Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-24 @ 10:39 PM
Study NCT ID:
NCT02672332
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2016-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
P3 Study in Acne Comparing Once Daily SB204 and Vehicle
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': '919-485-8080', 'title': 'Cathy White, Vice President, Drug Development Operations', 'organization': 'Novan, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected after the subject signed the informed consent and completed any study assessment until the end of the final study visit, approximately 12 weeks for most subjects.', 'description': 'Adverse events were collected for all subjects who were randomized and received at least one dose of study medication. Two subjects who were randomized to the Vehicle group received SB204 and per the definition of the Safety Population in the Statistical Analysis Plan, these subjects were analyzed in the SB204 group. Therefore, 654 subjects were in the SB204 group and 652 subjects were in the Vehicle group for analyses of all cause mortality, adverse events and serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'SB204 4%', 'description': 'SB204 4% topically once daily', 'otherNumAtRisk': 654, 'deathsNumAtRisk': 654, 'otherNumAffected': 66, 'seriousNumAtRisk': 654, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle Gel', 'description': 'Vehicle Gel (placebo comparator) topically once daily', 'otherNumAtRisk': 652, 'deathsNumAtRisk': 652, 'otherNumAffected': 10, 'seriousNumAtRisk': 652, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 654, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 652, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 654, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 652, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 654, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 652, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 654, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 652, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Application site dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 654, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 652, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 654, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Death', 'notes': 'Subject was a 66 year old male; died of natural causes (unknown) and the event was considered to be not related to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 654, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 654, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bulimia nervosa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 654, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 654, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change From Baseline in Inflammatory Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '653', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SB204 4%', 'description': 'SB204 4% topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle Gel (placebo comparator) topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.4', 'spread': '10.30', 'groupId': 'OG000'}, {'value': '-11.3', 'spread': '10.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The absolute change from Baseline in inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Inflammatory lesions included papules, pustules, nodules, and cysts.', 'unitOfMeasure': 'inflammatory acne lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent To Treat population (ITT)'}, {'type': 'PRIMARY', 'title': 'Absolute Change From Baseline in Non-inflammatory Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '653', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SB204 4%', 'description': 'SB204 4% topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle Gel (placebo comparator) topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.0', 'spread': '16.36', 'groupId': 'OG000'}, {'value': '-13.5', 'spread': '16.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The absolute change from Baseline in non-inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Non-inflammatory lesions included open comedones (blackheads) and closed comedones (whiteheads).', 'unitOfMeasure': 'non-inflammatory acne lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population (ITT)'}, {'type': 'PRIMARY', 'title': 'Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '592', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SB204 4%', 'description': 'SB204 4% topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle Gel (placebo comparator) topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Week 12', 'description': 'Proportion of subjects with Investigator Global Assessment (IGA) Success at Week 12 is defined as an IGA score of 0 or 1 (Clear/Almost Clear) and at least a 2 grade improvement from Baseline. The IGA scale is as follows:\n\nGrade Description 0 Clear: Clear skin with no inflammatory or non-inflammatory lesions.\n\n1. Almost clear: Rare non-inflammatory lesions with rare papules (papules may be resolving and hyperpigmented, though not pink-red).\n2. Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions.\n3. Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one nodulocystic lesion.\n4. Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodulocystic lesions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; subjects who had a Week 12 (study completion) visit.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Inflammatory Lesion Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '653', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SB204 4%', 'description': 'SB204 4% topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle Gel (placebo comparator) topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.9', 'spread': '36.65', 'groupId': 'OG000'}, {'value': '-43.1', 'spread': '38.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The percent change from baseline in inflammatory lesion count', 'unitOfMeasure': 'Percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Non-inflammatory Lesion Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '653', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SB204 4%', 'description': 'SB204 4% topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle Gel (placebo comparator) topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-39.6', 'spread': '35.84', 'groupId': 'OG000'}, {'value': '-34.6', 'spread': '41.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The percent change from baseline in non-inflammatory lesion count', 'unitOfMeasure': 'Percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Time to Reduction in Inflammatory Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '494', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SB204 4%', 'description': 'SB204 4% topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle Gel (placebo comparator) topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000', 'lowerLimit': '30.0', 'upperLimit': '37.0'}, {'value': '31.0', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '55.