Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 8:50 AM
Study NCT ID:
NCT02242760
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2014-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris
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 (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Vehicle Gel QD', 'description': 'Vehicle Gel: Applied topically once daily', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 1, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle Gel BID', 'description': 'Vehicle Gel: Applied topically twice daily', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 4, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SB204 2% BID', 'description': 'SB204 2%: Applied topically twice daily', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 4, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'SB204 4% QD', 'description': 'SB204 4%: Applied topically once daily', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 5, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'SB204 4% BID', 'description': 'SB204 4%: Applied topically twice daily', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 3, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Application site dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'Peritoneal haemorrhage', 'notes': 'Event required hospitalization; considered unlikely to be related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change in Inflammatory Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Gel QD', 'description': 'Vehicle Gel: Applied topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Gel BID', 'description': 'Vehicle Gel: Applied topically twice daily'}, {'id': 'OG002', 'title': 'SB204 2% BID', 'description': 'SB204 2%: Applied topically twice daily'}, {'id': 'OG003', 'title': 'SB204 4% QD', 'description': 'SB204 4%: Applied topically once daily'}, {'id': 'OG004', 'title': 'SB204 4% BID', 'description': 'SB204 4%: Applied topically twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.7', 'spread': '10.51', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '12.77', 'groupId': 'OG001'}, {'value': '-11.2', 'spread': '9.48', 'groupId': 'OG002'}, {'value': '-11.3', 'spread': '9.66', 'groupId': 'OG003'}, {'value': '-10.4', 'spread': '9.65', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Change in inflammatory lesion count from Baseline to Week 12', 'unitOfMeasure': 'inflammatory acne lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population (ITT)'}, {'type': 'PRIMARY', 'title': 'Absolute Change in Non-inflammatory Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Gel QD', 'description': 'Vehicle Gel: Applied topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Gel BID', 'description': 'Vehicle Gel: Applied topically twice daily'}, {'id': 'OG002', 'title': 'SB204 2% BID', 'description': 'SB204 2%: Applied topically twice daily'}, {'id': 'OG003', 'title': 'SB204 4% QD', 'description': 'SB204 4%: Applied topically once daily'}, {'id': 'OG004', 'title': 'SB204 4% BID', 'description': 'SB204 4%: Applied topically twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.4', 'spread': '16.16', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '18.16', 'groupId': 'OG001'}, {'value': '-12.3', 'spread': '14.91', 'groupId': 'OG002'}, {'value': '-14.1', 'spread': '15.13', 'groupId': 'OG003'}, {'value': '-11.1', 'spread': '17.65', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Absolute Change in non-inflammatory lesion count from Baseline to Week 12', 'unitOfMeasure': 'non-inflammatory acne lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population'}, {'type': 'PRIMARY', 'title': 'Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Gel QD', 'description': 'Vehicle Gel: Applied topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Gel BID', 'description': 'Vehicle Gel: Applied topically twice daily'}, {'id': 'OG002', 'title': 'SB204 2% BID', 'description': 'SB204 2%: Applied topically twice daily'}, {'id': 'OG003', 'title': 'SB204 4% QD', 'description': 'SB204 4%: Applied topically once daily'}, {'id': 'OG004', 'title': 'SB204 4% BID', 'description': 'SB204 4%: Applied topically twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Week 12', 'description': "Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome.\n\nGrade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent to treat (ITT) population. Count of participants = number of participants achieving success on the Investigator's Global Assessment at Week 12: a score of clear (0) or almost clear (1) and at least 2 grades less than Baseline."}, {'type': 'SECONDARY', 'title': 'Percent Change in Inflammatory Lesion Count From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Gel QD', 'description': 'Vehicle Gel: Applied topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Gel BID', 'description': 'Vehicle Gel: Applied topically twice daily'}, {'id': 'OG002', 'title': 'SB204 2% BID', 'description': 'SB204 2%: Applied topically twice daily'}, {'id': 'OG003', 'title': 'SB204 4% QD', 'description': 'SB204 4%: Applied topically once daily'}, {'id': 'OG004', 'title': 'SB204 4% BID', 'description': 'SB204 4%: Applied topically twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.2', 'spread': '34.78', 'groupId': 'OG000'}, {'value': '-12.5', 'spread': '48.25', 'groupId': 'OG001'}, {'value': '-41.9', 'spread': '31.35', 'groupId': 'OG002'}, {'value': '-41.6', 'spread': '36.6', 'groupId': 'OG003'}, {'value': '-42.1', 'spread': '35.12', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The percent change in inflammatory lesion count from Baseline to Week 12', 'unitOfMeasure': 'Percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Gel QD', 'description': 'Vehicle Gel: Applied topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Gel BID', 'description': 