Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT00421993
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2007-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068801', 'term': 'Adapalene, Benzoyl Peroxide Drug Combination'}, {'id': 'D000068816', 'term': 'Adapalene'}, {'id': 'D001585', 'term': 'Benzoyl Peroxide'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.graeber@galderma.com', 'phone': '609-860-8201', 'title': 'Michael Graeber, MD', 'organization': 'Galderma'}, 'certainAgreement': {'otherDetails': 'Following the expiration of twenty-four (24) months after the completion of the Study, Investigator shall have the right to publish the results of the Study; provided, however that Sponsor shall have the right to review any proposed publication generated from the Study prior to publication or presentation. The Sponsor shall have the absolute right to refuse the publication altogether, to delay it or to amend its contents as it deems fit.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Adapalene/Benzoyl Peroxide Gel', 'description': 'Adapalene/Benzoyl Peroxide Topical Gel', 'otherNumAtRisk': 419, 'otherNumAffected': 90, 'seriousNumAtRisk': 419, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Adapalene Gel', 'description': 'Adapalene Topical Gel', 'otherNumAtRisk': 418, 'otherNumAffected': 60, 'seriousNumAtRisk': 418, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Benzoyl Peroxide Gel', 'description': 'Benzoyl Peroxide Topical Gel', 'otherNumAtRisk': 415, 'otherNumAffected': 35, 'seriousNumAtRisk': 415, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Gel Vehicle', 'description': 'Topical Gel Vehicle', 'otherNumAtRisk': 418, 'otherNumAffected': 22, 'seriousNumAtRisk': 418, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 419, 'numEvents': 93, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 418, 'numEvents': 61, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 415, 'numEvents': 37, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 418, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (6.1)'}], 'seriousEvents': [{'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (6.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (6.1)'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Scoliosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (6.1)'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (6.1)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'sourceVocabulary': 'MedDRA (6.1)'}, {'term': 'Schizoaffective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 415, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (6.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Success Rate on the Investigator's Global Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}, {'value': '415', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapalene/Benzoyl Peroxide Gel', 'description': 'Adapalene/Benzoyl Peroxide Topical Gel'}, {'id': 'OG001', 'title': 'Adapalene Gel', 'description': 'Adapalene Topical Gel'}, {'id': 'OG002', 'title': 'Benzoyl Peroxide Gel', 'description': 'Benzoyl Peroxide Topical Gel'}, {'id': 'OG003', 'title': 'Gel Vehicle', 'description': 'Topical Gel Vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'groupId': 'OG000'}, {'value': '21.8', 'groupId': 'OG001'}, {'value': '26.7', 'groupId': 'OG002'}, {'value': '17.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at week 12', 'description': 'Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT), last observation carried forward (LOCF).'}, {'type': 'PRIMARY', 'title': 'Changes in Inflammatory Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}, {'value': '415', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapalene/Benzoyl Peroxide Gel', 'description': 'Adapalene/Benzoyl Peroxide Topical Gel'}, {'id': 'OG001', 'title': 'Adapalene Gel', 'description': 'Adapalene Topical Gel'}, {'id': 'OG002', 'title': 'Benzoyl Peroxide Gel', 'description': 'Benzoyl Peroxide Topical Gel'}, {'id': 'OG003', 'title': 'Gel Vehicle', 'description': 'Topical Gel Vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '-18', 'groupId': 'OG000', 'lowerLimit': '-49', 'upperLimit': '50'}, {'value': '-15', 'groupId': 'OG001', 'lowerLimit': '-49', 'upperLimit': '50'}, {'value': '-16', 'groupId': 'OG002', 'lowerLimit': '-63', 'upperLimit': '38'}, {'value': '-12', 'groupId': 'OG003', 'lowerLimit': '-47', 'upperLimit': '95'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from Baseline to week 12', 'description': 'Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts', 'unitOfMeasure': 'Lesion count', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, LOCF'}, {'type': 'PRIMARY', 'title': 'Changes in Noninflammatory Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}, {'value': '415', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapalene/Benzoyl Peroxide Gel', 'description': 'Adapalene/Benzoyl Peroxide Topical Gel'}, {'id': 'OG001', 'title': 'Adapalene Gel', 'description': 'Adapalene Topical Gel'}, {'id': 'OG002', 'title': 'Benzoyl Peroxide Gel', 'description': 'Benzoyl Peroxide Topical Gel'}, {'id': 'OG003', 'title': 'Gel Vehicle', 'description': 'Topical Gel Vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '-28', 'groupId': 'OG000', 'lowerLimit': '-93', 'upperLimit': '108'}, {'value': '-24', 'groupId': 'OG001', 'lowerLimit': '-96', 