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12', 'description': 'Median time to a 35% reduction in inflammatory lesion count (Kaplan-Meier)', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; overall number of participants analyzed = the # of participants who achieved at least a 35% reduction in their inflammatory lesion counts.'}, {'type': 'SECONDARY', 'title': 'Time to Improvement in IGA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SB204 4%', 'description': 'SB204 4% topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle Gel (placebo comparator) topically once daily'}], 'classes': [{'title': '25% Quartile', 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000', 'lowerLimit': '86.0', 'upperLimit': '90.0'}, {'value': '87.0', 'comment': 'The upper bounds of the CI is not available because not enough subjects achieved a 2 or more grade improvement in their IGA score prior to their last visit.', 'groupId': 'OG001', 'lowerLimit': '86.0', 'upperLimit': 'NA'}]}]}, {'title': '50% Quartile', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median was not estimable due to \\< 50% of subjects achieving a 2 or more grade improvement in their IGA score.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median was not estimable due to \\< 50% of subjects achieving a 2 or more grade improvement in their IGA score.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '75% Quartile', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median was not estimable due to \\< 50% of subjects achieving a 2 or more grade improvement in their IGA score.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median was not estimable due to \\< 50% of subjects achieving a 2 or more grade improvement in their IGA score.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis).', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Overall number of participants analyzed = number of participants who achieved a 2 or more grade improvement in their IGA score. This was a Kaplan-Meier analysis; for both the SB204 4% and Vehicle Gel treatment groups, the median was not estimable due to \\< 50% of subjects achieving a 2 or more grade improvement in their IGA score.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SB204 4%', 'description': 'SB204 4% topically once daily'}, {'id': 'FG001', 'title': 'Vehicle Gel', 'description': 'Vehicle Gel (placebo comparator) topically once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '653'}, {'groupId': 'FG001', 'numSubjects': '654'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '571'}, {'groupId': 'FG001', 'numSubjects': '577'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '77'}]}]}], 'recruitmentDetails': '1300 participants were planned to be recruited from dermatologists and other (e. g. family physicians, research clinics). A total of 1307 participants were randomized. Enrollment began on 22Feb2016 and the last subject completed on 21Dec2016. There were 1306 participants in the intent to treat (ITT) and safety populations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1306', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SB204 4%', 'description': 'SB204 4% topically once daily'}, {'id': 'BG001', 'title': 'Vehicle Gel', 'description': 'Vehicle Gel (placebo comparator) topically once daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1306', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21.1', 'spread': '8.25', 'groupId': 'BG000'}, {'value': '21.3', 'spread': '8.38', 'groupId': 'BG001'}, {'value': '21.2', 'spread': '8.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1306', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '400', 'groupId': 'BG000'}, {'value': '406', 'groupId': 'BG001'}, {'value': '806', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1306', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '456', 'groupId': 'BG000'}, {'value': '455', 'groupId': 'BG001'}, {'value': '911', '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': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'One subject was excluded from the ITT after randomization, prior to receiving study medication due to not meeting inclusion/exclusion criteria.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1306', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '652', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1306', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Investigator Global Assessment', 'classes': [{'title': '0--clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'BG000'}, {'value': '653', 'groupId': 'BG001'}, {'value': '1304', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '1--almost clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'BG000'}, {'value': '653', 'groupId': 'BG001'}, {'value': '1304', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '2--mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'BG000'}, {'value': '653', 'groupId': 'BG001'}, {'value': '1304', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '3--moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'BG000'}, {'value': '653', 'groupId': 'BG001'}, {'value': '1304', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '557', 'groupId': 'BG000'}, {'value': '575', 'groupId': 'BG001'}, {'value': '1132', 'groupId': 'BG002'}]}]}, {'title': '4--severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'BG000'}, {'value': '653', 'groupId': 'BG001'}, {'value': '1304', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Statistical analyses were not reported for the overall study population; they were only reported for the individual treatment groups.'}], 'populationDescription': 'Intent to treat (ITT) population: all study subjects who were randomized and dispensed study medication, and were grouped by the treatment the subject was assigned to at the time of randomization. There were 653 subjects randomized to SB204, but one subject was excluded from the ITT due to not meeting inclusion/exclusion criteria, thereby reducing the Baseline ITT population for SB204 to 652. All efficacy analyses were performed on the ITT population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-06', 'size': 814724, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-02T16:01', 'hasProtocol': True}, {'date': '2017-01-09', 'size': 6149362, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-02T16:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1307}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'dispFirstSubmitDate': '2018-09-05', 'completionDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2016-02-01', 'dispFirstSubmitQcDate': '2018-09-05', 'resultsFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2016-02-01', 'dispFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-10', 'studyFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change From Baseline in Inflammatory Lesion Counts', 'timeFrame': 'Baseline and Week 12', 'description': 'The absolute change from Baseline in inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Inflammatory lesions included papules, pustules, nodules, and cysts.'