Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-03-01 @ 6:27 AM
Study NCT ID:
NCT01880320
Status:
COMPLETED
Last Update Posted:
2018-06-28
First Post:
2013-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia']}, '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': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@galderma.com', 'phone': '00 33 4 93 95 70 70', 'title': 'Galderma CPM', 'organization': 'Galderma R&D'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CD0271 0.3% /CD1579 2.5% Gel', 'description': 'Active arm\n\nCD0271 0.3% / CD1579 2.5%', 'otherNumAtRisk': 217, 'otherNumAffected': 34, 'seriousNumAtRisk': 217, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CD0271 0.1% / CD1579 2.5%', 'description': 'Comparator arm\n\nCD0271 0.1% / CD1579 2.5%', 'otherNumAtRisk': 217, 'otherNumAffected': 23, 'seriousNumAtRisk': 217, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Topical Gel Vehicle', 'description': 'Placebo arm\n\nTopical Gel Vehicle', 'otherNumAtRisk': 69, 'otherNumAffected': 13, 'seriousNumAtRisk': 69, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Infleunza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Rhinitis seasonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}], 'seriousEvents': [{'term': 'Generalized Anxiety Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CD0271 0.3% /CD1579 2.5% Gel', 'description': 'Active arm\n\nCD0271 0.3% / CD1579 2.5%'}, {'id': 'OG001', 'title': 'CD0271 0.1% / CD1579 2.5%', 'description': 'Comparator arm\n\nCD0271 0.1% / CD1579 2.5%'}, {'id': 'OG002', 'title': 'Topical Gel Vehicle', 'description': 'Placebo arm\n\nTopical Gel Vehicle'}], 'classes': [{'title': 'All subjects (MI: Multiple Imputation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.7', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}, {'value': '11.0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline IGA=Severe (4) (MI: Multiple Imputation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000'}, {'value': '20.5', 'groupId': 'OG001'}, {'value': '11.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA).\n\nSuccess rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT): All subjects who were randomized. Baseline IGA Severe population: All randomized subjects who had IGA=4 at baseline.'}, {'type': 'PRIMARY', 'title': 'Changes From Baseline in Inflammatory Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CD0271 0.3% /CD1579 2.5% Gel', 'description': 'Active arm\n\nCD0271 0.3% / CD1579 2.5%'}, {'id': 'OG001', 'title': 'CD0271 0.1% / CD1579 2.5%', 'description': 'Comparator arm\n\nCD0271 0.1% / CD1579 2.5%'}, {'id': 'OG002', 'title': 'Topical Gel Vehicle', 'description': 'Placebo arm\n\nTopical Gel Vehicle'}], 'classes': [{'title': 'All Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-27.04', 'spread': '0.846', 'groupId': 'OG000'}, {'value': '-26.72', 'spread': '0.822', 'groupId': 'OG001'}, {'value': '-14.40', 'spread': '1.460', 'groupId': 'OG002'}]}]}, {'title': 'Baseline IGA = Severe (4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-35.17', 'spread': '1.407', 'groupId': 'OG000'}, {'value': '-31.92', 'spread': '1.320', 'groupId': 'OG001'}, {'value': '-15.46', 'spread': '2.297', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline - Week12', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population, Multiple imputation'}, {'type': 'PRIMARY', 'title': 'Changes From Baseline in Non-Inflammatory Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CD0271 0.3% /CD1579 2.5% Gel', 'description': 'Active arm\n\nCD0271 0.3% / CD1579 2.5%'}, {'id': 'OG001', 'title': 'CD0271 0.1% / CD1579 2.5%', 'description': 'Comparator arm\n\nCD0271 0.1% / CD1579 2.5%'}, {'id': 'OG002', 'title': 'Topical Gel Vehicle', 'description': 'Placebo arm\n\nTopical Gel Vehicle'}], 'classes': [{'title': 'All Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-40.18', 'spread': '1.332', 'groupId': 'OG000'}, {'value': '-39.00', 'spread': '1.277', 'groupId': 'OG001'}, {'value': '-18.47', 'spread': '2.270', 'groupId': 'OG002'}]}]}, {'title': 'Baseline IGA = Severe (4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-45.61', 'spread': '2.058', 'groupId': 'OG000'}, {'value': '-43.10', 'spread': '1.847', 'groupId': 'OG001'}, {'value': '-17.25', 'spread': '3.337', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline - Week 12', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population, Multiple Imputation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CD0271 0.3% /CD1579 2.5% Gel', 'description': 'Active arm\n\nCD0271 0.3% / CD1579 2.5%'}, {'id': 'FG001', 'title': 'CD0271 0.1% / CD1579 2.5%', 'description': 'Comparator arm\n\nCD0271 0.1% / CD1579 2.5%'}, {'id': 'FG002', 'title': 'Topical Gel Vehicle', 'description': 'Placebo arm\n\nTopical Gel Vehicle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '217'}, {'groupId': 