Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-12 @ 3:15 AM
Study NCT ID:
NCT02798120
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2016-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
P3 Long Term Safety Study of Once Daily SB204 in Acne
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000709171', 'term': 'berdazimer sodium'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical@novan.com', 'phone': '9194858080', 'title': 'Cathy White, Vice President, Drug Development Operations', 'organization': 'Novan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline through Week 40 (approximately 9 months)', 'description': 'Treatment emergent adverse events (TEAEs) were defined as AEs reported on or after the first day of enrollment in this long term safety study. They are reported for the combined study safety population (SB204 experienced + SB204 naive).', 'eventGroups': [{'id': 'EG000', 'title': 'SB204 Experienced', 'description': 'Subjects who received SB204 4% QD in the parent study (NI-AC301 or NI-AC302) and continued to receive open label SB204 4% QD in this study.', 'otherNumAtRisk': 296, 'deathsNumAtRisk': 296, 'otherNumAffected': 34, 'seriousNumAtRisk': 296, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'SB204 Naive', 'description': 'Subjects who received vehicle gel QD in the parent study (NI-AC301 or NI-AC302) and SB204 4% QD in this study.', 'otherNumAtRisk': 305, 'deathsNumAtRisk': 305, 'otherNumAffected': 32, 'seriousNumAtRisk': 305, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 305, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 305, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Application site dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 305, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 305, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 305, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 305, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 305, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conduct Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SB204 Experienced', 'description': 'Subjects who were assigned to the SB204 4% QD treatment group in NI-AC301/NI-AC302.'}, {'id': 'OG001', 'title': 'SB204 Naive', 'description': 'Subjects who were assigned to the Vehicle Gel QD treatment group in NI-AC301/NI-AC302.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'This outcome measure shows the number of subjects with at least one ongoing adverse event from the pivotal studies (NI-AC301 and NI-AC302) at the time they rolled over into this study (NI-AC303). The final study visit (Week 12) for the pivotal studies served as the Baseline visit for this study. Subjects who were assigned to SB204 in the pivotal studies are denoted as SB204 Experienced and subjects who were assigned to Vehicle Gel on the pivotal studies are denoted as SB204 Naive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population There were 59 subjects in the SB204 Experienced group with 104 ongoing AEs at the time of rollover and 62 SB204 Naive subjects with 97 ongoing AEs at the time of rollover.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SB204 Experienced', 'description': 'Subjects who were assigned to and received SB204 4% QD in the parent (pivotal) study (NI-AC301 or NI-AC302).'}, {'id': 'OG001', 'title': 'SB204 Naive', 'description': 'Subjects who were assigned to and received Vehicle Gel in the parent (pivotal) study (NI-AC301 or NI-AC302).'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 40/End of Treatment', 'description': 'Number of subjects with adverse events that had an onset date on or after entry into study NI-AC303.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '601', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SB204 4%', 'description': 'SB204 4%: Open label, topical SB204 4% once daily.'}], 'classes': [{'title': 'Baseline: Erythema: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '493', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Erythema: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Erythema: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Erythema: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Erythema: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '461', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Erythema: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Erythema: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Erythema: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Erythema: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '432', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Erythema: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Erythema: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Erythema: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Erythema: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '411', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Erythema: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Erythema: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Erythema: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Erythema: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '385', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Erythema: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Erythema: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Erythema: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Erythema: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '387', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Erythema: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Erythema: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Erythema: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Erythema: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '419', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET Erythema: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Erythema: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Erythema: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Scaling: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '553', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Scaling: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Scaling: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Scaling: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Scaling: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '535', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Scaling: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Scaling: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Scaling: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Scaling: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '487', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Scaling: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Scaling: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Scaling: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Scaling: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '449', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Scaling: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Scaling: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Scaling: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Scaling: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '398', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Scaling: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Scaling: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Scaling: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Scaling: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '423', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Scaling: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Scaling: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Scaling: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Scaling: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '462', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Scaling: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Scaling: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Scaling: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Dryness: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '510', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Dryness: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Dryness: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Dryness: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Dryness: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '496', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Dryness: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Dryness: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Dryness: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Dryness: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '440', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Dryness: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Dryness: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Dryness: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Dryness: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '398', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Dryness: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Dryness: moderate (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Dryness: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Dryness: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '382', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Dryness: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Dryness: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Dryness: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Dryness: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '386', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Dryness: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Dryness: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Dryness: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Dryness: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '422', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET Dryness: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Dryness: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET Week 40/ET: Dryness: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Pruritus: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '560', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Pruritus: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Pruritus: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Pruritus: severe (3) Baseline: Pruritus: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Pruritus: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '540', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Pruritus: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Pruritus: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Pruritus: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Pruritus: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '481', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Pruritus: mild (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Pruritus: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Pruritus: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Pruritus: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '454', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Pruritus: Week 24 mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Pruritus: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Pruritus: 24 severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Pruritus: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '429', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Pruritus: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Pruritus: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Pruritus: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Pruritus: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '418', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Pruritus: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Pruritus: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Pruritus: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Pruritus: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '457', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Pruritus: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Pruritus: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Pruritus: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Baseline Burning/Stinging: none 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'groupId': 'OG000'}]}]}, {'title': 'Week 4: Burning/Stinging: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Burning/Stinging: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Burning/Stinging: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Burning/Stinging: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '463', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Burning/Stinging: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Burning/Stinging: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Burning/Stinging: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Burning/Stinging: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '436', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Burning/Stinging: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Burning/Stinging: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Burning/Stinging: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Burning/Stinging: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '422', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Burning/Stinging: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Burning/Stinging: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Burning/Stinging: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Burning/Stinging: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '411', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Burning/Stinging: mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Burning/Stinging: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Burning/Stinging: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Burning/Stinging: none (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '451', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Burning/Stinging: mild (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Burning/Stinging: moderate (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 40/ET: Burning/Stinging: severe (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 4, Week 12, Week 24, Week 36, Week 40', 'description': "Analysis of cutaneous tolerability scores at each visit through end of treatment. Baseline is the Week 12 assessment from the previous study (NI-AC301 or NI-AC302). The Cutaneous Tolerability Assessment scale consisted of the investigator's assessment of erythema, scaling, and dryness at the time the assessment was made. Pruritus and burning/stinging were based on the subject's report for the previous 24 hours. Each component was graded on a scale of 0-3, with 0 being none (not present) and 3 being severe. Higher scores indicated a higher severity of reaction.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: per the Statistical Analysis Plan, data are presented for the combined study population of 601 subjects.'}, {'type': 'SECONDARY', 'title': 'Inflammatory Lesion Counts by Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SB204 4% Experienced', 'description': 'Subjects who received SB204 % QD in the parent trial (NI-AC301 or NI-AC302)'}, {'id': 'OG001', 'title': 'SB204 Naive', 'description': 'Subjects who received vehicle gel in the parent trial (NI-AC301 or NI-AC302) and received SB204 4% QD in this trial.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.2', 'spread': '9.94', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '10.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.2', 'spread': '9.98', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '10.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '9.66', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '9.74', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.3', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '9.41', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.3', 'spread': '8.39', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '9.