Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT03393494
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2018-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}}}}, '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': 'D000068816', 'term': 'Adapalene'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jonathan.schwartz@perrigo.com', 'phone': '718-960-9900', 'title': 'Jonathan Schwartz', 'organization': 'Perrigo'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Perrigo Active', 'description': 'Test product\n\nAdapalene and Benzoyl Peroxide Topical Gel: Test product', 'otherNumAtRisk': 329, 'deathsNumAtRisk': 329, 'otherNumAffected': 0, 'seriousNumAtRisk': 329, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reference Active', 'description': 'RLD product\n\nEpiduo Topical Product: RLD product', 'otherNumAtRisk': 331, 'deathsNumAtRisk': 331, 'otherNumAffected': 0, 'seriousNumAtRisk': 331, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Perrigo Placebo', 'description': 'placebo product\n\nPlacebo: Placebo gel', 'otherNumAtRisk': 165, 'deathsNumAtRisk': 165, 'otherNumAffected': 0, 'seriousNumAtRisk': 165, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Cervical Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percent Change From Baseline in the Papules and Pustules Lesion Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Perrigo Active', 'description': 'Test product\n\nAdapalene and Benzoyl Peroxide Topical Gel: Test product'}, {'id': 'OG001', 'title': 'Reference Active', 'description': 'RLD product\n\nEpiduo Topical Product: RLD product'}, {'id': 'OG002', 'title': 'Perrigo Placebo', 'description': 'placebo product\n\nPlacebo: Placebo gel'}], 'classes': [{'categories': [{'measurements': [{'value': '68.18', 'spread': '28.96', 'groupId': 'OG000'}, {'value': '63.56', 'spread': '31.57', 'groupId': 'OG001'}, {'value': '50.72', 'spread': '35.12', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Equivalence ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '107', 'ciLowerLimit': '97.8', 'ciUpperLimit': '112.2', 'statisticalMethod': "Fieller's method", 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'provides 85% power of success'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to week 12', 'unitOfMeasure': 'percentage of lesion change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Perrigo Active', 'description': 'Test product\n\nAdapalene and Benzoyl Peroxide Topical Gel: Test product'}, {'id': 'OG001', 'title': 'Reference Active', 'description': 'RLD product\n\nEpiduo Topical Product: RLD product'}, {'id': 'OG002', 'title': 'Perrigo Placebo', 'description': 'placebo product\n\nPlacebo: Placebo gel'}], 'classes': [{'categories': [{'measurements': [{'value': '62.75', 'spread': '28.09', 'groupId': 'OG000'}, {'value': '60.78', 'spread': '33.73', 'groupId': 'OG001'}, {'value': '43.45', 'spread': '36.30', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Equivalence ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104', 'ciLowerLimit': '94.1', 'ciUpperLimit': '108.5', 'statisticalMethod': "Fieller's method", 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'provides 85% power of success'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to week 12', 'description': 'Per protocol population', 'unitOfMeasure': 'percentage of lesion change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test Product', 'description': 'Adapalene and Benzoyl Peroxide Topical Gel'}, {'id': 'FG001', 'title': 'Reference Product', 'description': 'Epiduo Topical Gel'}, {'id': 'FG002', 'title': 'Placebo Product', 'description': 'Placebo gel'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '329'}, {'groupId': 'FG001', 'numSubjects': '331'}, {'groupId': 'FG002', 'numSubjects': '165'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '261'}, {'groupId': 'FG001', 'numSubjects': '256'}, {'groupId': 'FG002', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '25'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'BG000'}, {'value': '331', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '825', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Perrigo Active', 'description': 'Test product\n\nAdapalene and Benzoyl Peroxide Topical Gel: Test product'}, {'id': 'BG001', 'title': 'Reference Active', 'description': 'RLD product\n\nEpiduo Topical Product: RLD product'}, {'id': 'BG002', 'title': 'Perrigo Placebo', 'description': 'placebo product\n\nPlacebo: Placebo gel'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '397', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '428', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '315', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '510', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '526', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '256', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '619', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-28', 'size': 1330139, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-10T16:56', 'hasProtocol': True}, {'date': '2017-09-28', 'size': 1273966, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-11-10T16:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 825}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'dispFirstSubmitDate': '2019-10-08', 'completionDateStruct': {'date': '2019-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2018-01-03', 'dispFirstSubmitQcDate': '2020-12-09', 'resultsFirstSubmitDate': '2020-11-13', 'studyFirstSubmitQcDate': '2018-01-03', 'dispFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-09', 'studyFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percent Change From Baseline in the Papules and Pustules Lesion Count', 'timeFrame': 'Day 1 to week 12'}, {'measure': 'Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count', 'timeFrame': 'Day 1 to week 12', 'description': 'Per protocol population'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': "To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of Acne Vulgaris"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed IRB approved written informed consent/assent\n2. 12 to 40 years of age, inclusive.\n3. Clinical diagnosis of facial acne vulgaris with an inflammatory lesion (papules and pustules) count of 20-50, inclusive and a non-inflammatory (open and closed comedones) lesion count of 25-100 inclusive and no more than 2 nodulocystic lesions (e.g., nodules and cysts) including those present on the nose.\n4. Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a severity scale of 0 to 4.\n5. Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.\n\nExclusion Criteria:\n\n1. Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.\n2. Presence of more than 2 facial Nodulocystic lesions.\n3. Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations\n4. Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments\n5. Excessive facial hair that would interfere with the diagnosis or assessment of acne vulgaris.\n6. History of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy.\n7. Currently using any product containing adapalene and/or benzoyl peroxide and/or belonging to the same family.\n8. History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any ingredient in the study medication.\n9. Use of medications known to exacerbate acne\n10. Start or change within 3 months (90 days) of Visit 1 and throughout the study\n11. Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study\n12. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.\n13. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study."}, 'identificationModule': {'nctId': 'NCT03393494', 'briefTitle': 'Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face', 'organization': {'class': 'INDUSTRY', 'fullName': 'Padagis LLC'}, 'officialTitle': "Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo's Adapalene/BP Gel to Galderma's Epiduo (Adapalene/BP) Gel, and Both Treatments to a Vehicle Control in the Treatment of Acne Vulgaris", 'orgStudyIdInfo': {'id': 'PRG-NY-17-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Perrigo active', 'description': 'Test product', 'interventionNames': ['Drug: Adapalene and Benzoyl Peroxide Topical Gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference active', 'description': 'RLD product', 'interventionNames': ['Drug: Epiduo Topical Product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Perrigo placebo', 'description': 'placebo product', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Adapalene and Benzoyl Peroxide Topical Gel', 'type': 'DRUG', 'description': 'Test product', 'armGroupLabels': ['Perrigo active']}, {'name': 'Epiduo Topical Product', 'type': 'DRUG', 'description': 'RLD product', 'armGroupLabels': ['Reference active']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo gel', 'armGroupLabels': ['Perrigo placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermatology Consultants', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Padagis LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}