'FG002', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '192'}, {'groupId': 'FG002', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '503', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CD0271 0.3% /CD1579 2.5% Gel', 'description': 'Active arm\n\nCD0271 0.3% / CD1579 2.5%'}, {'id': 'BG001', 'title': 'CD0271 0.1% / CD1579 2.5%', 'description': 'Comparator arm\n\nCD0271 0.1% / CD1579 2.5%'}, {'id': 'BG002', 'title': 'Topical Gel Vehicle', 'description': 'Placebo arm\n\nTopical Gel Vehicle'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '303', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '200', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'spread': '7.59', 'groupId': 'BG000'}, {'value': '19.4', 'spread': '6.75', 'groupId': 'BG001'}, {'value': '18.5', 'spread': '5.72', 'groupId': 'BG002'}, {'value': '19.6', 'spread': '7.01', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '263', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '465', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Investigator Global Assessment (IGA)', 'classes': [{'title': 'Baseline IGA = Moderate (3)', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '251', 'groupId': 'BG003'}]}]}, {'title': 'Baseline IGA = Severe (4)', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '252', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 503}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-28', 'studyFirstSubmitDate': '2013-06-14', 'resultsFirstSubmitDate': '2016-03-07', 'studyFirstSubmitQcDate': '2013-06-17', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-25', 'studyFirstPostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success Rate', 'timeFrame': 'Week 12', 'description': "Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA).\n\nSuccess rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets."}, {'measure': 'Changes From Baseline in Inflammatory Lesion Counts', 'timeFrame': 'Baseline - Week12'}, {'measure': 'Changes From Baseline in Non-Inflammatory Lesion Counts', 'timeFrame': 'Baseline - Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'referencesModule': {'references': [{'pmid': '28686776', 'type': 'DERIVED', 'citation': 'Stein Gold L, Werschler WP, Mohawk J. Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: Effective Acne Therapy Regardless of Age or Gender. J Drugs Dermatol. 2017 Jun 1;16(6):582-589.'}, {'pmid': '28686775', 'type': 'DERIVED', 'citation': 'Alexis AF, Cook-Bolden FE, York JP. Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: A Safe and Effective Acne Therapy in All Skin Phototypes. J Drugs Dermatol. 2017 Jun 1;16(6):574-581.'}, {'pmid': '26945741', 'type': 'DERIVED', 'citation': 'Stein Gold L, Weiss J, Rueda MJ, Liu H, Tanghetti E. Moderate and Severe Inflammatory Acne Vulgaris Effectively Treated with Single-Agent Therapy by a New Fixed-Dose Combination Adapalene 0.3 %/Benzoyl Peroxide 2.5 % Gel: A Randomized, Double-Blind, Parallel-Group, Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):293-303. doi: 10.1007/s40257-016-0178-4.'}]}, 'descriptionModule': {'briefSummary': 'The study hypothesis are based on the assumption that :\n\n* CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects\n* CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female, who is 12 years of age or older at Screening visit.\n2. Clinical diagnosis of acne vulgaris with facial involvement.\n3. An IGA of Moderate (3) or Severe (4) at Baseline visit.\n4. A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit.\n5. A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at Baseline visit.\n\nExclusion Criteria:\n\n1. More than 2 acne nodules on the face at Baseline visit.\n2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.\n3. Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This includes clinically significant abnormal findings, uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.\n4. The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit\n5. The subject is unwilling to refrain from use of prohibited medication during the clinical trial.\n6. Use of hormonal contraceptives solely for control of acne."}, 'identificationModule': {'nctId': 'NCT01880320', 'briefTitle': 'Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Parallel-group Vehicle and Active Controlled Study to Compare the Efficacy and Safety of CD0271 0.3% / CD1579 2.5% Topical Gel Versus Topical Gel Vehicle in Subjects With Acne Vulgaris', 'orgStudyIdInfo': {'id': 'RD.06.SPR.18240'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD0271 0.3% /CD1579 2.5% Gel', 'description': 'active arm', 'interventionNames': ['Drug: CD0271 0.3% / CD1579 2.5%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CD0271 0.1% / CD1579 2.5%', 'description': 'Comparator arm', 'interventionNames': ['Drug: CD0271 0.1% / CD1579 2.5%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 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