Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT01243450
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2010-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo
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': 'D014212', 'term': 'Tretinoin'}], 'ancestors': [{'id': 'D014801', 'term': 'Vitamin A'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wcunningham@cu-tech.com', 'phone': '(973) 331-1620', 'title': 'William J. Cunningham, MD', 'organization': 'Cu-Tech, LLC'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Active Generic', 'description': 'active cream\n\nTretinoin: Topical skin', 'otherNumAtRisk': 401, 'otherNumAffected': 0, 'seriousNumAtRisk': 401, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo cream\n\nTretinoin: Topical skin\n\nplacebo', 'otherNumAtRisk': 135, 'otherNumAffected': 0, 'seriousNumAtRisk': 135, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Brand', 'description': 'Tretinoin: Topical skin', 'otherNumAtRisk': 404, 'otherNumAffected': 0, 'seriousNumAtRisk': 404, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Appendicitis', 'notes': 'appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 404, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acne Lesion Percent Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '337', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Generic', 'description': 'active cream\n\nTretinoin: Topical skin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo cream\n\nTretinoin: Topical skin\n\nplacebo'}, {'id': 'OG002', 'title': 'Brand', 'description': 'Tretinoin: Topical skin'}], 'classes': [{'categories': [{'measurements': [{'value': '-54.3', 'spread': '10', 'groupId': 'OG000'}, {'value': '-35', 'spread': '8', 'groupId': 'OG001'}, {'value': '-53.5', 'spread': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 week', 'description': 'Reduction in number of Acne lesions by counting over 12 weeks', 'unitOfMeasure': 'percent reduction of number of lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Generic', 'description': 'active cream\n\nTretinoin: Topical skin'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'placebo cream\n\nTretinoin: Topical skin\n\nplacebo'}, {'id': 'FG002', 'title': 'Brand', 'description': 'Tretinoin: Topical skin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '401'}, {'groupId': 'FG001', 'numSubjects': '135'}, {'groupId': 'FG002', 'numSubjects': '404'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '318'}, {'groupId': 'FG001', 'numSubjects': '110'}, {'groupId': 'FG002', 'numSubjects': '337'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '67'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'BG000'}, {'value': '404', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '940', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Generic', 'description': 'Active generic group'}, {'id': 'BG001', 'title': 'Brand', 'description': 'Brand group'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo group'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.2', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '17.1', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '17.6', 'spread': '6.3', 'groupId': 'BG002'}, {'value': '17.2', 'spread': '6.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '484', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '208', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '456', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '401', 'groupId': 'BG000'}, {'value': '404', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '940', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 958}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-28', 'studyFirstSubmitDate': '2010-11-16', 'resultsFirstSubmitDate': '2014-09-07', 'studyFirstSubmitQcDate': '2010-11-17', 'lastUpdatePostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-11-17', 'studyFirstPostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acne Lesion Percent Reduction', 'timeFrame': '12 week', 'description': 'Reduction in number of Acne lesions by counting over 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acne']}, 'descriptionModule': {'briefSummary': "The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.", 'detailedDescription': 'Acne study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'A subject will be eligible to participate if they meet all of the following inclusion criteria:\n\n* Normal, healthy male and female children and adults.\n* Age 12 to 40 years.\n* Written and verbal informed consent must be obtained. Subjects age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent (per FDA letter 8.21.07).\n* Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study, adequate contraception is defined as regular use of any two of the following: oral, injectable contraceptives, condoms, spermicides, diaphragm, IUD, implantable and contraceptive patches. (oral contraceptives if used for at least three months and injectable contraceptives if used for at least 6 months)- prior to enrollment in the study, or abstinence.\n* Have at least 20 inflammatory (papules and pustules) and 25 non-inflammatory (open and closed comedones) lesions with a maximum of 2 nodulocystic lesions on the face (per FDA letter 8.21.07).\n* Global severity score from 2-4\n* Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period.\n* Considered reliable and capable of understanding their responsibility and role in the study.\n\nExclusion Criteria\n\nA subject will be eligible to participate if they meet none of the following exclusion criteria:\n\n* Subjects with active cystic acne as evidenced by more than 2 facial nodules.\n* More than 40 papules and/or pustules (inflammatory lesions)\n* More than 60 open and or closed comedones/milia (non-inflammatory lesions)\n* Overall severity grade of less than 2 or greater than 4,\n* History of allergy or hypersensitivity to tretinoin.\n* Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease\n* Use of systemic retinoid treatment within six months prior to study initiation.\n* Oral contraceptives should not be started or changed within 3 months prior to study initiation or planned to change during the study.\n* Pregnant or breast-feeding.\n* Participation in a clinical study for acne within 4 months preceding study initiation.'}, 'identificationModule': {'nctId': 'NCT01243450', 'briefTitle': 'Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spear Pharmaceuticals'}, 'officialTitle': 'Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo', 'orgStudyIdInfo': {'id': 'RAM-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active generic', 'description': 'Treatment of acne for 12 weeks with generic tretinoin', 'interventionNames': ['Drug: Tretinoin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Treatment of acne for 12 weeks with Placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brand', 'description': 'Treatment of acne over 12 weeks with tretinoin Brand', 'interventionNames': ['Drug: Tretinoin']}], 'interventions': [{'name': 'Tretinoin', 'type': 'DRUG', 'otherNames': ['active medication'], 'description': 'Treatment of acne', 'armGroupLabels': ['Active generic', 'Brand']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['inactive medication'], 'description': 'treatment of acne', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07046', 'city': 'Mountain Lakes', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cu-Tech, LLC', 'geoPoint': {'lat': 40.89482, 'lon': -74.43293}}], 'overallOfficials': [{'name': 'William Cunningham, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cu-Tech'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spear Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}