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '8.13', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '8.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 40/ET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '8.47', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '9.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 40', 'description': 'Absolute count of inflammatory lesions at each visit (face only)--safety population', 'unitOfMeasure': 'number of inflammatory lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Non-Inflammatory Lesion Counts by Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SB204 4% Experienced', 'description': 'Subjects who received SB204 4% in the parent study.'}, {'id': 'OG001', 'title': 'SB204 Naive', 'description': 'Subjects who received vehicle gel in the parent study and SB204 4% in this open label study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.6', 'spread': '16.08', 'groupId': 'OG000'}, {'value': '25.5', 'spread': '18.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.9', 'spread': '16.27', 'groupId': 'OG000'}, {'value': '23.0', 'spread': '16.07', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.7', 'spread': '15.14', 'groupId': 'OG000'}, {'value': '21.5', 'spread': '16.09', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.2', 'spread': '14.67', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '13.20', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.0', 'spread': '13.19', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '13.06', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '13.77', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '12.59', 'groupId': 'OG001'}]}]}, {'title': 'Week 40/ET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.7', 'spread': '14.64', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '14.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 40', 'description': 'Absolute count of non-inflammatory lesions by study visit (face only)', 'unitOfMeasure': 'number of non-inflammatory lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SB204 4% Experienced', 'description': 'Subjects who received SB204 4% in the parent study (NI-AC301 or NI-AC302) were considered SB204 experienced at the time of enrollment into NI-AC303.'}, {'id': 'FG001', 'title': 'SB204 Naive', 'description': 'Subjects who received vehicle gel in the parent study (NI-AC301 or NI-AC302) were considered SB204 naive at the time of enrollment into this study (NI-AC303). They began treatment with SB204 on the day of enrollment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}, {'groupId': 'FG001', 'numSubjects': '305'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '216'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '89'}]}]}], 'recruitmentDetails': 'Subjects who successfully completed one of the pivotal parent studies NI-AC301 and NI-AC302 were eligible to roll over into NI-AC303. Those subjects assigned to SB204 once daily (QD) in the parent study continued to receive open label SB204 for 40 more weeks (total \\~52 weeks) and are denoted as SB204 experienced. Those subjects assigned to vehicle gel in the parent study were rolled over and received open label SB204 in this trial (total \\~40 weeks of SB204 treatment) and are denoted SB204 naive.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '601', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SB204 Experienced', 'description': 'Subjects who were assigned to and received SB204 in the pivotal study (NI-AC301 or NI-AC302) were denoted as being SB204 experienced when they rolled over into the open-label long term safety study (NI-AC303). These subjects were on treatment with SB204 for up to 52 weeks (12 weeks in the pivotal study + 40 weeks in this study.'}, {'id': 'BG001', 'title': 'SB204 Naive', 'description': 'Subjects who were assigned to and received Vehicle Gel in the pivotal study (NI-AC301 or NI-AC302) were denoted as being SB204 naive when they rolled over into the open-label long term safety study (NI-AC303). These subjects were on treatment with SB204 for up to 40 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.4', 'spread': '8.86', 'groupId': 'BG000'}, {'value': '21.0', 'spread': '8.66', 'groupId': 'BG001'}, {'value': '21.2', 'spread': '8.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Juvenile (<18 years)', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}]}, {'title': 'Adult (≥18 years)', 'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '357', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '368', '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': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', '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': '58', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', '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': '296', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '601', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parent study (NI-AC301 or NI-AC302)', 'classes': [{'title': 'NI-AC301', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}]}, {'title': 'NI-AC302', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population. As this was an open label, long term safety study, all subjects were in the safety population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-11-09', 'size': 536655, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-25T08:18', 'hasProtocol': True}, {'date': '2017-04-12', 'size': 489752, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-25T08:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 601}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'dispFirstSubmitDate': '2018-09-05', 'completionDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2016-06-09', 'dispFirstSubmitQcDate': '2018-09-05', 'resultsFirstSubmitDate': '2023-01-25', 'studyFirstSubmitQcDate': '2016-06-13', 'dispFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-10', 'studyFirstPostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303)', 'timeFrame': 'Baseline', 'description': 'This outcome measure shows the number of subjects with at least one ongoing adverse event from the pivotal studies (NI-AC301 and NI-AC302) at the time they rolled over into this study (NI-AC303). The final study visit (Week 12) for the pivotal studies served as the Baseline visit for this study. Subjects who were assigned to SB204 in the pivotal studies are denoted as SB204 Experienced and subjects who were assigned to Vehicle Gel on the pivotal studies are denoted as SB204 Naive.'}, {'measure': 'Number of Subjects With Treatment Emergent Adverse Events', 'timeFrame': 'Week 40/End of Treatment', 'description': 'Number of subjects with adverse events that had an onset date on or after entry into study NI-AC303.'}], 'secondaryOutcomes': [{'measure': 'Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)', 'timeFrame': 'Baseline, Week 4, Week 12, Week 24, Week 36, Week 40', 'description': "Analysis of cutaneous tolerability scores at each visit through end of treatment. Baseline is the Week 12 assessment from the previous study (NI-AC301 or NI-AC302). The Cutaneous Tolerability Assessment scale consisted of the investigator's assessment of erythema, scaling, and dryness at the time the assessment was made. Pruritus and burning/stinging were based on the subject's report for the previous 24 hours. Each component was graded on a scale of 0-3, with 0 being none (not present) and 3 being severe. Higher scores indicated a higher severity of reaction."}, {'measure': 'Inflammatory Lesion Counts by Study Visit', 'timeFrame': 'Baseline through Week 40', 'description': 'Absolute count of inflammatory lesions at each visit (face only)--safety population'}, {'measure': 'Non-Inflammatory Lesion Counts by Study Visit', 'timeFrame': 'Baseline through Week 40', 'description': 'Absolute count of non-inflammatory lesions by study visit (face only)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.', 'detailedDescription': 'A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have completed 12 weeks of treatment in NI-AC301 or NI-AC302\n\nExclusion Criteria:\n\n* Terminated early from an SB204 Phase 3 pivotal study for any reason\n* Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants stopping study drug application\n* Have used medications or vitamins during the 12 weeks immediately preceding this study which were reported to exacerbate acne.'