Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-11 @ 5:35 AM
Study NCT ID:
NCT03168334
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2017-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}}}}, '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': '510-259-5284', 'title': 'Study Director', 'organization': 'Bausch Health Americas, Inc'}, 'certainAgreement': {'otherDetails': 'Please contact Sponsor directly for additional information.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post- baseline safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'IDP-123 Lotion', 'description': 'IDP-123 (Tazarotene 0.045%) Lotion', 'otherNumAtRisk': 387, 'deathsNumAtRisk': 387, 'otherNumAffected': 43, 'seriousNumAtRisk': 387, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vehicle Lotion', 'description': 'IDP-123 Vehicle Lotion', 'otherNumAtRisk': 392, 'deathsNumAtRisk': 392, 'otherNumAffected': 17, 'seriousNumAtRisk': 392, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Application Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change in Mean Lesion Counts at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDP-123 Lotion', 'description': 'IDP-123 (Tazarotene 0.045%) Lotion'}, {'id': 'OG001', 'title': 'Vehicle Lotion', 'description': 'IDP-123 Vehicle Lotion'}], 'classes': [{'title': 'Non-inflammatory lesions', 'categories': [{'measurements': [{'value': '-24.6', 'spread': '15.33', 'groupId': 'OG000'}, {'value': '-16.6', 'spread': '15.48', 'groupId': 'OG001'}]}]}, {'title': 'Inflammatory lesions', 'categories': [{'measurements': [{'value': '-16.7', 'spread': '9.49', 'groupId': 'OG000'}, {'value': '-13.4', 'spread': '9.37', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.', 'unitOfMeasure': 'lesion counts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator\'s Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDP-123 Lotion', 'description': 'IDP-123 (Tazarotene 0.045%) Lotion'}, {'id': 'OG001', 'title': 'Vehicle Lotion', 'description': 'IDP-123 Vehicle Lotion'}], 'classes': [{'categories': [{'measurements': [{'value': '29.6', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12', 'description': "Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Mean Lesion Counts at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDP-123 Lotion', 'description': 'IDP-123 (Tazarotene 0.045%) Lotion'}, {'id': 'OG001', 'title': 'Vehicle Lotion', 'description': 'IDP-123 Vehicle Lotion'}], 'classes': [{'title': 'Non-inflammatory lesions', 'categories': [{'measurements': [{'value': '-60.00', 'spread': '34.680', 'groupId': 'OG000'}, {'value': '-41.58', 'spread': '35.239', 'groupId': 'OG001'}]}]}, {'title': 'Inflammatory lesions', 'categories': [{'measurements': [{'value': '-59.50', 'spread': '33.382', 'groupId': 'OG000'}, {'value': '-48.95', 'spread': '32.898', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDP-123 Lotion', 'description': 'IDP-123 (Tazarotene 0.045%) Lotion'}, {'id': 'OG001', 'title': 'Vehicle Lotion', 'description': 'IDP-123 Vehicle Lotion'}], 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000'}, {'value': '20.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12', 'description': "Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Mean Lesion Counts at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDP-123 Lotion', 'description': 'IDP-123 (Tazarotene 0.045%) Lotion'}, {'id': 'OG001', 'title': 'Vehicle Lotion', 'description': 'IDP-123 Vehicle Lotion'}], 'classes': [{'title': 'Non-inflammatory lesions', 'categories': [{'measurements': [{'value': '-48.45', 'spread': '36.497', 'groupId': 'OG000'}, {'value': '-30.92', 'spread': '36.772', 'groupId': 'OG001'}]}]}, {'title': 'Inflammatory lesions', 'categories': [{'measurements': [{'value': '-50.38', 'spread': '32.917', 'groupId': 'OG000'}, {'value': '-41.66', 'spread': '32.874', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 8', 'description': 'For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Mean Lesion Counts at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDP-123 Lotion', 'description': 'IDP-123 (Tazarotene 0.045%) Lotion'}, {'id': 'OG001', 'title': 'Vehicle Lotion', 'description': 'IDP-123 Vehicle Lotion'}], 'classes': [{'title': 'Non-inflammatory lesions', 'categories': [{'measurements': [{'value': '-35.03', 'spread': '32.776', 'groupId': 'OG000'}, {'value': '-24.12', 'spread': '33.040', 'groupId': 'OG001'}]}]}, {'title': 'Inflammatory lesions', 'categories': [{'measurements': [{'value': '-32.31', 'spread': '32.906', 'groupId': 'OG000'}, {'value': '-31.55', 'spread': '32.954', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 4', 'description': 'For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IDP-123 Lotion', 'description': 'IDP-123 (Tazarotene 0.045%) Lotion'}, {'id': 'FG001', 'title': 'Vehicle Lotion', 'description': 'IDP-123 Vehicle Lotion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '397'}, {'groupId': 'FG001', 'numSubjects': '404'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '345'}, {'groupId': 'FG001', 'numSubjects': '366'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '38'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'BG000'}, {'value': '404', 'groupId': 'BG001'}, {'value': '801', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IDP-123 Lotion', 'description': 'IDP-123 (Tazarotene 0.045%) Lotion'}, {'id': 'BG001', 'title': 'Vehicle Lotion', 'description': 'IDP-123 Vehicle Lotion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'spread': '6.48', 'groupId': 'BG000'}, {'value': '20.5', 'spread': '6.81', 'groupId': 'BG001'}, {'value': '20.3', 'spread': '6.