Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT03034460
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2016-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of CD5024 1% in Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Studies@galderma.com', 'phone': '817 961 5000', 'title': 'Clinical Operations', 'phoneExt': '+1', 'organization': 'Galderma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study up to follow up (Week 7)', 'eventGroups': [{'id': 'EG000', 'title': 'Group I: CD5024 Cream Versus Its Vehicle', 'description': 'Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 32, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group II: Epiduo Gel Versus Its Vehicle', 'description': 'Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 11, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Inflammatory Lesion Count (Papules and Pustules) at Day 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'units': 'One side of face', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CD5024 1% Cream', 'description': 'Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG001', 'title': 'CD5024 1% Cream Matched Placebo', 'description': 'Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG002', 'title': 'Adapalene Benzoyl Peroxyde', 'description': 'Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG003', 'title': 'Adapalene Benzoyl Peroxyde Matched Placebo', 'description': 'Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week\n\n1 to Week 5 and for 4 days during Week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '6.1', 'spread': '4.9', 'groupId': 'OG002'}, {'value': '9.4', 'spread': '5.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '= 0.158', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis was performed in participants applied CD5024 1% Cream on one side of face and CD5024 1% Cream Matched Placebo on other side of face for paired difference between Active - Vehicle (CD5024 1% Cream \\[n=48\\] versus CD5024 1% Cream Matched Placebo \\[n=48\\]).', 'statisticalMethod': 'Wilcoxon rank signed test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.002', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'This analysis was performed in participants applied Adapalene Benzoyl Peroxyde on one side of face and Adapalene Benzoyl Peroxyde Matched Placebo on the other side of face for paired difference between Active - Vehicle (Adapalene Benzoyl Peroxyde \\[n=22\\] versus Adapalene Benzoyl Peroxyde Matched Placebo \\[n=22\\]).', 'statisticalMethod': 'Wilcoxon rank signed test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 40', 'description': 'Inflammatory lesion count corresponded to the sum of papules and pustules.', 'unitOfMeasure': 'lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'One side of face', 'denomUnitsSelected': 'One side of face', 'populationDescription': 'This analysis was performed on ITT- last observation carried forward (LOCF) population. ITT-population included all participants who were randomized. Outcome measure data was summarized using the LOCF at Day 40. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.'}, {'type': 'SECONDARY', 'title': 'Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'units': 'One side of face', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CD5024 1% Cream', 'description': 'Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG001', 'title': 'CD5024 1% Cream Matched Placebo', 'description': 'Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG002', 'title': 'Adapalene Benzoyl Peroxyde', 'description': 'Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG003', 'title': 'Adapalene Benzoyl Peroxyde Matched Placebo', 'description': 'Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week\n\n1 to Week 5 and for 4 days during Week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '7.4', 'groupId': 'OG001'}, {'value': '17.6', 'spread': '8.6', 'groupId': 'OG002'}, {'value': '16.6', 'spread': '7.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1)', 'description': 'Inflammatory lesion count corresponded to the sum of papules and pustules.', 'unitOfMeasure': 'lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'One side of face', 'denomUnitsSelected': 'One side of face', 'populationDescription': 'This analysis was performed on ITT population. ITT population included all partcipants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.'}, {'type': 'SECONDARY', 'title': 'Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'units': 'One side of face', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CD5024 1% Cream', 'description': 'Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG001', 'title': 'CD5024 1% Cream Matched Placebo', 'description': 'Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG002', 'title': 'Adapalene Benzoyl Peroxyde', 'description': 'Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG003', 'title': 'Adapalene Benzoyl Peroxyde Matched Placebo', 'description': 'Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week\n\n1 to Week 5 and for 4 days during Week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'spread': '43.4', 'groupId': 'OG000'}, {'value': '44.4', 'spread': '32.3', 'groupId': 'OG001'}, {'value': '65.5', 'spread': '24.0', 'groupId': 'OG002'}, {'value': '42.5', 'spread': '30.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), and Day 40', 'description': 'Inflammatory lesion count corresponded to the sum of papules and pustules.', 'unitOfMeasure': 'percent reduction of lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'One side of face', 'denomUnitsSelected': 'One side of face', 'populationDescription': 'This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.'}, {'type': 'SECONDARY', 'title': 'Total Lesion Count at Baseline (Day 1) and Day 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'units': 'One side of face', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CD5024 1% Cream', 'description': 'Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG001', 'title': 'CD5024 1% Cream Matched Placebo', 'description': 'Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG002', 'title': 'Adapalene Benzoyl Peroxyde', 'description': 'Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG003', 'title': 'Adapalene Benzoyl Peroxyde Matched Placebo', 'description': 'Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week\n\n1 to Week 5 and for 4 days during Week 6.'