Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-03 @ 3:09 PM
Study NCT ID:
NCT02886702
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2016-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C086827', 'term': 'tazarotene'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'angela.kaplan@sandoz.com', 'phone': '631-659-2256', 'title': 'Angela C Kaplan', 'organization': 'Fougera Pharmaceuticals Inc.'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Fougera' agreements with its investigators may vary. However, Fougera does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days', 'eventGroups': [{'id': 'EG000', 'title': 'Test', 'description': 'Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)', 'otherNumAtRisk': 284, 'deathsNumAtRisk': 284, 'otherNumAffected': 31, 'seriousNumAtRisk': 284, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reference', 'description': 'TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)', 'otherNumAtRisk': 286, 'deathsNumAtRisk': 286, 'otherNumAffected': 24, 'seriousNumAtRisk': 286, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)', 'otherNumAtRisk': 285, 'deathsNumAtRisk': 285, 'otherNumAffected': 21, 'seriousNumAtRisk': 285, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Application site dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}, {'term': 'Application site erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}, {'term': 'Application site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}, {'term': 'Ischaemic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Success Assessed by IGA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)'}, {'id': 'OG001', 'title': 'Reference', 'description': 'TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)'}], 'classes': [{'categories': [{'measurements': [{'value': '60.8', 'groupId': 'OG000'}, {'value': '63.2', 'groupId': 'OG001'}, {'value': '56.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '90', 'paramValue': '-4.5', 'ciLowerLimit': '-12.6', 'ciUpperLimit': '3.6', 'pValueComment': 'p-value not calculated', 'statisticalMethod': "Yates' corrected confidence interval", 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '90% confidence interval on the difference between the proportions to be within \\[-20%, +20%\\].'}, {'pValue': '0.3520', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'stratified by clinical site', 'nonInferiorityComment': 'Last Observation Carried Forward (LOCF) for missing efficacy values'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator\'s Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT for superiority versus placebo, PP for equivalence versus Reference'}, {'type': 'SECONDARY', 'title': 'Disease Severity None or Minimal on IGA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)'}, {'id': 'OG001', 'title': 'Reference', 'description': 'TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000'}, {'value': '22.6', 'groupId': 'OG001'}, {'value': '16.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.8105', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'stratified by clinical site'}, {'pValue': '0.0613', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'stratified by clinical site'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)'}, {'id': 'OG001', 'title': 'Reference', 'description': 'TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}, {'value': '16.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'stratified by clinical site'}, {'pValue': '0.0712', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'stratified by clinical site'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test', 'description': 'Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)'}, {'id': 'FG001', 'title': 'Reference', 'description': 'TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized (Safety Population)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '286'}, {'groupId': 'FG002', 'numSubjects': '285'}]}, {'type': 'Modified Intent-to Treat (mITT)', 'comment': 'met all inclusion/exclusion criteria, received study treatment, and had a post-Baseline evaluation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '263'}, {'groupId': 'FG001', 'numSubjects': '266'}, {'groupId': 'FG002', 'numSubjects': '275'}]}, {'type': 'Per-Protocol Population (PP)', 'comment': 'all randomized subjects who complied with the protocol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '209'}, {'groupId': 'FG002', 'numSubjects': '201'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '235'}, {'groupId': 'FG002', 'numSubjects': '232'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'Significant Worsening of Condition', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Non-Compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Administrative Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'At Visit 1, eligible subjects were randomized to the Test, Reference or Placebo product in a 1:1:1 ratio using an interactive response technology (IRT) system.', 'preAssignmentDetails': '927 subjects were screened for study participation, 855 subjects were randomized and included in the statistical analyses.\n\n29 investigative sites (one with two locations) randomized subjects into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}, {'value': '855', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Test', 'description': 'Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)'}, {'id': 'BG001', 'title': 'Reference', 'description': 'TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'spread': '14.4', 'groupId': 'BG000'}, {'value': '53.7', 'spread': '14.2', 'groupId': 'BG001'}, {'value': '52.7', 'spread': '14.2', 'groupId': 'BG002'}, {'value': '53.3', 'spread': '14.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Started (Safety Population)'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '426', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '429', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Started (Safety Population)'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}, {'value': '514', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '341', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Started (Safety Population)'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-22', 'size': 826027, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-30T08:00', 'hasProtocol': True}, {'date': '2017-04-26', 'size': 832766, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-07-30T08:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 855}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-30', 'studyFirstSubmitDate': '2016-08-29', 'resultsFirstSubmitDate': '2018-07-30', 'studyFirstSubmitQcDate': '2016-08-29', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-30', 'studyFirstPostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Success Assessed by IGA', 'timeFrame': 'Week 12', 'description': 'Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator\'s Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study).'}], 'secondaryOutcomes': [{'measure': 'Disease Severity None or Minimal on IGA', 'timeFrame': 'Week 12', 'description': 'Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study).'}, {'measure': 'Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI', 'timeFrame': 'Week 12', 'description': 'Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a definite clinical diagnosis of stable (at least 6 months) plaque psoriasis, involving at least 2% and no more than 20% of the body surface area (BSA) (not including the scalp and intertriginous areas)\n* Have a minimum plaque elevation at the target lesion site of at least moderate severity (grade ≥ 3 on the Psoriasis Area Severity Index \\[PASI\\]). The most severe lesion at baseline should be identified as the target lesion\n* Have an Investigator's Global Assessment (IGA) of disease severity of at least moderate (score ≥ 3) as an overall assessment of all lesions to be treated.\n\nExclusion Criteria:\n\n* A female subject who is pregnant, nursing, planning a pregnancy, or does not agree to use an acceptable form of birth control within the study participation period\n* Have a current diagnosis of unstable forms of psoriasis in the treatment area, including pustular, guttate, exfoliative or erythrodermic psoriasis\n* Have a history of psoriasis unresponsive to topical treatments"}, 'identificationModule': {'nctId': 'NCT02886702', 'briefTitle': 'A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fougera Pharmaceuticals Inc.'}, 'officialTitle': 'A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis', 'orgStudyIdInfo': {'id': '0453-01-01'}, 'secondaryIdInfos': [{'id': '0453', 'type': 'OTHER', 'domain': 'Fougera Pharmaceuticals Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': 'Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)', 'interventionNames': ['Drug: Tazarotene Cream 0.05%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference', 'description': 'TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)', 'interventionNames': ['Drug: TAZORAC® (tazarotene) Cream 0.05%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tazarotene Cream 0.05%', 'type': 'DRUG', 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