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '513', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '298', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '601', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lesion counts', 'classes': [{'title': 'Non-inflammatory lesions', 'categories': [{'measurements': [{'value': '41.8', 'spread': '17.87', 'groupId': 'BG000'}, {'value': '40.6', 'spread': '16.31', 'groupId': 'BG001'}, {'value': '41.2', 'spread': '17.10', 'groupId': 'BG002'}]}]}, {'title': 'Inflammatory lesions', 'categories': [{'measurements': [{'value': '28.0', 'spread': '7.32', 'groupId': 'BG000'}, {'value': '27.9', 'spread': '7.10', 'groupId': 'BG001'}, {'value': '28.0', 'spread': '7.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.', 'unitOfMeasure': 'lesions', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Evaluator's Global Severity Score", 'classes': [{'categories': [{'title': 'Moderate', 'measurements': [{'value': '358', 'groupId': 'BG000'}, {'value': '357', 'groupId': 'BG001'}, {'value': '715', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.", 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-24', 'size': 1236935, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-15T12:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 801}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2021-03', 'dispFirstSubmitDate': '2019-03-08', 'completionDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-30', 'studyFirstSubmitDate': '2017-05-24', 'dispFirstSubmitQcDate': '2021-03-30', 'resultsFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2017-05-24', 'dispFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-30', 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change in Mean Lesion Counts at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.'}, {'measure': 'Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator\'s Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear"', 'timeFrame': 'Baseline to Week 12', 'description': "Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe."}], 'secondaryOutcomes': [{'measure': 'Percentage Change in Mean Lesion Counts at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.'}, {'measure': "Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)", 'timeFrame': 'Baseline to Week 12', 'description': "Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe."}, {'measure': 'Percentage Change in Mean Lesion Counts at Week 8', 'timeFrame': 'Baseline to Week 8', 'description': 'For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.'}, {'measure': 'Percentage Change in Mean Lesion Counts at Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion.', 'detailedDescription': 'This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123 Vehicle Lotion. To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female at least 9 years of age and older;\n2. Written and verbal informed consent must be obtained. Subjects 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 subject reaches age of consent during the study they should be re-consented at the next study visit);\n3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the baseline visit;\n4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;\n5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;\n6. Subjects with two or fewer facial nodules\n\nExclusion Criteria:\n\n1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;\n2. 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, gram-negative folliculitis, dermatitis, eczema;\n3. 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;\n4. Subjects with a facial beard or mustache that could interfere with the study assessments;\n5. Subjects with more than two (2) facial nodules;\n6. Evidence or history of cosmetic-related acne"}, 'identificationModule': {'nctId': 'NCT03168334', 'briefTitle': 'A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-123 Lotion and IDP-123 Vehicle Lotion in the Treatment of Acne Vulgaris', 'orgStudyIdInfo': {'id': 'V01-123A-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDP-123 Lotion', 'description': 'Tazarotene 0.045% Lotion', 'interventionNames': ['Drug: IDP-123 Lotion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'IDP-123 Vehicle Lotion', 'description': 'Vehicle Lotion', 'interventionNames': ['Drug: IDP-123 Vehicle Lotion']}], 'interventions': [{'name': 'IDP-123 Lotion', 'type': 'DRUG', 'otherNames': ['IDP-123'], 'description': 'Tazarotene 0.045% Lotion', 'armGroupLabels': ['IDP-123 Lotion']}, {'name': 'IDP-123 Vehicle Lotion', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'Vehicle Lotion', 'armGroupLabels': ['IDP-123 Vehicle Lotion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Valeant Site 41', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Valeant Site 22', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '92008', 'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 34', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 12', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '92123', 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