Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT01871402
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2013-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -304)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalresearch@therapeuticsinc.com', 'phone': '858-571-1800', 'title': 'Clinical Research, Therapeutics, Inc.', 'organization': 'Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': 'The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 12 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 30 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.', 'description': 'The Safety population included all subjects enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=221) were included in the safety population. Most AEs were mild in severity.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Arm', 'description': 'Topical lotion, applied twice daily\n\n000-0551 Lotion', 'otherNumAtRisk': 110, 'otherNumAffected': 2, 'seriousNumAtRisk': 110, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle Arm', 'description': 'Topical lotion, applied twice daily\n\nVehicle Lotion', 'otherNumAtRisk': 111, 'otherNumAffected': 7, 'seriousNumAtRisk': 111, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects Rated a "Treatment Success" Based on the Investigator\'s Global Assessment (IGA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Topical lotion, applied twice daily\n\n000-0551 Lotion'}, {'id': 'OG001', 'title': 'Vehicle Arm', 'description': 'Topical lotion, applied twice daily\n\nVehicle Lotion'}], 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Treatment groups were compared with respect to the proportions of subjects with "treatment success" at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Multiple imputation was used to impute missing data from the ITT population.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', 'description': 'The IGA score is a static evaluation of the overall or "average" degree of severity of a subject\'s disease, taking into account all of the subject\'s psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis shown is based on the Intent-to-Treat population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Topical lotion, applied twice daily\n\n000-0551 Lotion'}, {'id': 'OG001', 'title': 'Vehicle Arm', 'description': 'Topical lotion, applied twice daily\n\nVehicle Lotion'}], 'classes': [{'title': 'Scaling', 'categories': [{'measurements': [{'value': '55.5', 'groupId': 'OG000'}, {'value': '10.8', 'groupId': 'OG001'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}, {'value': '7.2', 'groupId': 'OG001'}]}]}, {'title': 'Plaque Elevation', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '8.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistical significance (\\<0.001) was achieved for each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).', 'groupDescription': 'Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data was imputed as treatment failure.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', 'description': 'A static assessment of the overall or "average" degree of severity of each of three key characteristics present within all of the subject\'s psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis shown is based on the ITT population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Subjects With IGA "Treatment Success" at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Topical lotion, applied twice daily\n\n000-0551 Lotion'}, {'id': 'OG001', 'title': 'Vehicle Arm', 'description': 'Topical lotion, applied twice daily\n\nVehicle Lotion'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8', 'description': 'Interim analysis of IGA. "Treatment success" and IGA as defined in the primary outcome measure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis shown is based on the ITT population. Only participants with observed values are reported.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Topical lotion, applied twice daily\n\n000-0551 Lotion'}, {'id': 'OG001', 'title': 'Vehicle Arm', 'description': 'Topical lotion, applied twice daily\n\nVehicle Lotion'}], 'classes': [{'title': 'Scaling', 'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Plaque Elevation', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistical significance (\\<0.001) was achieved for each of the clinical signs of psoriasis (scaling, erythema, and plaque elevations).', 'groupDescription': 'Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8', 'description': 'Interim analysis of clinical signs of psoriasis (scaling, erythema and plaque elevation). "Treatment success" and clinical signs as defined in the secondary outcome measure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis shown is based on the ITT population. Only participants with observed values are reported.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Pruritus Score at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Topical lotion, applied twice daily\n\n000-0551 Lotion'}, {'id': 'OG001', 'title': 'Vehicle Arm', 'description': 'Topical lotion, applied twice daily\n\nVehicle Lotion'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.2', 'spread': '3.46', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '3.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 15', 'description': "Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis shown is based on the ITT population. Only participants with observed values are reported.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in % Body Surface Area (BSA) With Active Psoriasis at Days 8 and 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Topical lotion, applied twice daily\n\n000-0551 Lotion'}, {'id': 'OG001', 'title': 'Vehicle Arm', 'description': 'Topical lotion, applied twice daily\n\nVehicle Lotion'}], 'classes': [{'title': 'Day 8', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8 and Day 15', 'description': "The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.", 'unitOfMeasure': 'Change in %BSA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis shown is based on the ITT population at Days 8 and 15 and compared to baseline. Number of Participants Analyzed is at Day 15; at Day 8, N=109 (Active) and N=110 (Vehicle). Only participants with observed values are reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Arm', 'description': 'Topical lotion, applied twice daily\n\n000-0551 Lotion'}, {'id': 'FG001', 'title': 'Vehicle Arm', 'description': 'Topical lotion, applied twice daily\n\nVehicle Lotion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment period: May 2013 to December 2013\n\nThe location of clinical sites included dermatology clinics and clinical research centers.', 'preAssignmentDetails': 'All subjects who met the entry criteria were randomized and enrolled into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Arm', 'description': 'Topical lotion, applied twice daily\n\n000-0551 Lotion'}, {'id': 'BG001', 'title': 'Vehicle Arm', 'description': 'Topical lotion, applied twice daily\n\nVehicle Lotion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.9', 'spread': '12.28', 'groupId': 'BG000'}, {'value': '50.8', 'spread': '14.15', 'groupId': 'BG001'}, {'value': '51.8', 'spread': '13.