}, {'measure': 'Absolute Change From Baseline in Non-inflammatory Lesion Counts', 'timeFrame': 'Baseline and Week 12', 'description': 'The absolute change from Baseline in non-inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Non-inflammatory lesions included open comedones (blackheads) and closed comedones (whiteheads).'}, {'measure': 'Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'Proportion of subjects with Investigator Global Assessment (IGA) Success at Week 12 is defined as an IGA score of 0 or 1 (Clear/Almost Clear) and at least a 2 grade improvement from Baseline. The IGA scale is as follows:\n\nGrade Description 0 Clear: Clear skin with no inflammatory or non-inflammatory lesions.\n\n1. Almost clear: Rare non-inflammatory lesions with rare papules (papules may be resolving and hyperpigmented, though not pink-red).\n2. Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions.\n3. Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one nodulocystic lesion.\n4. Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodulocystic lesions'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Inflammatory Lesion Count', 'timeFrame': 'Baseline and Week 12', 'description': 'The percent change from baseline in inflammatory lesion count'}, {'measure': 'Percent Change in Non-inflammatory Lesion Count', 'timeFrame': 'Baseline and Week 12', 'description': 'The percent change from baseline in non-inflammatory lesion count'}, {'measure': 'Time to Reduction in Inflammatory Lesion Counts', 'timeFrame': 'Week 12', 'description': 'Median time to a 35% reduction in inflammatory lesion count (Kaplan-Meier)'}, {'measure': 'Time to Improvement in IGA', 'timeFrame': 'Week 12', 'description': 'Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.', 'detailedDescription': 'This is a double-blind, placebo controlled study in subjects with moderate to severe acne. Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe acne\n* Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones) on the face\n* Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)\n\nExclusion Criteria:\n\n* Women of child-bearing potential who are pregnant, nursing, considering becoming pregnant\n* Any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic acne'}, 'identificationModule': {'nctId': 'NCT02672332', 'briefTitle': 'P3 Study in Acne Comparing Once Daily SB204 and Vehicle', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novan, Inc.'}, 'officialTitle': 'A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of SB204 and Vehicle Gel Once Daily in the Treatment of Acne Vulgaris', 'orgStudyIdInfo': {'id': 'NI-AC301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SB204 4%', 'description': 'SB204 4% topically once daily', 'interventionNames': ['Drug: SB204 4%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Gel', 'description': 'Vehicle Gel topically once daily', 'interventionNames': ['Drug: Vehicle Gel']}], 'interventions': [{'name': 'SB204 4%', 'type': 'DRUG', 'otherNames': ['NVN1000'], 'description': 'Once daily', 'armGroupLabels': ['SB204 4%']}, {'name': 'Vehicle Gel', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo comparator', 'armGroupLabels': ['Vehicle Gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'CIL #146', 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32.71571, 'lon': -117.16472}}, {'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 #173', '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': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #157', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33162', 'city': 'North Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #177', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #150', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'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 #203', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33413', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #211', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'CIL #229', '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': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cil # 179', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'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': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'CIL #180', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '20769', 'city': 'Glenn Dale', 'state': 'Maryland', 'country': 'United States', 'facility': 'CIL #205', 'geoPoint': {'lat': 38.98761, 'lon': -76.82053}}, {'zip': '02169', 'city': 'Quincy', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'CIL #230', 'geoPoint': {'lat': 42.25288, 'lon': -71.00227}}, {'zip': '48183', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'CIL #112', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'CIL #149', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '64506', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'CIL #225', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'CIL #187', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'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': '10155', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'CIL #107', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'CIL #108', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11790', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'CIL #104', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CIL #193', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CIL #166', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45255', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'CIL #226', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'CIL #200', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'CIL #236', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'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': '77701', 'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': 'CIL #154', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'zip': '75010', 'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'facility': 'CIL #162', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'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': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'CIL #171', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'CIL #164', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'CIL #106', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'CIL #114', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Joyce Rico, MD', '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'}}}}