Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-05 @ 12:13 AM
Study NCT ID:
NCT02965456
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2016-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aloncaric@bauschhealth.com', 'phone': '1-510-259-5284', 'title': 'Clinical Operations Director', 'organization': 'Bausch Health Americas, Inc.'}, 'certainAgreement': {'otherDetails': 'Please contact Sponsor directly for additional information.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline (Day 0) up to Week 12', 'description': 'Safety population included all randomized participants who were presumed to have used study drug at least once and who provided at least 1 post baseline evaluation.', 'eventGroups': [{'id': 'EG000', 'title': 'IDP-121 Lotion', 'description': 'IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.', 'otherNumAtRisk': 389, 'deathsNumAtRisk': 389, 'otherNumAffected': 0, 'seriousNumAtRisk': 389, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'IDP-121 Vehicle Lotion', 'description': 'IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.', 'otherNumAtRisk': 398, 'deathsNumAtRisk': 398, 'otherNumAffected': 0, 'seriousNumAtRisk': 398, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Pregnancy', 'notes': 'This is a gender-specific AE. Only female participants were at risk.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDP-121 Lotion', 'description': 'IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'IDP-121 Vehicle Lotion', 'description': 'IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.9', 'spread': '22.70', 'groupId': 'OG000'}, {'value': '-13.9', 'spread': '23.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Threshold for significance at 0.05.', 'groupDescription': 'Analysis was performed using analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Week 12', 'description': 'Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.', 'unitOfMeasure': 'lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study drug. Multiple imputation (Markov Chain Monte Carlo \\[MCMC\\]) was used to impute missing values.'}, {'type': 'PRIMARY', 'title': 'Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDP-121 Lotion', 'description': 'IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'IDP-121 Vehicle Lotion', 'description': 'IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.9', 'spread': '11.99', 'groupId': 'OG000'}, {'value': '-10.7', 'spread': '12.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Threshold for significance at 0.05.', 'groupDescription': 'Analysis was performed using ANCOVA with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.', 'unitOfMeasure': 'lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment Success at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDP-121 Lotion', 'description': 'IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'IDP-121 Vehicle Lotion', 'description': 'IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Threshold for significance at 0.05.', 'groupDescription': "Analysis was performed using a logistic regression test (using Firth's Penalized Likelihood) with factors of treatment group and analysis center.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study drug and evaluable for EGSS score. Multiple imputation (MCMC) was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Noninflammatory Lesion Count to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDP-121 Lotion', 'description': 'IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'IDP-121 Vehicle Lotion', 'description': 'IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.6', 'spread': '44.64', 'groupId': 'OG000'}, {'value': '-31.9', 'spread': '45.79', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Inflammatory Lesion Count to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDP-121 Lotion', 'description': 'IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'IDP-121 Vehicle Lotion', 'description': 'IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-53.4', 'spread': '45.44', 'groupId': 'OG000'}, {'value': '-41.5', 'spread': '45.68', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IDP-121 Lotion', 'description': 'IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.'}, {'id': 'FG001', 'title': 'IDP-121 Vehicle Lotion', 'description': 'IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '413'}, {'groupId': 'FG001', 'numSubjects': '407'}]}, {'type': 'Intent-to-treat (ITT) Population', 'comment': 'All randomized participants who received study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '413'}, {'groupId': 'FG001', 'numSubjects': '407'}]}, {'type': 'Safety Population', 'comment': 'All randomized participants with ≥1 confirmed dose of study drug and ≥1 post baseline evaluation.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '389'}, {'groupId': 'FG001', 'numSubjects': '398'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '342'}, {'groupId': 'FG001', 'numSubjects': '364'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '43'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Subject Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Parent or Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Noncompliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Worsening Condition', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant ran out of study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Participants were randomized in a 1:1 ratio to receive either IDP-121(tretinoin 0.05 percent \\[%\\]) Lotion or IDP-121 Vehicle Lotion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'BG000'}, {'value': '407', 'groupId': 'BG001'}, {'value': '820', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IDP-121 Lotion', 'description': 'IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.'}, {'id': 'BG001', 'title': 'IDP-121 Vehicle Lotion', 'description': 'IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.5', 'spread': '7.21', 'groupId': 'BG000'}, {'value': '20.7', 'spread': '7.63', 'groupId': 'BG001'}, {'value': '20.6', 'spread': '7.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '452', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '297', 'groupId': 'BG000'}, {'value': '311', 'groupId': 'BG001'}, {'value': '608', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Evaluator's Global Severity Score (EGSS)", 'classes': [{'title': '0 - Clear', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '1 - Almost Clear', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '2 - Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '3 - Moderate', 'categories': [{'measurements': [{'value': '369', 'groupId': 'BG000'}, {'value': '356', 'groupId': 'BG001'}, {'value': '725', 'groupId': 'BG002'}]}]}, {'title': '4 - Severe', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.', 'unitOfMeasure': 'Participants'}, {'title': 'Noninflammatory Lesion Count', 'classes': [{'categories': [{'measurements': [{'value': '46.1', 'spread': '19.25', 'groupId': 'BG000'}, {'value': '48.3', 'spread': '19.91', 'groupId': 'BG001'}, {'value': '47.2', 'spread': '19.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'lesion count', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Inflammatory Lesion Count', 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '5.42', 'groupId': 'BG000'}, {'value': '26.0', 'spread': '5.25', 'groupId': 'BG001'}, {'value': '26.2', 'spread': '5.