Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT02608450
Status:
COMPLETED
Last Update Posted:
2020-11-20
First Post:
2015-11-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)
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': 'C496269', 'term': 'Clascoterone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'r&d@cassiopea.com', 'phone': '+39 02 868 911 24', 'title': 'Cassiopea R&D', 'organization': 'Cassiopea SPA'}, 'certainAgreement': {'otherDetails': 'The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 18 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 60 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.', 'description': 'The Safety population was used for all analyses which comprised of all participants enrolled in the study and applied at least on dose of the test article.', 'eventGroups': [{'id': 'EG000', 'title': 'CB-03-01 Cream', 'description': 'CB-03-01 cream, 1% applied twice daily for 12 weeks\n\nCortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.', 'otherNumAtRisk': 353, 'deathsNumAtRisk': 353, 'otherNumAffected': 9, 'seriousNumAtRisk': 353, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle Cream', 'description': 'Vehicle cream applied twice daily for 12 weeks\n\nVehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.', 'otherNumAtRisk': 355, 'deathsNumAtRisk': 355, 'otherNumAffected': 18, 'seriousNumAtRisk': 355, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Application pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'notes': 'The SAE was deemed not related to test article.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}], 'frequencyThreshold': '0.6'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CB-03-01 Cream', 'description': 'CB-03-01 cream, 1% applied twice daily for 12 weeks\n\nCortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.'}, {'id': 'OG001', 'title': 'Vehicle Cream', 'description': 'Vehicle cream applied twice daily for 12 weeks\n\nVehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}, {'value': '9.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Percentage of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population included all randomized subjects.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Non-inflammatory Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CB-03-01 Cream', 'description': 'CB-03-01 cream, 1% applied twice daily for 12 weeks\n\nCortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.'}, {'id': 'OG001', 'title': 'Vehicle Cream', 'description': 'Vehicle cream applied twice daily for 12 weeks\n\nVehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.4', 'groupId': 'OG000', 'lowerLimit': '-22.6', 'upperLimit': '-16.7'}, {'value': '-13.0', 'groupId': 'OG001', 'lowerLimit': '-15.7', 'upperLimit': '-10.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.', 'unitOfMeasure': 'Non-inflammatory Lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Inflammatory Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CB-03-01 Cream', 'description': 'CB-03-01 cream, 1% applied twice daily for 12 weeks\n\nCortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.'}, {'id': 'OG001', 'title': 'Vehicle Cream', 'description': 'Vehicle cream applied twice daily for 12 weeks\n\nVehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.3', 'groupId': 'OG000', 'lowerLimit': '-21.1', 'upperLimit': '-17.5'}, {'value': '-15.5', 'groupId': 'OG001', 'lowerLimit': '-17.3', 'upperLimit': '-13.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.', 'unitOfMeasure': 'Inflammatory Lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CB-03-01 Cream', 'description': 'CB-03-01 cream, 1% applied twice daily for 12 weeks\n\nCortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.'}, {'id': 'OG001', 'title': 'Vehicle Cream', 'description': 'Vehicle cream applied twice daily for 12 weeks\n\nVehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.'}], 'classes': [{'categories': [{'measurements': [{'value': '-39.1', 'groupId': 'OG000', 'lowerLimit': '-43.0', 'upperLimit': '-35.1'}, {'value': '-28.8', 'groupId': 'OG001', 'lowerLimit': '-32.6', 'upperLimit': '-24.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Absolute change from Baseline in total lesions counts in each treatment group at Week 12.', 'unitOfMeasure': 'Total lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CB-03-01 Cream', 'description': 'CB-03-01 cream, 1% applied twice daily for 12 weeks\n\nCortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.'}, {'id': 'OG001', 'title': 'Vehicle Cream', 'description': 'Vehicle cream applied twice daily for 12 weeks\n\nVehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.'}], 'classes': [{'categories': [{'measurements': [{'value': '-37.0', 'groupId': 'OG000', 'lowerLimit': '-40.9', 'upperLimit': '-33.2'}, {'value': '-28.4', 'groupId': 'OG001', 'lowerLimit': '-32.3', 'upperLimit': '-24.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Percent change from Baseline in total lesions counts in each treatment group at Week 12.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-inflammatory Lesion (NIL) Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CB-03-01 Cream', 'description': 'CB-03-01 cream, 1% applied twice daily for 12 weeks\n\nCortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.'