Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-01-02 @ 5:03 AM
Study NCT ID:
NCT02322866
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2014-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of 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': 'C000629276', 'term': 'sarecycline'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 157 Days', 'description': 'The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.', 'otherNumAtRisk': 513, 'deathsNumAtRisk': 513, 'otherNumAffected': 0, 'seriousNumAtRisk': 513, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Sarecycline', 'description': 'Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.', 'otherNumAtRisk': 513, 'deathsNumAtRisk': 513, 'otherNumAffected': 0, 'seriousNumAtRisk': 513, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 513, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 513, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 19.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 513, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 513, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 19.1'}, {'term': 'Abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 513, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 513, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 19.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 513, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 513, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 19.1'}, {'term': 'Oppositional defiant disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 513, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 513, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Sarecycline', 'description': 'Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-15.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '-2.9', 'pValueComment': 'Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'estimateComment': 'sarecycline - placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'unitOfMeasure': 'lesion count', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants.'}, {'type': 'PRIMARY', 'title': "Percentage of Participants With Investigator's Global Assessment (IGA) Scale Success at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Sarecycline', 'description': 'Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '22.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.30', 'ciLowerLimit': '2.53', 'ciUpperLimit': '12.07', 'pValueComment': 'P-values were based on the test of general association between the response and treatment group using Cochran-Mantel-Haenszel test with pooled site as stratification factor.', 'estimateComment': 'sarecycline - placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The investigator assessed the participant's inflammatory lesions on the face using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). The percentage of participants who achieved success is reported. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Sarecycline', 'description': 'Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-35.4', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '-49.9', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.4', 'ciLowerLimit': '-19.4', 'ciUpperLimit': '-9.5', 'pValueComment': 'Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'estimateComment': 'sarecycline - placebo', 'groupDescription': 'Percent Change from Baseline to Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'unitOfMeasure': 'percent change in lesion counts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Sarecycline', 'description': 'Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.9', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-44.5', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.6', 'ciLowerLimit': '-17.3', 'ciUpperLimit': '-7.9', 'pValueComment': 'Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'estimateComment': 'sarecycline - placebo', 'groupDescription': 'Percent Change from Baseline to Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 9', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'unitOfMeasure': 'percent change in lesion counts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Sarecycline', 'description': 'Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-39.1', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.8', 'ciLowerLimit': '-16.1', 'ciUpperLimit': '-7.5', 'pValueComment': 'Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'estimateComment': 'sarecycline - placebo', 'groupDescription': 'Percent Change from Baseline to Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 6', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'unitOfMeasure': 'percent change in lesion counts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Sarecycline', 'description': 'Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.6', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-28.0', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.4', 'ciLowerLimit': '-13.5', 'ciUpperLimit': '-5.3', 'pValueComment': 'Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'estimateComment': 'sarecycline - placebo', 'groupDescription': 'Percent Change from Baseline to Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 3', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'unitOfMeasure': 'percent change in lesion counts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Sarecycline', 'description': 'Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-13.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '-2.5', 'pValueComment': 'Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'estimateComment': 'sarecycline - placebo', 'groupDescription': 'Change from Baseline to Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 9', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'unitOfMeasure': 'lesion count', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Sarecycline', 'description': 'Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-11.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.7', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '-2.4', 'pValueComment': 'Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'estimateComment': 'sarecycline - placebo', 'groupDescription': 'Change from Baseline to Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 6', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'unitOfMeasure': 'lesion count', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Sarecycline', 'description': 'Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '-1.7', 'pValueComment': 'Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'estimateComment': 'sarecycline - placebo', 'groupDescription': 'Change from Baseline to Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 3', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.', 'unitOfMeasure': 'lesion count', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.'