Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-25 @ 7:52 PM
Study NCT ID:
NCT01138735
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2010-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Epiduo Pediatric Acne Study
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': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'LOCF data were used for primary efficacy and secondary efficacy data.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Adapalene/Benzoyl Peroxide', 'description': 'Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks', 'otherNumAtRisk': 142, 'otherNumAffected': 37, 'seriousNumAtRisk': 142, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Topical Gel Vehicle', 'description': 'Topical Gel Vehicle applied topically once daily for 12 weeks', 'otherNumAtRisk': 143, 'otherNumAffected': 18, 'seriousNumAtRisk': 143, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Skin burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'RIGHT FRONTAL ARTERIOVENOUS MALFORMATION', 'notes': 'occurred on Day 2, resolved on Day 29 and the subject completed the study as planned.Severe, nonrelated Adverse Events (AE), Inpatient hospitalization.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapalene/Benzoyl Peroxide', 'description': 'Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Topical Gel Vehicle', 'description': 'Topical Gel Vehicle applied topically once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed 'positive' if all primary analyses are shown statistically significant at the 0.05 level.", 'groupDescription': 'null hypothesis: no difference in Success rate in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle).\n\npower calculation: 90%', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Cochran-Mantel-Haenszel(CMH) test stratified by analysis center, using general association statistics'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12 (Last Observation Carried Forward [LOCF])', 'description': "Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)", 'unitOfMeasure': 'percentage of participant', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population, LOCF'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Total Lesion Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapalene/Benzoyl Peroxide', 'description': 'Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Topical Gel Vehicle', 'description': 'Topical Gel Vehicle applied topically once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.6', 'spread': '22.43', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '24.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed 'positive' if all primary analyses are shown statistically significant at the 0.05 level.", 'groupDescription': 'null hypothesis: no difference in change from baseline in total lesion count in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'normality assumption is not met. ANCOVA Model: Ranked Change in Total Lesion Counts = Ranked Baseline Lesion Counts, Analysis Center, Treatment.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12 (LOCF)', 'unitOfMeasure': 'lesion count change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, LOCF'}, {'type': 'SECONDARY', 'title': 'Percent Change in Total Lesion Counts From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapalene/Benzoyl Peroxide', 'description': 'Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Topical Gel Vehicle', 'description': 'Topical Gel Vehicle applied topically once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.5', 'spread': '38.99', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '48.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'CMH test with row mean difference statistic using relative to an identified distribution(RIDIT) score, controlling for analysis center'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12 (LOCF)', 'unitOfMeasure': 'percentage of change in lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population, LOCF'}, {'type': 'SECONDARY', 'title': 'Change in Inflammatory Lesion Counts From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapalene/Benzoyl Peroxide', 'description': 'Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Topical Gel Vehicle', 'description': 'Topical Gel Vehicle applied topically once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.4', 'spread': '12.46', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '12.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Ranked Change in Inflammatory Lesion Counts = Ranked Baseline Inflammatory Lesion Counts, Analysis Center, Treatment'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12 (LOCF)', 'unitOfMeasure': 'lesion count change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population, LOCF'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adapalene/Benzoyl Peroxide', 'description': 'Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks'}, {'id': 'FG001', 'title': 'Topical Gel Vehicle', 'description': 'Topical Gel Vehicle applied topically once daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Adapalene/Benzoyl Peroxide', 'description': 'Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks'}, {'id': 'BG001', 'title': 'Topical Gel Vehicle', 'description': 'Topical Gel Vehicle applied topically once daily for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '0.76', 'groupId': 'BG000'}, {'value': '10.4', 'spread': '0.68', 'groupId': 'BG001'}, {'value': '10.4', 'spread': '0.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 285}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'dispFirstSubmitDate': '2012-05-07', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2010-06-04', 'dispFirstSubmitQcDate': '2012-05-07', 'resultsFirstSubmitDate': '2013-02-19', 'studyFirstSubmitQcDate': '2010-06-04', 'dispFirstPostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-02-19', 'studyFirstPostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success Rate', 'timeFrame': 'Baseline to Week 12 (Last Observation Carried Forward [LOCF])', 'description': "Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)"}, {'measure': 'Change From Baseline in Total Lesion Counts', 'timeFrame': 'Baseline to Week 12 (LOCF)'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Total Lesion Counts From Baseline', 'timeFrame': 'Baseline to Week 12 (LOCF)'}, {'measure': 'Change in Inflammatory Lesion Counts From Baseline', 'timeFrame': 'Baseline to Week 12 (LOCF)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of acne vulgaris with facial involvement\n* Score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale\n* A minimum of 20 but not more than 100 total lesions (Noninflammatory and/or Inflammatory) on the face (including the nose) at Baseline\n\nExclusion Criteria:\n\n* Acne nodule or acne cyst\n* Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment\n* Underlying diseases and/or dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments\n* Use of prohibited medications prior to the study and/or are unwilling to refrain from such use during the study"}, 'identificationModule': {'nctId': 'NCT01138735', 'briefTitle': 'Epiduo Pediatric Acne Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Multi-center, Randomized, Vehicle-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Administered Once Daily for the Treatment of Subjects 9 to 11 Years of Age With Acne Vulgaris', 'orgStudyIdInfo': {'id': 'RD.06.SPR.18155'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'adapalene/benzoyl peroxide', 'description': 'Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks', 'interventionNames': ['Drug: adapalene/benzoyl peroxide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Topical Gel Vehicle', 'description': 'Topical Gel Vehicle applied topically once daily for 12 weeks', 'interventionNames': ['Drug: Topical Gel Vehicle']}], 'interventions': [{'name': 'adapalene/benzoyl peroxide', 'type': 'DRUG', 'otherNames': ['Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%'], 'description': 'daily topical application for 12 weeks', 'armGroupLabels': ['adapalene/benzoyl peroxide']}, {'name': 'Topical Gel Vehicle', 'type': 'DRUG', 'description': 'daily topical application for 12 weeks', 'armGroupLabels': ['Topical Gel Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Dermatology Clinical Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital and Health Center Division of Pediatric and Adolescent Dermatology", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Redwood Family Dermatology', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '33027', 'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'FXM Research Miramar', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Adult & Pediatric Dermatology', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Dermatology Specialists Research', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health Systems Department 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