}], 'classes': [{'title': 'Baseline (Day 1)', 'categories': [{'measurements': [{'value': '37.7', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '39.4', 'spread': '13.7', 'groupId': 'OG001'}, {'value': '37.3', 'spread': '20.2', 'groupId': 'OG002'}, {'value': '36.4', 'spread': '18.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 40', 'categories': [{'measurements': [{'value': '26.4', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '25.9', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '19.3', 'spread': '15.0', 'groupId': 'OG002'}, {'value': '25.5', 'spread': '17.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), and Day 40', 'description': 'Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.', 'unitOfMeasure': 'lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'One side of face', 'denomUnitsSelected': 'One side of face', 'populationDescription': 'This analysis was performed on ITT- last observation carried forward (LOCF) population. ITT population included all participants who were randomized. Outcome Measure data was summarized using the LOCF at Day 40. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.'}, {'type': 'SECONDARY', 'title': 'Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'units': 'One side of face', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CD5024 1% Cream', 'description': 'Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG001', 'title': 'CD5024 1% Cream Matched Placebo', 'description': 'Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG002', 'title': 'Adapalene Benzoyl Peroxyde', 'description': 'Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG003', 'title': 'Adapalene Benzoyl Peroxyde Matched Placebo', 'description': 'Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week\n\n1 to Week 5 and for 4 days during Week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.5', 'spread': '32.2', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '27.1', 'groupId': 'OG001'}, {'value': '50.2', 'spread': '27.2', 'groupId': 'OG002'}, {'value': '27.8', 'spread': '31.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), and Day 40', 'description': 'Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.', 'unitOfMeasure': 'percent reduction in total lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'One side of face', 'denomUnitsSelected': 'One side of face', 'populationDescription': 'This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.'}, {'type': 'SECONDARY', 'title': 'Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'units': 'One side of face', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CD5024 1% Cream', 'description': 'Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG001', 'title': 'CD5024 1% Cream Matched Placebo', 'description': 'Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG002', 'title': 'Adapalene Benzoyl Peroxyde', 'description': 'Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG003', 'title': 'Adapalene Benzoyl Peroxyde Matched Placebo', 'description': 'Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week\n\n1 to Week 5 and for 4 days during Week 6.'}], 'classes': [{'title': 'Baseline (Day 1)', 'categories': [{'measurements': [{'value': '21.1', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '21.8', 'spread': '10.7', 'groupId': 'OG001'}, {'value': '19.6', 'spread': '14.1', 'groupId': 'OG002'}, {'value': '19.6', 'spread': '13.6', 'groupId': 'OG003'}]}]}, {'title': 'Day 40', 'categories': [{'measurements': [{'value': '16.2', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '12.7', 'groupId': 'OG001'}, {'value': '13.0', 'spread': '12.0', 'groupId': 'OG002'}, {'value': '16.0', 'spread': '14.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), and Day 40', 'description': 'Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.', 'unitOfMeasure': 'lesion count', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'One side of face', 'denomUnitsSelected': 'One side of face', 'populationDescription': 'This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.'}, {'type': 'SECONDARY', 'title': 'Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'units': 'One side of face', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CD5024 1% Cream', 'description': 'Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG001', 'title': 'CD5024 1% Cream Matched Placebo', 'description': 'Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG002', 'title': 'Adapalene Benzoyl Peroxyde', 'description': 'Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG003', 'title': 'Adapalene Benzoyl Peroxyde Matched Placebo', 'description': 'Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week\n\n1 to Week 5 and for 4 days during Week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'spread': '39.4', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '42.0', 'groupId': 'OG001'}, {'value': '36.9', 'spread': '36.1', 'groupId': 'OG002'}, {'value': '11.7', 'spread': '48.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), and Day 40', 'description': 'Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.', 'unitOfMeasure': 'percent reduction of lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'One side of face', 'denomUnitsSelected': 'One side of face', 'populationDescription': 'This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.'}, {'type': 'SECONDARY', 'title': "Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40", 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I: CD5024 Cream Versus Its Vehicle', 'description': 'Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.'}, {'id': 'OG001', 'title': 'Group II: Epiduo Gel Versus Its Vehicle', 'description': 'Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.'}], 'classes': [{'title': 'Day 40 (Active much better than Vehicle)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Day 40 (Active better than Vehicle)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Day 40 (No clinical difference between Active and Vehicle)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Day 40 (Vehicle better than Active)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Day 40 (Vehicle much better than Active)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 40', 'description': 'The Investigator gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "This analysis was performed on ITT population. ITT population included all participants who were randomized. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': "Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40", 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I: CD5024 Cream Versus Its Vehicle', 'description': 'Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.'}, {'id': 'OG001', 'title': 'Group II: Epiduo Gel Versus Its Vehicle', 'description': 'Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.'}], 'classes': [{'title': 'Day 40 (Active much better than Vehicle)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 40 (Active better than Vehicle)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Day 40 (No clinical difference between Active and Vehicle)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Day 40 (Vehicle better than Active)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 40 (Vehicle much better than Active)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 40', 'description': 'The participants gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "This analysis was performed on ITT population. ITT population included all participants who were randomized. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this endpoint."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I: CD5024 Cream Versus Its Vehicle', 'description': 'Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.'}, {'id': 'OG001', 'title': 'Group II: Epiduo Gel Versus Its Vehicle', 'description': 'Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study up to follow up (Week 7)', 'description': 'AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "This analysis was performed on safety population. Safety population included participants in the ITT population who received at least 1 application of the investigational product. Number of participants with AE's were reported."}, {'type': 'SECONDARY', 'title': 'Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CD5024 1% Cream', 'description': 'Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG001', 'title': 'CD5024 1% Cream Matched Placebo', 'description': 'Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG002', 'title': 'Adapalene Benzoyl Peroxyde', 'description': 'Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.'}, {'id': 'OG003', 'title': 'Adapalene Benzoyl Peroxyde Matched Placebo', 'description': 'Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week\n\n1 to Week 5 and for 4 days during Week 6.'}], 'classes': [{'title': 'Face: Erythema: 0-None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Face: Erythema: 1-Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Face: Erythema: 2-Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Face: Scaling/Desquamation: 0-None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Face: Scaling/Desquamation: 1-Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Face: Scaling/Desquamation: 2- Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Face: Dryness: 0-None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Face: Dryness: 1-Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Face: Dryness: 2-Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Face: Stinging/Burning: 0-None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Face: Stinging/Burning: 1-Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Face: Stinging/Burning: 2-Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Ear: Erythema: 0-None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Ear: Erythema: 1-Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Ear: Erythema: 2-Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Ear: Scaling/Desquamation: 0-None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Ear: Scaling/Desquamation: 1-Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Ear: Scaling/Desquamation: 2-Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Ear: Dryness: 0-None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Ear: Dryness: 1-Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Ear: Dryness: 2-Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Ear: Stinging/Burning: 0-None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Ear: Stinging/Burning: 1-Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Ear: Stinging/Burning: 2-Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 up Follow up (Week 7)', 'description': 'Signs and symptoms of local cutaneous irritation(local tolerability \\[erythema, scaling, dryness, stinging/burning, pruritus\\]) were evaluated on all treated areas (face and behind ears if applicable) every day from Day 1 up to follow-up (Week 7) using a 4-point scale of None (0), Mild (1), Moderate (2), or Severe (3). Number of participants reported worst local tolerability score on treated areas from Day 1 to follow up (Week 7) was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included participants in the ITT population who received at least 1 application of the investigational product. Here 'n' (number analyzed) signifies number of participants who were evaluable for each specified category. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group I: CD5024 Cream Versus Its Vehicle', 'description': 'Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.'}, {'id': 'FG001', 'title': 'Group II: Epiduo Gel Versus Its Vehicle', 'description': 'Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at six centers in three countries (Germany, France, Canada) between 25 April 2016 (first participant screened) to 02 November 2016 (last participant completed).', 'preAssignmentDetails': 'A total of 70 participants were randomized, of which 64 participants completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group I: CD5024 Cream Versus Its Vehicle', 'description': 'Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.'}, {'id': 'BG001', 'title': 'Group II: Epiduo Gel Versus Its Vehicle', 'description': 'Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '23.4', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '23.3', 'spread': '4.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of inflammatory lesions', 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '34.2', 'spread': '15.1', 'groupId': 'BG001'}, {'value': '34.0', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Lesion Count', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2016-11-21', 'resultsFirstSubmitDate': '2020-11-16', 'studyFirstSubmitQcDate': '2017-01-25', 'lastUpdatePostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-16', 'studyFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammatory Lesion Count (Papules and Pustules) at Day 40', 'timeFrame': 'Day 40', 'description': 'Inflammatory lesion count corresponded to the sum of papules and pustules.'