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2015-02-13', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-11', 'studyFirstSubmitDate': '2013-06-04', 'dispFirstSubmitQcDate': '2015-02-13', 'resultsFirstSubmitDate': '2016-03-10', 'studyFirstSubmitQcDate': '2013-06-04', 'dispFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-10', 'studyFirstPostDateStruct': {'date': '2013-06-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion of Subjects With IGA "Treatment Success" at Day 8', 'timeFrame': 'Day 8', 'description': 'Interim analysis of IGA. "Treatment success" and IGA as defined in the primary outcome measure.'}, {'measure': 'Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis at Day 8', 'timeFrame': 'Day 8', 'description': 'Interim analysis of clinical signs of psoriasis (scaling, erythema and plaque elevation). "Treatment success" and clinical signs as defined in the secondary outcome measure.'}, {'measure': 'Change From Baseline in Pruritus Score at Day 15', 'timeFrame': 'Baseline and Day 15', 'description': "Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus)."}, {'measure': 'Change in % Body Surface Area (BSA) With Active Psoriasis at Days 8 and 15', 'timeFrame': 'Baseline, Day 8 and Day 15', 'description': "The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area."}], 'primaryOutcomes': [{'measure': 'Proportion of Subjects Rated a "Treatment Success" Based on the Investigator\'s Global Assessment (IGA)', 'timeFrame': 'Day 15', 'description': 'The IGA score is a static evaluation of the overall or "average" degree of severity of a subject\'s disease, taking into account all of the subject\'s psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)', 'timeFrame': 'Day 15', 'description': 'A static assessment of the overall or "average" degree of severity of each of three key characteristics present within all of the subject\'s psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['psoriasis', 'lotion', "investigator's global assessment"], 'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'This Phase 3 study has been designed to determine and compare the efficacy and safety of 000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% affected body surface area.\n* Subject has an Investigator's Global Assessment (IGA) score of at least three (moderate) at study start.\n* If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study.\n\nExclusion Criteria:\n\n* Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.\n* Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.\n* Subject has used any phototherapy (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to study start.\n* Subject has used any systemic methotrexate, retinoids, systemic corticosteroids \\[including intralesional, intra-articular, and intramuscular corticosteroids\\], cyclosporine or analogous products within 90 days prior to study start.\n* Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental therapy) within five half-lives of the biologic prior to study start.\n* Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start or is intending to have such exposure during the study.\n* Subject has used topical body (excluding the scalp) psoriasis therapy (including coal tar, anthralin, steroids, retinoids, vitamin D analogs) within 14 days prior to study start.\n* Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at study start.\n* Subject is currently using lithium or Plaquenil (hydroxychloroquine).\n* Subject is currently using a beta-blocking medication (e.g., propanolol) or angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized.\n* Subject is pregnant, lactating, or is planning to become pregnant during the study.\n* Subject is currently enrolled in an investigational drug or device study.\n* Subject has used an investigational drug or investigational device treatment within 30 days prior to study start.\n* Subject has been previously enrolled in this study and treated with a test article."}, 'identificationModule': {'nctId': 'NCT01871402', 'briefTitle': 'A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -304)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Therapeutics, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -304)', 'orgStudyIdInfo': {'id': '000-0551-304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Arm', 'description': 'Topical lotion, applied twice daily', 'interventionNames': ['Drug: 000-0551 Lotion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Arm', 'description': 'Topical lotion, applied twice daily', 'interventionNames': ['Drug: Vehicle Lotion']}], 'interventions': [{'name': '000-0551 Lotion', 'type': 'DRUG', 'armGroupLabels': ['Active Arm']}, {'name': 'Vehicle Lotion', 'type': 'DRUG', 'armGroupLabels': ['Vehicle Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Center for Dermatology Clinical Research, Inc.', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Dermatology', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Altman Dermatology Associates', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Clinical Study Center', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wilmington Dermatology Center', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Medical Research Center, PC', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Johnston', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Clinical Partners, LLC', 'geoPoint': {'lat': 41.82186, 'lon': -71.50675}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Across America', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Clinical Research, Inc.', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Syd Dromgoole, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}