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'lesion Count', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'ITT analysis set included all randomized participants who received study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-07', 'size': 7249897, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-02T06:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 820}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'dispFirstSubmitDate': '2017-12-12', 'completionDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-16', 'studyFirstSubmitDate': '2016-10-11', 'dispFirstSubmitQcDate': '2017-12-13', 'resultsFirstSubmitDate': '2019-12-02', 'studyFirstSubmitQcDate': '2016-11-11', 'dispFirstPostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-16', 'studyFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12', 'timeFrame': 'Baseline (Day 0), Week 12', 'description': 'Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.'}, {'measure': 'Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.'}, {'measure': 'Percentage of Participants With Treatment Success at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Noninflammatory Lesion Count to Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.'}, {'measure': 'Percent Change From Baseline in Inflammatory Lesion Count to Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne']}, 'referencesModule': {'references': [{'pmid': '32886337', 'type': 'DERIVED', 'citation': 'Tyring SK, Kircik L, Pariser DM, Woolery-Lloyd HC, Harper JC, Bhatt V, Pillai R, Guenin E. The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris. Am J Clin Dermatol. 2020 Dec;21(6):891-899. doi: 10.1007/s40257-020-00559-3.'}]}, 'descriptionModule': {'briefSummary': "The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score \\[EGSS\\] of 3 \\[moderate\\] or 4 \\[severe\\])."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Male or female at least 9 years of age and older.\n* Written and verbal informed consent must be obtained. Participants less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if participant reaches age of consent during the study they should be re-consented at the next study visit).\n* Participants must be willing to comply with study instructions and return to the study center for required visits. Participants under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.\n* If a cleanser, moisturizer or sunscreen is needed during the study, participants must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the participant wears makeup they must agree to use non-comedogenic makeup.\n\nKey Exclusion Criteria:\n\n* Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.\n* Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis.\n* Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.\n* Participants with a facial beard or mustache that could interfere with the study assessments.\n* History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any dosage form of tretinoin.\n* Participants who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.\n* Participants with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the participant's safety while participating in the study."}, 'identificationModule': {'nctId': 'NCT02965456', 'briefTitle': 'Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris', 'orgStudyIdInfo': {'id': 'V01-121A-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDP-121 Lotion', 'description': 'IDP-121 lotion (tretinoin 0.05 percent \\[%\\]) will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.', 'interventionNames': ['Drug: IDP 121 Lotion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'IDP-121 Vehicle Lotion', 'description': 'IDP-121 lotion vehicle will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.', 'interventionNames': ['Drug: IDP-121 Vehicle Lotion']}], 'interventions': [{'name': 'IDP 121 Lotion', 'type': 'DRUG', 'description': 'IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.', 'armGroupLabels': ['IDP-121 Lotion']}, {'name': 'IDP-121 Vehicle Lotion', 'type': 'DRUG', 'description': 'IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.', 'armGroupLabels': ['IDP-121 Vehicle Lotion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Valeant Site 21', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Valeant Site 34', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 25', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 18', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 09', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '92526', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 17', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'zip': '93035', 'city': 'Oxnard', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 26', 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 22', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 02', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 04', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 19', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33015', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Valeant Site 15', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Valeant Site 11', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33782', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Valeant Site 27', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '32771', 'city': 'Sanford', 'state': 'Florida', 'country': 'United States', 'facility': 'Valeant Site 31', 'geoPoint': {'lat': 28.80055, 'lon': -81.27312}}, {'zip': '33624', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Valeant Site 05', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Valeant Site 28', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60089', 'city': 'Buffalo Grove', 'state': 'Illinois', 'country': 'United States', 'facility': 'Valeant Site 16', 'geoPoint': {'lat': 42.15141, 'lon': -87.95979}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Valeant Site 06', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66215', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Valeant Site 12', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '70526', 'city': 'Crowley', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Valeant Site 32', 'geoPoint': {'lat': 30.21409, 'lon': -92.37458}}, {'zip': '48346', 'city': 'Clarkston', 'state': 'Michigan', 'country': 'United States', 'facility': 'Valeant Site 30', 'geoPoint': {'lat': 42.73586, 'lon': -83.41883}}, {'zip': '48302', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Valeant Site 03', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '89074', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Valeant Site 20', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Valeant Site 08', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27104', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Valeant Site 23', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '18201', 'city': 'Hazleton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Valeant Site 29', 'geoPoint': {'lat': 40.95842, 'lon': -75.97465}}, {'zip': '02919', 'city': 'Johnston', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Valeant Site 24', 'geoPoint': {'lat': 41.82186, 'lon': -71.50675}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Valeant Site 10', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77065', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Valeant Site 01', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77460', 'city': 'Port Arthur', 'state': 'Texas', 'country': 'United States', 'facility': 'Valeant Site 33', 'geoPoint': {'lat': 29.88519, 'lon': -93.94233}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Valeant Site 07', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Valeant Site 13', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78249', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Valeant Site 14', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Tim Theisen', 'role': 'STUDY_CHAIR', 'affiliation': 'TKL Research, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}