'Vehicle Gel: Applied topically twice daily'}, {'id': 'OG002', 'title': 'SB204 2% BID', 'description': 'SB204 2%: Applied topically twice daily'}, {'id': 'OG003', 'title': 'SB204 4% QD', 'description': 'SB204 4%: Applied topically once daily'}, {'id': 'OG004', 'title': 'SB204 4% BID', 'description': 'SB204 4%: Applied topically twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.2', 'spread': '42.54', 'groupId': 'OG000'}, {'value': '-14.3', 'spread': '54.10', 'groupId': 'OG001'}, {'value': '-33.8', 'spread': '33.91', 'groupId': 'OG002'}, {'value': '-36.8', 'spread': '35.54', 'groupId': 'OG003'}, {'value': '-33.0', 'spread': '40.16', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The percent change in non-inflammatory lesion count from Baseline to Week 12', 'unitOfMeasure': 'Percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Median Time to Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Vehicle', 'description': 'Vehicle Gel applied once or twice daily according to randomization'}, {'id': 'OG001', 'title': 'SB204 2% BID', 'description': 'SB204 2%: Applied topically twice daily'}, {'id': 'OG002', 'title': 'SB204 4% QD', 'description': 'SB204 4%: Applied topically once daily'}, {'id': 'OG003', 'title': 'SB204 4% BID', 'description': 'SB204 4%: Applied topically twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '12.1'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '14'}, {'value': '4.1', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '12.3'}, {'value': '4.0', 'groupId': 'OG003', 'lowerLimit': '1.6', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through Week 12', 'description': 'Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population. The vehicle QD and vehicle BID arms were combined per the study Statistical Analysis Plan: "Median time to improvement will be calculated using the Kaplan-Meier method, and the Kaplan-Meier curves will be presented for each active treatment group and the combined Vehicle group."'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vehicle Gel QD', 'description': 'Vehicle Gel: Applied topically once daily'}, {'id': 'FG001', 'title': 'Vehicle Gel BID', 'description': 'Vehicle Gel: Applied topically twice daily'}, {'id': 'FG002', 'title': 'SB204 2% BID', 'description': 'SB204 2%: Applied topically twice daily'}, {'id': 'FG003', 'title': 'SB204 4% QD', 'description': 'SB204 4%: Applied topically once daily'}, {'id': 'FG004', 'title': 'SB204 4% BID', 'description': 'SB204 4%: Applied topically twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '53'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '52'}]}, {'type': 'Number of Subjects Excluded From ITT Population', 'comment': 'One subject in the SB204 4% BID group was not dispensed study medication after randomization.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '48'}, {'groupId': 'FG004', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '212', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Vehicle Gel QD', 'description': 'Vehicle Gel: Applied topically once daily'}, {'id': 'BG001', 'title': 'Vehicle Gel BID', 'description': 'Vehicle Gel: Applied topically twice daily'}, {'id': 'BG002', 'title': 'SB204 2% BID', 'description': 'SB204 2%: Applied topically twice daily'}, {'id': 'BG003', 'title': 'SB204 4% QD', 'description': 'SB204 4%: Applied topically once daily'}, {'id': 'BG004', 'title': 'SB204 4% BID', 'description': 'SB204 4%: Applied topically twice daily'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'SB204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '156', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '20.1', 'spread': '6.81', 'groupId': 'BG002'}, {'value': '18.8', 'spread': '5.00', 'groupId': 'BG003'}, {'value': '20.1', 'spread': '6.94', 'groupId': 'BG004'}, {'value': '19.6', 'spread': '6.30', 'groupId': 'BG005'}]}]}, {'title': 'Vehicle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '16.7', 'spread': '4.84', 'groupId': 'BG000'}, {'value': '19.7', 'spread': '6.33', 'groupId': 'BG001'}, {'value': '18.2', 'spread': '5.81', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'SB204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '156', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '84', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '72', 'groupId': 'BG005'}]}]}, {'title': 'Vehicle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'SB204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '156', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '124', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}, {'title': 'Vehicle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'SB204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '156', 'groupId': 'BG005'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '41', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '113', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}, {'title': 'Vehicle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '212', 'groupId': 'BG005'}]}], 'categories': [{'title': 'SB204', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '156', 'groupId': 'BG005'}]}, {'title': 'Vehicle', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The SAP specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. The SB204 cohorts are presented in Row 1--columns 3, 4, and 5 represent the individual SB204 cohorts, while column 6 represents the combined SB204 cohort. The vehicle gel cohorts are presented in Row 2. The individual vehicle cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.'}], 'populationDescription': 'Intent to Treat (ITT) population: all study subjects who were randomized and dispensed study medication. One subject in the SB204 4% BID group was randomized but did not receive study medication.