}, {'id': 'FG001', 'title': 'Sarecycline', 'description': 'Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '515'}, {'groupId': 'FG001', 'numSubjects': '519'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '444'}, {'groupId': 'FG001', 'numSubjects': '433'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '86'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Noncompliance with Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'BG000'}, {'value': '519', 'groupId': 'BG001'}, {'value': '1034', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.'}, {'id': 'BG001', 'title': 'Sarecycline', 'description': 'Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '≥9 and <12 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': '≥12 and <18 years', 'categories': [{'measurements': [{'value': '256', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '483', 'groupId': 'BG002'}]}]}, {'title': '≥18 years', 'categories': [{'measurements': [{'value': '255', 'groupId': 'BG000'}, {'value': '285', 'groupId': 'BG001'}, {'value': '540', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '292', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '607', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '223', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '427', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) Population included all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1034}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2014-12-15', 'resultsFirstSubmitDate': '2018-04-03', 'studyFirstSubmitQcDate': '2014-12-22', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-03', 'studyFirstPostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 12', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.'}, {'measure': "Percentage of Participants With Investigator's Global Assessment (IGA) Scale Success at Week 12", 'timeFrame': 'Week 12', 'description': "The investigator assessed the participant's inflammatory lesions on the face using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). The percentage of participants who achieved success is reported. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate."}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.'}, {'measure': 'Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9', 'timeFrame': 'Baseline (Day 1) to Week 9', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.'}, {'measure': 'Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6', 'timeFrame': 'Baseline (Day 1) to Week 6', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.'}, {'measure': 'Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3', 'timeFrame': 'Baseline (Day 1) to Week 3', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.'}, {'measure': 'Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9', 'timeFrame': 'Baseline (Day 1) to Week 9', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.'}, {'measure': 'Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6', 'timeFrame': 'Baseline (Day 1) to Week 6', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.'}, {'measure': 'Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3', 'timeFrame': 'Baseline (Day 1) to Week 3', 'description': 'Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \\< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \\> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acne'], 'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of an approximate 1.5 mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent or assent form\n* Male/female, 9 to 45 years of age, inclusive\n* Body weight between 33 and 136 kg, inclusive\n* Facial acne vulgaris with:\n* 20-50 inflammatory lesions (papules, pustules and nodules)\n* 30-100 noninflammatory lesions (open and closed comedones)\n* No more than 2 nodules\n* Investigator's Global Assessment (IGA) score of moderate (3) or severe (4)\n* Negative urine pregnancy test at baseline - females of childbearing potential\n* Agrees to use an effective method of contraception throughout the study\n* Refrain from use of any other acne medications and medicated cleansers, and avoid excessive sun exposure and tanning booths for duration of study\n* Able to fulfill the requirements of protocol, indicated willingness to participate in the study and agrees to all study procedures (including mandatory photography) by providing written informed consent/assent and an authorization to disclose protected health information (PHI).\n\nExclusion Criteria:\n\n* Has a dermatological condition of the face that could interfere with the clinical evaluations\n* Has a history of any of the following:\n* Allergy to tetracycline-class antibiotics or to any ingredient in the study drug\n* Pseudomembranous colitis or antibiotic-associated colitis\n* Treated for any type of cancer within the last 6 months\n* Has known resistance to other tetracyclines\n* Has receive any of the following treatments within 12 weeks of screening:\n* Systemic retinoids\n* Systemic corticosteroids\n* Androgens/anti-androgenic therapy (eg, anabolic steroids, spironolactone)\n* Non-medicated procedures for the treatment of acne (eg, laser, light or ThermaClear)\n* Has used any acne affecting treatment without an appropriate washout period\n* Has initiated hormonal contraceptive use within 12 weeks prior to screening or plans to initiate or switch hormonal contraceptive products during the study period\n* Is pregnant, lactating or planning a pregnancy during the study period\n* Has any other disorder causing hyperandrogenism including, but not limited to polycystic ovary syndrome, adrenal or ovarian tumors, Cushings disease or congenital adrenal hyperplasia\n* Has drug-induced acne\n* Has significant intercurrent illness, psychiatric disposition or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study\n* Is currently participating, or has participated within 30 days prior to the screening period in an investigational drug or device study\n* Has previously participated in any clinical trial involving the use of sarecycline\n* Is judged by the Investigator to be unsuitable for any reason."}, 'identificationModule': {'nctId': 'NCT02322866', 'briefTitle': 'Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne', 'organization': {'class': 'INDUSTRY', 'fullName': 'Almirall, S.A.'}, 'officialTitle': 'A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 1.5 mg/kg Per Day of Sarecycline Compared to Placebo in the Treatment of Acne Vulgaris', 'orgStudyIdInfo': {'id': 'SC1402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sarecycline', 'description': 'Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks.', 'interventionNames': ['Drug: Sarecycline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sarecycline', 'type': 'DRUG', 'description': '1.5 mg/kg/day taken orally at the same time each day.', 'armGroupLabels': ['Sarecycline']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo-matching sarecycline tablets, taken orally at the same time each day.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Warner Chilcott Research Site (Site #206)', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 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