}, {'id': 'OG001', 'title': 'Vehicle Cream', 'description': 'Vehicle cream applied twice daily for 12 weeks\n\nVehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.6', 'groupId': 'OG000', 'lowerLimit': '-35.6', 'upperLimit': '-25.7'}, {'value': '-21.6', 'groupId': 'OG001', 'lowerLimit': '-26.4', 'upperLimit': '-16.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Inflammatory Lesion (IL) Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CB-03-01 Cream', 'description': 'CB-03-01 cream, 1% applied twice daily for 12 weeks\n\nCortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.'}, {'id': 'OG001', 'title': 'Vehicle Cream', 'description': 'Vehicle cream applied twice daily for 12 weeks\n\nVehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.'}], 'classes': [{'categories': [{'measurements': [{'value': '-44.8', 'groupId': 'OG000', 'lowerLimit': '-49.0', 'upperLimit': '-40.5'}, {'value': '-36.5', 'groupId': 'OG001', 'lowerLimit': '-40.8', 'upperLimit': '-32.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Local Site Reactions', 'timeFrame': 'Baseline, Weeks 4, 8, and 12', 'description': 'Local Site Reactions (LSRs) including telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus scored by frequency and severity at every visit (Baseline, Weeks 4, 8, and 12).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CB-03-01 Cream', 'description': 'CB-03-01 cream, 1% applied twice daily for 12 weeks\n\nCortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.'}, {'id': 'FG001', 'title': 'Vehicle Cream', 'description': 'Vehicle cream applied twice daily for 12 weeks\n\nVehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '353'}, {'groupId': 'FG001', 'numSubjects': '355'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '287'}, {'groupId': 'FG001', 'numSubjects': '290'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '65'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by parent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Noncompliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Multiple reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'BG000'}, {'value': '355', 'groupId': 'BG001'}, {'value': '708', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CB-03-01 Cream', 'description': 'CB-03-01 cream, 1% applied twice daily for 12 weeks\n\nCortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.'}, {'id': 'BG001', 'title': 'Vehicle Cream', 'description': 'Vehicle cream applied twice daily for 12 weeks\n\nVehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '19.9', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '19.9', 'spread': '6.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '436', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '534', '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': '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': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '298', 'groupId': 'BG000'}, {'value': '297', 'groupId': 'BG001'}, {'value': '595', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline IGA', 'classes': [{'categories': [{'title': '0 - Clear', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '1 - Almost Clear', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '2- Mild', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '3 - Moderate', 'measurements': [{'value': '292', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '583', 'groupId': 'BG002'}]}, {'title': '4 - Severe', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Investigator's Global Assessment (IGA)", 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Acne Lesion Counts', 'classes': [{'title': 'Non-inflammatory lesions', 'categories': [{'measurements': [{'value': '59.1', 'spread': '22.2', 'groupId': 'BG000'}, {'value': '60.7', 'spread': '22.1', 'groupId': 'BG001'}, {'value': '59.9', 'spread': '22.1', 'groupId': 'BG002'}]}]}, {'title': 'Inflammatory lesions', 'categories': [{'measurements': [{'value': '42.4', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '42.9', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '42.7', 'spread': '12.1', 'groupId': 'BG002'}]}]}, {'title': 'Total Lesion Count', 'categories': [{'measurements': [{'value': '101.5', 'spread': '25.1', 'groupId': 'BG000'}, {'value': '103.6', 'spread': '26.1', 'groupId': 'BG001'}, {'value': '102.6', 'spread': '25.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Lesions', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Number of participants is based on the Intent to treat dataset.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-08-06', 'size': 1100051, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-23T13:16', 'hasProtocol': True}, {'date': '2018-05-30', 'size': 1369029, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-23T13:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 708}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'dispFirstSubmitDate': '2019-06-07', 'completionDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2015-11-17', 'dispFirstSubmitQcDate': '2019-06-07', 'resultsFirstSubmitDate': '2020-09-23', 'studyFirstSubmitQcDate': '2015-11-17', 'dispFirstPostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-29', 'studyFirstPostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Local Site Reactions', 'timeFrame': 'Baseline, Weeks 4, 8, and 12', 'description': 'Local Site Reactions (LSRs) including telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus scored by frequency and severity at every visit (Baseline, Weeks 4, 8, and 12).'}], 'primaryOutcomes': [{'measure': "Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)", 'timeFrame': 'Week 12', 'description': 'Percentage of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.'