'upperLimit': '44'}, {'value': '-23', 'groupId': 'OG002', 'lowerLimit': '-87', 'upperLimit': '61'}, {'value': '-18', 'groupId': 'OG003', 'lowerLimit': '-82', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from Baseline to week 12', 'description': 'Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count', 'unitOfMeasure': 'Lesion count', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, LOCF'}, {'type': 'SECONDARY', 'title': 'Percent Change in Inflammatory Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}, {'value': '415', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapalene/Benzoyl Peroxide Gel', 'description': 'Adapalene/Benzoyl Peroxide Topical Gel'}, {'id': 'OG001', 'title': 'Adapalene Gel', 'description': 'Adapalene Topical Gel'}, {'id': 'OG002', 'title': 'Benzoyl Peroxide Gel', 'description': 'Benzoyl Peroxide Topical Gel'}, {'id': 'OG003', 'title': 'Gel Vehicle', 'description': 'Topical Gel Vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '-61.7', 'spread': '33.9', 'groupId': 'OG000'}, {'value': '-50.1', 'spread': '39.4', 'groupId': 'OG001'}, {'value': '-52.2', 'spread': '39.4', 'groupId': 'OG002'}, {'value': '-40.8', 'spread': '41.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at week 12', 'description': 'Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, LOCF'}, {'type': 'SECONDARY', 'title': 'Percent Change in Noniflammatory Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}, {'value': '415', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapalene/Benzoyl Peroxide Gel', 'description': 'Adapalene/Benzoyl Peroxide Topical Gel'}, {'id': 'OG001', 'title': 'Adapalene Gel', 'description': 'Adapalene Topical Gel'}, {'id': 'OG002', 'title': 'Benzoyl Peroxide Gel', 'description': 'Benzoyl Peroxide Topical Gel'}, {'id': 'OG003', 'title': 'Gel Vehicle', 'description': 'Topical Gel Vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.6', 'spread': '35.3', 'groupId': 'OG000'}, {'value': '-46.0', 'spread': '33.7', 'groupId': 'OG001'}, {'value': '-44.1', 'spread': '37.3', 'groupId': 'OG002'}, {'value': '-32.3', 'spread': '39.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at week 12', 'description': 'Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, LOCF'}, {'type': 'SECONDARY', 'title': 'Percent Change in Total Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}, {'value': '415', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapalene/Benzoyl Peroxide Gel', 'description': 'Adapalene/Benzoyl Peroxide Topical Gel'}, {'id': 'OG001', 'title': 'Adapalene Gel', 'description': 'Adapalene Topical Gel'}, {'id': 'OG002', 'title': 'Benzoyl Peroxide Gel', 'description': 'Benzoyl Peroxide Topical Gel'}, {'id': 'OG003', 'title': 'Gel Vehicle', 'description': 'Topical Gel Vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '-57.7', 'spread': '31.9', 'groupId': 'OG000'}, {'value': '-47.5', 'spread': '31.3', 'groupId': 'OG001'}, {'value': '-47.2', 'spread': '32.7', 'groupId': 'OG002'}, {'value': '-35.2', 'spread': '36', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at week 12', 'description': 'Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, LOCF'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adapalene/Benzoyl Peroxide Gel', 'description': 'Adapalene/Benzoyl Peroxide Topical Gel'}, {'id': 'FG001', 'title': 'Adapalene Gel', 'description': 'Adapalene Topical Gel'}, {'id': 'FG002', 'title': 'Benzoyl Peroxide Gel', 'description': 'Benzoyl Peroxide Topical Gel'}, {'id': 'FG003', 'title': 'Gel Vehicle', 'description': 'Topical Gel Vehicle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '419'}, {'groupId': 'FG001', 'numSubjects': '418'}, {'groupId': 'FG002', 'numSubjects': '415'}, {'groupId': 'FG003', 'numSubjects': '418'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '366'}, {'groupId': 'FG001', 'numSubjects': '369'}, {'groupId': 'FG002', 'numSubjects': '363'}, {'groupId': 'FG003', 'numSubjects': '361'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Subject transportation issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment period: First Subject Enrolled October 2006, Last Subject Enrolled July 2007.\n\nTypes of locations: Dermatology Clinics, Dermatology Research Centers.', 'preAssignmentDetails': 'The specified washout period up to Baseline for TOPICAL facial treatments was 1 week (light therapy/exfoliation/blackhead removal) or 2 weeks (anti-inflammatory drugs/salicylic acid/steroids/antibiotics/laser) and for SYSTEMIC medications was 2 weeks (anti-inflammatory drugs), 4 Weeks (steroids/antibiotics), or 6 months (anti-acne/contraceptives).