Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT01135069
Status:
COMPLETED
Last Update Posted:
2014-10-27
First Post:
2010-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% 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': 'spear@spearpharma.com', 'phone': '239-433-3442', 'title': 'K.L. Spear M.D.', 'organization': 'Spear Pharma'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'No unexpected problems.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Generic', 'description': 'Tretinoin Microsphere Gel 0.1%', 'otherNumAtRisk': 205, 'otherNumAffected': 26, 'seriousNumAtRisk': 205, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Brand', 'description': 'Retin-A Micro 0.1%', 'otherNumAtRisk': 209, 'otherNumAffected': 29, 'seriousNumAtRisk': 209, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Microsphere Gel no active', 'otherNumAtRisk': 66, 'otherNumAffected': 10, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Irritation', 'notes': 'Tretinoin produces irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Improvement in Acne', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Generic', 'description': 'treatment of acne for 12 weeks\n\nPercent change (reduction) in acne lesions was 74% reduction.'}, {'id': 'OG001', 'title': 'Brand', 'description': 'Treatment of acne for 12 weeks\n\nPercent change (reduction) in acne lesions was 76% reduction'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment of acne for 12 weeks\n\nPercent change (reduction) in acne lesions was 58% reduction'}], 'classes': [{'categories': [{'measurements': [{'value': '-74', 'spread': '.05', 'groupId': 'OG000'}, {'value': '-76', 'spread': '.04', 'groupId': 'OG001'}, {'value': '-58', 'spread': '.03', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Counting of acne lesions both inflammatory and non-inflammatory', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Generic', 'description': 'Tretinoin Microsphere Gel 0.1%'}, {'id': 'FG001', 'title': 'Brand', 'description': 'Retin-A Micro 0.1%'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Microsphere Gel no active'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}, {'groupId': 'FG001', 'numSubjects': '209'}, {'groupId': 'FG002', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}, {'groupId': 'FG001', 'numSubjects': '177'}, {'groupId': 'FG002', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '480', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Generic', 'description': 'Tretinoin Microsphere Gel 0.1%'}, {'id': 'BG001', 'title': 'Brand', 'description': 'Retin-A Micro 0.1%'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Microsphere Gel no active'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '233', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '247', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '21', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '19', 'spread': '6.7', 'groupId': 'BG002'}, {'value': '21', 'spread': '7.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '342', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '480', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 480}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-15', 'studyFirstSubmitDate': '2010-05-28', 'resultsFirstSubmitDate': '2013-05-28', 'studyFirstSubmitQcDate': '2010-06-01', 'lastUpdatePostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-09', 'studyFirstPostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Acne', 'timeFrame': '12 weeks', 'description': 'Counting of acne lesions both inflammatory and non-inflammatory'}]}, 'oversightModule': {'oversightHasDmc': False}, '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': 'Not required'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal, healthy male and female children and adult\n* Written and verbal informed consent must be obtained. Patients age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent.\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.\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\n* Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease.\n* Abnormal pre-existing skin condition which might affect the normal course of acne vulgaris (e.g., eczema, psoriasis, albinism, or chronic vesiculobullous disorders).\n* Use topical acne therapy during the two week period prior to study initiation.\n* Use of systemic retinoid treatment within six months prior to study initiation.\n* Pregnant or breast-feeding.\n* Serious psychological illness.\n* Participation in any clinical research study during the 30 day period preceding study initiation.'}, 'identificationModule': {'nctId': 'NCT01135069', 'briefTitle': 'Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spear Pharmaceuticals'}, 'officialTitle': 'Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo', 'orgStudyIdInfo': {'id': 'RAM-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Generic', 'description': 'treatment of acne for 12 weeks', 'interventionNames': ['Drug: Tretinoin microsphere 0.1%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brand', 'description': 'Treatment of acne for 12 weeks', 'interventionNames': ['Drug: Brand Retin-A Micro tretinoin microsphere gel 0.1%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Treatment if acne for 12 weeks as placebo', 'interventionNames': ['Drug: placebo microsphere gel']}], 'interventions': [{'name': 'Tretinoin microsphere 0.1%', 'type': 'DRUG', 'description': 'Treatment of acne vulgaris', 'armGroupLabels': ['Generic']}, {'name': 'Brand Retin-A Micro tretinoin microsphere gel 0.1%', 'type': 'DRUG', 'otherNames': ['Retin-A Micro'], 'description': 'Treatment of acne vulgaris', 'armGroupLabels': ['Brand']}, {'name': 'placebo microsphere gel', 'type': 'DRUG', 'description': 'treatment of acne vulgaris', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34628', 'city': "Land O' Lakes", 'state': 'Florida', 'country': 'United States', 'facility': 'Moore Clinical Research', 'geoPoint': {'lat': 28.2189, 'lon': -82.45759}}], 'overallOfficials': [{'name': 'Krunal Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moore Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spear Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}