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-10-16', 'size': 1371767, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-17T10:16', 'hasProtocol': True}, {'date': '2015-05-19', 'size': 2088901, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-17T10:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'dispFirstSubmitDate': '2017-12-18', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-26', 'studyFirstSubmitDate': '2014-09-10', 'dispFirstSubmitQcDate': '2017-12-18', 'resultsFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2014-09-15', 'dispFirstPostDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-26', 'studyFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change in Inflammatory Lesion Counts', 'timeFrame': 'Baseline and Week 12', 'description': 'Change in inflammatory lesion count from Baseline to Week 12'}, {'measure': 'Absolute Change in Non-inflammatory Lesion Counts', 'timeFrame': 'Baseline and Week 12', 'description': 'Absolute Change in non-inflammatory lesion count from Baseline to Week 12'}, {'measure': 'Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment', 'timeFrame': 'Baseline and Week 12', 'description': "Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome.\n\nGrade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)"}], 'secondaryOutcomes': [{'measure': 'Percent Change in Inflammatory Lesion Count From Baseline to Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The percent change in inflammatory lesion count from Baseline to Week 12'}, {'measure': 'Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The percent change in non-inflammatory lesion count from Baseline to Week 12'}, {'measure': 'Median Time to Improvement', 'timeFrame': 'Baseline through Week 12', 'description': 'Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acne'], 'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'This is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.', 'detailedDescription': 'A randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe acne\n* 25-70 non-inflammatory lesions at Baseline\n* 20-40 inflammatory lesions at Baseline\n\nExclusion Criteria:\n\n* Subjects with known allergy to any component of the test material or vehicle\n* Women who are pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT02242760', 'briefTitle': 'P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novan, Inc.'}, 'officialTitle': 'A Phase 2, Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled Study Comparing the Efficacy, Tolerability, and Safety of SB204 Gel and Vehicle Gel Once or Twice Daily in the Treatment of Acne Vulgaris', 'orgStudyIdInfo': {'id': 'NI-AC202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SB204 2% Twice daily', 'description': 'Twice daily SB204 2%', 'interventionNames': ['Drug: SB204 2%']}, {'type': 'EXPERIMENTAL', 'label': 'SB204 4% daily', 'description': 'Once daily SB204 4%', 'interventionNames': ['Drug: SB204 4%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Gel Daily', 'description': 'Vehicle Gel Daily', 'interventionNames': ['Drug: Vehicle Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Gel Twice Daily', 'description': 'Twice daily Vehicle Gel', 'interventionNames': ['Drug: Vehicle Gel']}, {'type': 'EXPERIMENTAL', 'label': 'SB204 4% Twice Daily', 'description': 'Twice daily SB204 4%', 'interventionNames': ['Drug: SB204 4%']}], 'interventions': [{'name': 'SB204 2%', 'type': 'DRUG', 'otherNames': ['NVN1000'], 'description': 'Applied topically twice daily', 'armGroupLabels': ['SB204 2% Twice daily']}, {'name': 'SB204 4%', 'type': 'DRUG', 'otherNames': ['NVN1000'], 'description': 'Applied topically daily', 'armGroupLabels': ['SB204 4% Twice Daily', 'SB204 4% daily']}, {'name': 'Vehicle Gel', 'type': 'DRUG', 'otherNames': ['Placeco'], 'description': 'Applied topically twice and once daily', 'armGroupLabels': ['Vehicle Gel Daily', 'Vehicle Gel Twice Daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Qst acne site #1', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'QST Site #118', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'QST Site #111', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'QST Site #113', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'QST Site #119', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'QST Site #103', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'QST Site # 110', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '302636', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'facility': 'QST Site # 116', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'QST Site #117', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'QST Site #112', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48088', 'city': 'Warren', 'state': 'Michigan', 'country': 'United States', 'facility': 'QST Site #120', 'geoPoint': {'lat': 42.49044, 'lon': -83.01304}}, {'zip': '55432', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'QST Site # 121', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10155', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'QST Site #107', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'QST Site #108', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '14625', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'QST Site #109', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11790', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'QST Site #104', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'QST Site # 102', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'QST Site #106', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'QST #105', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'QST Site #114', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'M J Rico, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novan, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novan, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}