Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT01494467
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2011-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase 3 Papulopustular Rosacea Study
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': 'C010038', 'term': 'azelaic acid'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '609-409-7701', 'title': 'Clinical Science Director', 'organization': 'Galderma R&D, LLC'}, 'certainAgreement': {'otherDetails': 'At least sixty (60) days prior to submission for publication, presentation or use, the Institution and the Investigator shall submit in writing to the Contract Research Organization and Sponsor for review and comment any proposed oral or written publication, which period may be extended for an additional thirty (30) days if requested in writing by Contract Research Organization and Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.', 'description': 'Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).', 'eventGroups': [{'id': 'EG000', 'title': 'CD5024 1% Cream - Part A', 'description': 'Part A: CD5024 1% Cream, once daily application for 12 weeks', 'otherNumAtRisk': 458, 'otherNumAffected': 33, 'seriousNumAtRisk': 458, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'CD5024 Vehicle Cream - Part A', 'description': 'Part A: CD5024 Vehicle Cream, once daily application for 12 weeks', 'otherNumAtRisk': 230, 'otherNumAffected': 26, 'seriousNumAtRisk': 230, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'CD5024 1% Cream - Part B', 'description': 'Part B CD5024 1% Cream, once daily application for 40 weeks', 'otherNumAtRisk': 428, 'otherNumAffected': 102, 'seriousNumAtRisk': 428, 'seriousNumAffected': 13}, {'id': 'EG003', 'title': 'Azelaic Acid 15% Gel - Part B', 'description': 'Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks', 'otherNumAtRisk': 208, 'otherNumAffected': 47, 'seriousNumAtRisk': 208, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'CD5024 1% Cream - Part C', 'description': 'Part C: 4 week safety follow up. No drug applications', 'otherNumAtRisk': 353, 'otherNumAffected': 4, 'seriousNumAtRisk': 353, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C', 'description': 'Part C: 4 week safety follow up. No drug applications', 'otherNumAtRisk': 159, 'otherNumAffected': 3, 'seriousNumAtRisk': 159, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'CD5024 1% Cream - Overall', 'description': 'Overall number of subjects with adverse events for the entire duration of study', 'otherNumAtRisk': 460, 'otherNumAffected': 125, 'seriousNumAtRisk': 460, 'seriousNumAffected': 18}, {'id': 'EG007', 'title': 'CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall', 'description': 'Overall number of subjects with adverse events for the entire duration of study', 'otherNumAtRisk': 231, 'otherNumAffected': 64, 'seriousNumAtRisk': 231, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 52}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 48}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 30}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cholecystis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Colonic obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Postoperative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dysfunctional uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 460, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 231, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CD5024 1% Cream', 'description': 'CD5024 1% Cream, once daily application for 12 weeks'}, {'id': 'OG001', 'title': 'CD5024 Vehicle Cream', 'description': 'CD5024 Vehicle Cream, once daily application for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '40.1', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.\n\nEvaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:\n\nClear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF, ITT'}, {'type': 'PRIMARY', 'title': 'Absolute Change in Inflammatory Lesion Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CD5024 1% Cream', 'description': 'CD5024 1% Cream, once daily application for 12 weeks'}, {'id': 'OG001', 'title': 'CD5024 Vehicle Cream', 'description': 'CD5024 Vehicle Cream, once daily application for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.2', 'spread': '14.87', 'groupId': 'OG000'}, {'value': '-13.4', 'spread': '14.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.22', 'ciLowerLimit': '-10.18', 'ciUpperLimit': '-6.25', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).', 'unitOfMeasure': 'Lesion count change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF, ITT'}, {'type': 'SECONDARY', 'title': 'Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CD5024 1% Cream', 'description': 'CD5024 1% Cream, once daily application for 12 weeks'}, {'id': 'OG001', 'title': 'CD5024 Vehicle Cream', 'description': 'CD5024 Vehicle Cream, once daily application for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-65.7', 'spread': '33.18', 'groupId': 'OG000'}, {'value': '-43.4', 'spread': '38.