}], 'secondaryOutcomes': [{'measure': 'Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)', 'timeFrame': 'Baseline (Day 1)', 'description': 'Inflammatory lesion count corresponded to the sum of papules and pustules.'}, {'measure': 'Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40', 'timeFrame': 'Baseline (Day 1), and Day 40', 'description': 'Inflammatory lesion count corresponded to the sum of papules and pustules.'}, {'measure': 'Total Lesion Count at Baseline (Day 1) and Day 40', 'timeFrame': 'Baseline (Day 1), and Day 40', 'description': 'Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.'}, {'measure': 'Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40', 'timeFrame': 'Baseline (Day 1), and Day 40', 'description': 'Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.'}, {'measure': 'Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40', 'timeFrame': 'Baseline (Day 1), and Day 40', 'description': 'Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.'}, {'measure': 'Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40', 'timeFrame': 'Baseline (Day 1), and Day 40', 'description': 'Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.'}, {'measure': "Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40", 'timeFrame': 'Day 40', 'description': 'The Investigator gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.'}, {'measure': "Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40", 'timeFrame': 'Day 40', 'description': 'The participants gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From start of study up to follow up (Week 7)', 'description': 'AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.'}, {'measure': 'Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)', 'timeFrame': 'From Day 1 up Follow up (Week 7)', 'description': 'Signs and symptoms of local cutaneous irritation(local tolerability \\[erythema, scaling, dryness, stinging/burning, pruritus\\]) were evaluated on all treated areas (face and behind ears if applicable) every day from Day 1 up to follow-up (Week 7) using a 4-point scale of None (0), Mild (1), Moderate (2), or Severe (3). Number of participants reported worst local tolerability score on treated areas from Day 1 to follow up (Week 7) was reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne']}, 'descriptionModule': {'briefSummary': 'Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using intra-individual comparison involving subjects with acne vulgaris on face to evaluate the efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.', 'detailedDescription': 'Study drugs application will be performed once daily, 5 days a week during 6 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The subject is a male or a female aged from 18 to 35 years old at screening visit.\n2. The subject has a medical diagnosis of acne vulgaris :\n\n 2.1 at least 20 (twenty) inflammatory lesions and a maximum of 100 (one hundred) non-inflammatory lesions (nose is excluded for the lesion count) at Baseline\n\n 2.2 symmetry of the lesions: No more than twice as many acne lesions on one side as compared to the other side at Baseline\n3. If the subject is a female of childbearing potential, she must agree to use an effective contraceptive method for the duration of the study\n\nExclusion Criteria:\n\n1. The subject has an underlying known disease surgical or medical condition, in the opinion of the investigator might interfere with interpretation of the study results or put the subject at risk (e.g., other dermatological diseases affecting the treatment area, such as a dermatitis, eczema, etc., or any uncontrolled chronic or serious diseases which would normally prevent participation in any clinical study, such as a cancer, leukemia or severe hepatic impairment), (Screening).\n2. The subject has acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.\n3. The subject has a known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator's Brochure/Product label).\n4. The subject is a male with beard or facial hair, which would interfere with clinical evaluation or clinical procedure (Screening and Baseline)."}, 'identificationModule': {'nctId': 'NCT03034460', 'briefTitle': 'Efficacy and Safety of CD5024 1% in Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'Efficacy and Safety of CD5024 1% in Acne Vulgaris', 'orgStudyIdInfo': {'id': 'RD.03.SPR.109807'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD5024 1% cream', 'description': 'Active drug;', 'interventionNames': ['Drug: CD5024 1% cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CD5024 cream placebo', 'description': 'Placebo of active drug;', 'interventionNames': ['Drug: CD5024 cream placebo']}, {'type': 'OTHER', 'label': 'CD0271/CD1579 gel', 'description': 'Positive control;', 'interventionNames': ['Drug: CD0271/CD1579 gel']}, {'type': 'OTHER', 'label': 'CD0271/CD1579 gel placebo', 'description': 'Placebo of positive control;', 'interventionNames': ['Drug: CD0271/CD1579 gel placebo']}], 'interventions': [{'name': 'CD5024 1% cream', 'type': 'DRUG', 'description': '500 µL on half-face, five days a week during 6 weeks', 'armGroupLabels': ['CD5024 1% cream']}, {'name': 'CD5024 cream placebo', 'type': 'DRUG', 'description': '500 µL on half-face, five days a week during 6 weeks', 'armGroupLabels': ['CD5024 cream placebo']}, {'name': 'CD0271/CD1579 gel', 'type': 'DRUG', 'description': '500 µL on half-face, five days a week during 6 weeks', 'armGroupLabels': ['CD0271/CD1579 gel']}, {'name': 'CD0271/CD1579 gel placebo', 'type': 'DRUG', 'description': '500 µL on half-face, five days a week during 6 weeks', 'armGroupLabels': ['CD0271/CD1579 gel placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N8W 5L7', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Galderma Investigational Site (# 8060)', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Galderma Investigational site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Galderma investigational site', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'country': 'France', 'facility': 'Galderma investigational site', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Galderma investigational site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Galderma investigational site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Galderma investigational site', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}