per protocol (PP) population.\n\nEach patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.'}, {'measure': 'Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline', 'timeFrame': '24 weeks', 'description': 'Uses ITT population. Three patients (1 Imiquimod 5% Taro and 2 Imiquimod Aldara) did not have a follow-up visit after dosing and were excluded from ITT. Three patients (2 Imiquimod 5% Taro and 1 Imiquimod Aldara) were not evaluable at the 24-week visit and were not in the analysis.\n\nEach patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.'}], 'secondaryOutcomes': [{'measure': 'Patients Reporting at Least One Adverse Event', 'timeFrame': '24 weeks', 'description': 'For all patients who received a single dose, adverse events were collected at each follow-up visit. Any patient reporting a single or multiple adverse events at any visit was conisdered to have had at least one adverse event.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Actinic Keratosis'], 'conditions': ['Actinic Keratosis']}, 'descriptionModule': {'briefSummary': 'The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK.\n\nThe secondary objective is to compare the adverse event (AE) profiles of the two creams.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment area on either the face or balding scalp\n* Women either must be 1 year post-menopausal, surgically sterile, or agree to use a medically accepted form or birth control\n* Free of any systemic or dermatological disorder\n* Any skin type or race, providing the skin pigmentation will allow discernment of erythema\n\nExclusion Criteria:\n\n* Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp)\n* History of cutaneous hyperreactivity or facial irritation to topical products\n* Engaging in activities involving excessive or prolonged exposure to sunlight\n* Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study entry\n* Currently using or have used systemic steroids 2 months prior to study\n* Currently using or have used on the treatment area over-the-counter retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic keratosis treatments 28 days prior to randomization\n* Pregnant or nursing mothers\n* History of allergy or sensitivity to imiquimod or related compounds or other components of the formulation\n* Taking immunosuppressant medication'}, 'identificationModule': {'nctId': 'NCT00828568', 'briefTitle': 'Bioequivalence Study of Two Imiquimod Cream 5%', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Two Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis', 'orgStudyIdInfo': {'id': 'MIQ-0403'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imiquimod 5% Taro', 'description': 'Imiquimod 5% manufactured by Taro applied for 16 weeks', 'interventionNames': ['Drug: Imiquimod 5% manufactured by Taro']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aldara - Imiquimod 5%', 'description': 'Aldara, Imiquimod 5% applied for 16 weeks', 'interventionNames': ['Drug: Aldara - Imiquimod 5%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Imiquimod vehicle applied for 16 weeks', 'interventionNames': ['Drug: Imiquimod Vehicle manufactured by Taro']}], 'interventions': [{'name': 'Imiquimod 5% manufactured by Taro', 'type': 'DRUG', 'description': 'Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks', 'armGroupLabels': ['Imiquimod 5% Taro']}, {'name': 'Aldara - Imiquimod 5%', 'type': 'DRUG', 'description': 'Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks', 'armGroupLabels': ['Aldara - Imiquimod 5%']}, {'name': 'Imiquimod Vehicle manufactured by Taro', 'type': 'DRUG', 'description': 'Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'city': 'Tuscon', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigator Site'}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Evansvill', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigator Site'}, {'city': 'Plainfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 39.70421, 'lon': -86.39944}}, {'city': 'Olathe', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 38.8814, 'lon': -94.81913}}, {'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Simpsonville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 34.73706, 'lon': -82.25428}}, {'city': 'Murfreesboro', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 35.84562, 'lon': -86.39027}}, {'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}