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).', 'unitOfMeasure': 'Percentage of change in lesion counts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CD5024 1% Cream', 'description': 'Part A \\& B: CD5024 1% Cream, once daily application'}, {'id': 'FG001', 'title': 'CD5024 Vehicle Cream/Azelaic Acid 15% Gel', 'description': 'Part A: CD5024 Vehicle Cream, once daily application\n\nPart B: Azelaic acid 15% Gel, twice daily application'}], 'periods': [{'title': 'Part A Vehicle Control (12 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '459'}, {'groupId': 'FG001', 'numSubjects': '229'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '429'}, {'groupId': 'FG001', 'numSubjects': '208'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Part B Long Term Active Control 40 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '429 completed Part A. Subsequently, one subject discontinued so only 428 entered Part B', 'groupId': 'FG000', 'numSubjects': '428'}, {'groupId': 'FG001', 'numSubjects': '208'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '353'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '49'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Other (noted in eCRF)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Part C Safety Follow up (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '353'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '353'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '688', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CD5024 1% Cream', 'description': 'Part A: CD5024 1% Cream, once daily application for 12 weeks\n\nPart B: CD5024 1% Cream, once daily application for 40 weeks'}, {'id': 'BG001', 'title': 'CD5024 Vehicle Cream/Azelaic Acid 15% Gel', 'description': 'Part A: CD5024 Vehicle Cream, once daily application for 12 weeks\n\nPart B: Azelaic acid 15% Gel, twice daily application for 40 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'spread': '12.35', 'groupId': 'BG000'}, {'value': '49.5', 'spread': '12.16', 'groupId': 'BG001'}, {'value': '50.2', 'spread': '12.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '314', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '403', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '601', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', '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': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '438', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '656', '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': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Skin Photo Type', 'classes': [{'title': 'I', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'II', 'categories': [{'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}]}, {'title': 'III', 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}, {'title': 'IV', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}, {'title': 'V', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'VI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'DEFINITION OF SKIN PHOTOTYPE (T.B. Fitzpatrick):\n\nI: Always burns easily ; never tans II: Always burns easily ; tans minimally and with difficulty III: Burns minimally ; tans gradually and uniformly (light Brown) IV: Burns minimally ; always tans well (moderate brown) V: Rarely burns ; tans profusely (dark brown)) VI:Never burns ; deeply pigmented (black), tans profusely', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ITT population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 688}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'dispFirstSubmitDate': '2014-01-27', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2011-12-14', 'dispFirstSubmitQcDate': '2014-01-27', 'resultsFirstSubmitDate': '2015-01-08', 'studyFirstSubmitQcDate': '2011-12-15', 'dispFirstPostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-01-15', 'studyFirstPostDateStruct': {'date': '2011-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success Rate', 'timeFrame': 'Week 12', 'description': 'Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.\n\nEvaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:\n\nClear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)'}, {'measure': 'Absolute Change in Inflammatory Lesion Count', 'timeFrame': 'Baseline to Week 12', 'description': 'Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)', 'timeFrame': 'Baseline to Week 12', 'description': 'Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PPR'], 'conditions': ['Papulopustular Rosacea']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe),\n2. The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.\n\nExclusion Criteria:\n\n1. The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne,\n2. The subject has rosacea with more than two nodules on the face.'}, 'identificationModule': {'nctId': 'NCT01494467', 'briefTitle': 'Phase 3 Papulopustular Rosacea Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension Comparing the Long Term Safety of CD5024 1% Cream Versus Azelaic Acid 15 % Gel.', 'orgStudyIdInfo': {'id': 'RD.06.SPR.18171'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD5024', 'description': 'CD5024 1% Cream', 'interventionNames': ['Drug: CD5024']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CD5024 Vehicle', 'description': 'CD5024 Vehicle Cream', 'interventionNames': ['Drug: Azelaic acid 15% Gel']}], 'interventions': [{'name': 'CD5024', 'type': 'DRUG', 'description': 'CD5024 1% Cream, once daily', 'armGroupLabels': ['CD5024']}, {'name': 'Azelaic acid 15% Gel', 'type': 'DRUG', 'description': 'Topical Gel applied twice daily', 'armGroupLabels': ['CD5024 Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Total Skin and Beauty', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Coastal Clinical Research, Inc.', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Burke Pharmaceutical Research', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Specialists, Inc', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': 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