}, {'measure': 'Change From Baseline in Non-inflammatory Lesion Counts', 'timeFrame': 'Baseline and Week 12', 'description': 'Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.'}, {'measure': 'Change From Baseline in Inflammatory Lesion Counts', 'timeFrame': 'Baseline and Week 12', 'description': 'Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Total Lesion Counts', 'timeFrame': 'Baseline and Week 12', 'description': 'Absolute change from Baseline in total lesions counts in each treatment group at Week 12.'}, {'measure': 'Percent Change From Baseline in Total Lesion Counts', 'timeFrame': 'Baseline and Week 12', 'description': 'Percent change from Baseline in total lesions counts in each treatment group at Week 12.'}, {'measure': 'Percent Change From Baseline in Non-inflammatory Lesion (NIL) Counts', 'timeFrame': 'Baseline and Week 12', 'description': 'Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.'}, {'measure': 'Percent Change From Baseline in Inflammatory Lesion (IL) Counts', 'timeFrame': 'Baseline and Week 12', 'description': 'Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acne', 'clascoterone', 'anti-androgen'], 'conditions': ['Acne Vulgaris']}, 'referencesModule': {'references': [{'pmid': '36745367', 'type': 'DERIVED', 'citation': 'Hebert A, Eichenfield L, Thiboutot D, Stein Gold L, Vassileva S, Mihaylova Y, Cartwright M, Moro L, Fragasso E, Han J, Squittieri N, Mazzetti A. Efficacy and Safety of 1% Clascoterone Cream in Patients Aged > 12 Years With Acne Vulgaris. J Drugs Dermatol. 2023 Feb 1;22(2):174-181. doi: 10.36849/JDD.7000.'}, {'pmid': '34607697', 'type': 'DERIVED', 'citation': 'Piszczatoski CR, Powell J. Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years. Clin Ther. 2021 Oct;43(10):1638-1644. doi: 10.1016/j.clinthera.2021.08.007. Epub 2021 Oct 2.'}, {'pmid': '32320027', 'type': 'DERIVED', 'citation': 'Hebert A, Thiboutot D, Stein Gold L, Cartwright M, Gerloni M, Fragasso E, Mazzetti A. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Jun 1;156(6):621-630. doi: 10.1001/jamadermatol.2020.0465.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is male or non-pregnant female, 9 years of age or older. Females must be post-menopausal, surgically sterile, or using highly effective birth control methods. Women of child-bearing potential must have a negative urine pregnancy test (UPT) at the Screening/Baseline Visit.\n2. Subject has provided written and verbal informed consent/assent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing.\n3. Subject has an Investigator's Global Assessment (IGA) score of 3 (moderate) or 4 (severe) \\[0 (clear) to 4 (severe) scale\\].\n4. Subject has facial acne vulgaris with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones).\n5. Subject and parent/guardian (if applicable) are willing to comply with study instructions and return to the clinic for required visits.\n6. Subject has used the same type and brand of make-up, other facial products (exclusive of RX/OTC acne cleansers) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one (1) month prior to the Baseline Visit and agrees to continue his/her other general skin and hair care products and regimen for the entire study.\n\nExclusion Criteria:\n\n1. Subject is pregnant, lactating, or is planning to become pregnant during the study.\n2. Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.\n3. Subject has greater than two (2) facial nodules.\n4. Subject has nodulocystic acne.\n5. Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.\n6. Subject is currently enrolled in an investigational drug or device study.\n7. Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).\n8. Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.\n9. Subject and parent/guardian (if applicable) are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.\n10. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.\n11. Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.\n12. Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.\n13. Subject has used any of the prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented.\n14. Subject has used used any of the prohibited systemic anti-acne medications prior to the study unless appropriate washout period is documented."}, 'identificationModule': {'nctId': 'NCT02608450', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cassiopea SpA'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris', 'orgStudyIdInfo': {'id': 'CB-03-01/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CB-03-01 cream', 'description': 'CB-03-01 cream, 1% applied twice daily for 12 weeks', 'interventionNames': ['Drug: CB-03-01 cream, 1%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle cream', 'description': 'Vehicle cream applied twice daily for 12 weeks', 'interventionNames': ['Drug: Vehicle cream']}], 'interventions': [{'name': 'CB-03-01 cream, 1%', 'type': 'DRUG', 'otherNames': ['cortexolone 17α-propionate', 'clascoterone (USAN, INN)'], 'description': 'CB-03-01 (cortexolone 17α-propionate) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.', 'armGroupLabels': ['CB-03-01 cream']}, {'name': 'Vehicle cream', 'type': 'DRUG', 'description': 'Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.', 'armGroupLabels': ['Vehicle cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Gary M. 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