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'BG000'}, {'value': '418', 'groupId': 'BG001'}, {'value': '415', 'groupId': 'BG002'}, {'value': '418', 'groupId': 'BG003'}, {'value': '1670', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Adapalene/Benzoyl Peroxide Gel', 'description': 'Adapalene/Benzoyl Peroxide Topical Gel'}, {'id': 'BG001', 'title': 'Adapalene Gel', 'description': 'Adapalene Topical Gel'}, {'id': 'BG002', 'title': 'Benzoyl Peroxide Gel', 'description': 'Benzoyl Peroxide Topical Gel'}, {'id': 'BG003', 'title': 'Gel Vehicle', 'description': 'Topical Gel Vehicle'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '18.5', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '18.9', 'spread': '6.96', 'groupId': 'BG002'}, {'value': '19.2', 'spread': '7.23', 'groupId': 'BG003'}, {'value': '19', 'spread': '6.81', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '12-17 years', 'categories': [{'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '243', 'groupId': 'BG003'}, {'value': '961', 'groupId': 'BG004'}]}]}, {'title': 'Between 18 and 64 years', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}, {'value': '709', 'groupId': 'BG004'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '236', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}, {'value': '244', 'groupId': 'BG003'}, {'value': '939', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}, {'value': '174', 'groupId': 'BG003'}, {'value': '731', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}, {'value': '185', 'groupId': 'BG003'}, {'value': '734', 'groupId': 'BG004'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}, {'value': '403', 'groupId': 'BG004'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}, {'value': '533', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, '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': 1670}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2007-01-11', 'resultsFirstSubmitDate': '2009-01-15', 'studyFirstSubmitQcDate': '2007-01-11', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-03-10', 'studyFirstPostDateStruct': {'date': '2007-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Success Rate on the Investigator's Global Assessment", 'timeFrame': 'at week 12', 'description': 'Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)'}, {'measure': 'Changes in Inflammatory Lesion Counts', 'timeFrame': 'from Baseline to week 12', 'description': 'Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts'}, {'measure': 'Changes in Noninflammatory Lesion Counts', 'timeFrame': 'from Baseline to week 12', 'description': 'Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Inflammatory Lesion Counts', 'timeFrame': 'at week 12', 'description': 'Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100'}, {'measure': 'Percent Change in Noniflammatory Lesion Counts', 'timeFrame': 'at week 12', 'description': 'Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100'}, {'measure': 'Percent Change in Total Lesion Counts', 'timeFrame': 'at week 12', 'description': 'Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100'}]}, 'conditionsModule': {'keywords': ['Acne vulgaris', 'Adapalene', 'Benzoyl Peroxide'], 'conditions': ['Acne Vulgaris']}, 'referencesModule': {'references': [{'pmid': '12963896', 'type': 'BACKGROUND', 'citation': 'Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. doi: 10.1067/s0190-9622(03)01154-x.'}], 'seeAlsoLinks': [{'url': 'http://www.galderma.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.\n\nThe primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A clinical diagnosis of acne vulgaris with facial involvement.\n* A minimum of 20 but not more than 50 Inflammatory lesions\n* A minimum of 30 but not more than 100 Noninflammatory lesions\n* A score of 3 (Moderate) on the Investigator's Global Assessment Scale.\n\nExclusion Criteria:\n\n* More than one acne nodule or any acne cyst.\n* Acne conglobata, acne fulminans, secondary acne, or severe acne.\n* Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.\n* Underlying diseases that require the use of interfering topical or systemic therapy.\n* Use of prohibited medications prior to the study unless appropriate washout period is documented\n* Use of hormonal contraceptives solely for control of acne"}, 'identificationModule': {'nctId': 'NCT00421993', 'briefTitle': 'A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris', 'orgStudyIdInfo': {'id': 'RD.06.SPR.18088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Adapalene/Benzoyl Peroxide Topical Gel', 'interventionNames': ['Drug: Adapalene/Benzoyl Peroxide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Adapalene Topical Gel', 'interventionNames': ['Drug: Adapalene']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Benzoyl Peroxide Topical Gel', 'interventionNames': ['Drug: Benzoyl Peroxide']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Topical Gel Vehicle', 'interventionNames': ['Drug: Topical Gel Vehicle']}], 'interventions': [{'name': 'Adapalene/Benzoyl Peroxide', 'type': 'DRUG', 'description': 'Topical Gel, One application daily in the evening for 12 weeks', 'armGroupLabels': ['1']}, {'name': 'Adapalene', 'type': 'DRUG', 'description': 'Topical Gel,One application daily in the evening for 12 weeks', 'armGroupLabels': ['2']}, {'name': 'Benzoyl Peroxide', 'type': 'DRUG', 'description': 'Topical Gel, one application daily in the evening for 12 weeks', 'armGroupLabels': ['3']}, {'name': 'Topical Gel Vehicle', 'type': 'DRUG', 'description': 'Topical Gel Vehicle,one application daily in the evening for 12 weeks', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Medical Affliated Research Center', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Dermatology Research of Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Associates in research, Inc.', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92697-1385', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90292', 'city': 'Marina del Rey', 'state': 'California', 'country': 'United States', 'facility': 'Marcia J. 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