}, 'identificationModule': {'nctId': 'NCT02798120', 'briefTitle': 'P3 Long Term Safety Study of Once Daily SB204 in Acne', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novan, Inc.'}, 'officialTitle': 'A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris', 'orgStudyIdInfo': {'id': 'NI-AC303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SB204 4%', 'description': 'All subjects received SB204 4% once daily (QD) in this open label study. Subjects assigned to SB204 4% QD in the parent study (NI-AC301/302) continued to receive SB204 for 40 more weeks. Subjects assigned to Vehicle Gel in the parent study (NI-AC301/302) received SB204 4% QD in this open label study.', 'interventionNames': ['Drug: SB204 4%']}], 'interventions': [{'name': 'SB204 4%', 'type': 'DRUG', 'otherNames': ['NVN1000'], 'description': 'Open label, topical SB204 4%', 'armGroupLabels': ['SB204 4%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35202', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'CIL #138', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'CIL #218', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'CIL #189', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'CIL #146', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'CIL #139', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'CIL #216', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'CIL #186', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'CIL #210', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'CIL #174', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'CIL #213', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'CIL #209', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'CIL #190', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'CIL #161', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'CIL #113', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'CIL #195', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'CIL #119', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '95405', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'CIL #199', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #103', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #208', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33030', 'city': 'Homestead', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #212', 'geoPoint': {'lat': 25.46872, 'lon': -80.47756}}, {'zip': '33406', 'city': 'Lauderdale Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #222', 'geoPoint': {'lat': 26.16647, 'lon': -80.20838}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #170', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33166', 'city': 'Miami Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #204', 'geoPoint': {'lat': 25.82232, 'lon': -80.2895}}, {'zip': '32814', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #172', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #185', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #203', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #110', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '32771', 'city': 'Sanford', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #227', 'geoPoint': {'lat': 28.80055, 'lon': -81.27312}}, {'zip': '33413', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #211', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '33716', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #176', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #152', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #229', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33634', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #144', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33414', 'city': 'Wellington', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #153', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '30263', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'facility': 'CIL #116', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'CIL #143', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '47150', 'city': 'New Albany', 'state': 'Indiana', 'country': 'United States', 'facility': 'CIL #175', 'geoPoint': {'lat': 38.28562, 'lon': -85.82413}}, {'zip': '66215', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'CIL #191', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'CIL #215', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'CIL #117', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40475', 'city': 'Richmond', 'state': 'Kentucky', 'country': 'United States', 'facility': 'CIL #194', 'geoPoint': {'lat': 37.74786, 'lon': -84.29465}}, {'zip': '71203', 'city': 'Monroe', 'state': 'Louisiana', 'country': 'United States', 'facility': 'CIL #219', 'geoPoint': {'lat': 32.50931, 'lon': -92.1193}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'CIL #187', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68701', 'city': 'Norfolk', 'state': 'Nebraska', 'country': 'United States', 'facility': 'CIL #148', 'geoPoint': {'lat': 42.02834, 'lon': -97.417}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'CIL #140', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89129', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'CIL #182', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'CIL #201', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '07042', 'city': 'Montclair', 'state': 'New Jersey', 'country': 'United States', 'facility': 'CIL #141', 'geoPoint': {'lat': 40.82593, 'lon': -74.20903}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'CIL #156', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'CIL #108', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CIL #221', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '45246', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'CIL #169', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45255', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'CIL #226', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97030', 'city': 'Gresham', 'state': 'Oregon', 'country': 'United States', 'facility': 'CIL #237', 'geoPoint': {'lat': 45.49818, 'lon': -122.43148}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'CIL #200', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19008', 'city': 'Broomall', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CIL #137', 'geoPoint': {'lat': 39.9815, 'lon': -75.35658}}, {'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CIL #178', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'CIL #217', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '76011', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'CIL #198', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '78735', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'CIL #160', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77701', 'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': 'CIL #154', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'zip': '77802', 'city': 'Bryan', 'state': 'Texas', 'country': 'United States', 'facility': 'CIL #184', 'geoPoint': {'lat': 30.67436, 'lon': -96.36996}}, {'zip': '77055', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'CIL #188', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'CIL #151', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '75234', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'CIL #168', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78218', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'CIL #224', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'CIL #106', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'CIL #105', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'CIL #231', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Joyce Rico', 'role': 'STUDY_CHAIR', 'affiliation': 'Novan, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novan, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Chiltern International Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}