Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-02 @ 4:06 AM
Study NCT ID:
NCT02576860
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2015-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625752', 'term': 'Omiganan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ctinfo@mii.maruho.co.jp', 'phone': '+81-75-325-3255', 'title': 'Maruho Co.,Ltd. Kyoto R&D Center', 'organization': 'Clinical Development Dept.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '115 Days', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'CLS001 (Omignan) gel applied once daily\n\nCLS001 (Omiganan): Topical gel', 'otherNumAtRisk': 136, 'deathsNumAtRisk': 136, 'otherNumAffected': 47, 'seriousNumAtRisk': 136, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel applied once daily\n\nVehicle: Vehicle gel', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 36, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20'}], 'seriousEvents': [{'term': 'Salmonellosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy Absolute Change in Inflammatory Lesion Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'CLS001 (Omignan) gel applied once daily\n\nCLS001 (Omiganan): Topical gel'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel applied once daily\n\nVehicle: Vehicle gel'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.8', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '-20.9', 'spread': '2.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.799', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'Absolute change in inflammatory lesion count from baseline to Week 12.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The 'Intent-to-treat' (ITT) analysis population included all randomized subjects."}, {'type': 'PRIMARY', 'title': 'Efficacy IGA: 2 Grade Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'CLS001 (Omignan) gel applied once daily\n\nCLS001 (Omiganan): Topical gel'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel applied once daily\n\nVehicle: Vehicle gel'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '25.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.858', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).', 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': "The 'Intent-to-treat' (ITT) analysis population included all randomized subjects."}, {'type': 'SECONDARY', 'title': 'Efficacy The Absolute Change in Inflammatory Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'CLS001 (Omignan) gel applied once daily\n\nCLS001 (Omiganan): Topical gel'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel applied once daily\n\nVehicle: Vehicle gel'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.6', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '-20.9', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '9 weeks', 'description': 'The absolute change in inflammatory lesions from baseline to Week 9.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The 'Intent-to-treat' (ITT) analysis population included all randomized subjects."}, {'type': 'SECONDARY', 'title': 'Efficacy The Absolute Change in Inflammatory Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'CLS001 (Omignan) gel applied once daily\n\nCLS001 (Omiganan): Topical gel'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel applied once daily\n\nVehicle: Vehicle gel'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.2', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '-19.8', 'spread': '2.06', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'The absolute change in inflammatory lesions from baseline to Week 6.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The 'Intent-to-treat' (ITT) analysis population included all randomized subjects."}, {'type': 'SECONDARY', 'title': 'Efficacy IGA: 2 Point Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'CLS001 (Omignan) gel applied once daily\n\nCLS001 (Omiganan): Topical gel'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel applied once daily\n\nVehicle: Vehicle gel'}], 'classes': [{'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000'}, {'value': '21.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 Weeks', 'description': 'Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).', 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': "The 'Intent-to-treat' (ITT) analysis population included all randomized subjects."}, {'type': 'SECONDARY', 'title': 'Efficacy IGA: 2 Point Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'CLS001 (Omignan) gel applied once daily\n\nCLS001 (Omiganan): Topical gel'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel applied once daily\n\nVehicle: Vehicle gel'}], 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}, {'value': '15.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Weeks', 'description': 'Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).', 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': "The 'Intent-to-treat' (ITT) analysis population included all randomized subjects."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CLS001 (Omignan) Gel', 'description': 'CLS001 (Omignan) gel applied once daily\n\nCLS001 (Omiganan): Topical gel'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel applied once daily\n\nVehicle: Vehicle gel'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Subjects with 1 or more treatment-related Treatment-Emergent Adverse Events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The 'Intent-to-treat' (ITT) analysis population included all randomized subjects."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'CLS001 (Omignan) gel applied once daily\n\nCLS001 (Omiganan): Topical gel'}, {'id': 'FG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel applied once daily\n\nVehicle: Vehicle gel'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Disallowed medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 42 sites in the USA, Canada, Australia/New Zealand, and durope from December 2015 to February 2017.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'CLS001 (Omignan) gel applied once daily\n\nCLS001 (Omiganan): Topical gel'}, {'id': 'BG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel applied once daily\n\nVehicle: Vehicle gel'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'spread': '14.06', 'groupId': 'BG000'}, {'value': '52.4', 'spread': '13.66', 'groupId': 'BG001'}, {'value': '51.8', 'spread': '13.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '228', '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': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total Inflammatory Lesion Count', 'classes': [{'categories': [{'measurements': [{'value': '53.1', 'spread': '24.78', 'groupId': 'BG000'}, {'value': '51.0', 'spread': '19.42', 'groupId': 'BG001'}, {'value': '52.1', 'spread': '22.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Defined as the total number of papules and pustules.', 'unitOfMeasure': 'lesion count', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': "The 'Intent-to-treat' (ITT) analysis population included all randomized subjects."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-10', 'size': 2266788, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-13T01:27', 'hasProtocol': True}, {'date': '2017-03-07', 'size': 575127, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-13T01:28', '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': 263}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'dispFirstSubmitDate': '2018-02-27', 'completionDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-07', 'studyFirstSubmitDate': '2015-10-13', 'dispFirstSubmitQcDate': '2018-02-27', 'resultsFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2015-10-13', 'dispFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-13', 'studyFirstPostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety Adverse Events', 'timeFrame': '12 weeks', 'description': 'Subjects with 1 or more treatment-related Treatment-Emergent Adverse Events'}], 'primaryOutcomes': [{'measure': 'Efficacy Absolute Change in Inflammatory Lesion Count', 'timeFrame': '12 weeks', 'description': 'Absolute change in inflammatory lesion count from baseline to Week 12.'}, {'measure': 'Efficacy IGA: 2 Grade Reduction', 'timeFrame': '12 weeks', 'description': 'Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).'}], 'secondaryOutcomes': [{'measure': 'Efficacy The Absolute Change in Inflammatory Lesions', 'timeFrame': '9 weeks', 'description': 'The absolute change in inflammatory lesions from baseline to Week 9.'}, {'measure': 'Efficacy The Absolute Change in Inflammatory Lesions', 'timeFrame': '6 weeks', 'description': 'The absolute change in inflammatory lesions from baseline to Week 6.'}, {'measure': 'Efficacy IGA: 2 Point Reduction', 'timeFrame': '9 Weeks', 'description': 'Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).'}, {'measure': 'Efficacy IGA: 2 Point Reduction', 'timeFrame': '6 Weeks', 'description': 'Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rosacea']}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy, male and non-pregnant female subjects, 18 years of age or older.\n2. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.\n3. Subjects with the presence of telangiectasia at Baseline.\n4. Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline.\n5. Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.\n\nExclusion Criteria:\n\n1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).\n2. Subjects with nodular rosacea.\n3. 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