Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-04 @ 8:42 AM
Study NCT ID:
NCT02465632
Status:
COMPLETED
Last Update Posted:
2017-06-28
First Post:
2015-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002981', 'term': 'Clindamycin'}, {'id': 'D001585', 'term': 'Benzoyl Peroxide'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialsdisclosuredesk@glenmarkpharma.com', 'phone': '91 2267720000', 'title': 'Cathy Tyrrell', 'organization': 'Glenmark Pharmaceuticals Ltd'}, 'certainAgreement': {'otherDetails': 'Per the agreement, Sponsor reserves the right for publishing trial results and the Investigator cannot publish without written consent from the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'A total of 1100 subjects were randomized in the study; of these 27 subjects did not received the dose (Test=8, Reference=10, Placebo=9) and were excluded from the safety population randomized. Therefore the total number of Participants at risk is not consistent with any of the rows of the Participant Flow module.', 'eventGroups': [{'id': 'EG000', 'title': 'Test', 'description': 'Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel', 'otherNumAtRisk': 432, 'otherNumAffected': 0, 'seriousNumAtRisk': 432, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reference', 'description': 'BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%', 'otherNumAtRisk': 430, 'otherNumAffected': 0, 'seriousNumAtRisk': 430, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo topical gel', 'otherNumAtRisk': 211, 'otherNumAffected': 0, 'seriousNumAtRisk': 211, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Clindamycin and Benzoyl Peroxide Gel, 1%/5%'}, {'id': 'OG001', 'title': 'Reference', 'description': 'BenzaClin® Topical Gel: Clindamycin and Benzoyl Peroxide Gel, 1%/5%'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: Placebo topical gel'}], 'classes': [{'categories': [{'measurements': [{'value': '72.3', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '71.1', 'spread': '26.7', 'groupId': 'OG001'}, {'value': '39.1', 'spread': '31.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 10 Weeks', 'description': 'The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Clindamycin and Benzoyl Peroxide Gel, 1%/5%'}, {'id': 'OG001', 'title': 'Reference', 'description': 'BenzaClin® Topical Gel: Clindamycin and Benzoyl Peroxide Gel, 1%/5%'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: Placebo Topical Gel'}], 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '63.3', 'spread': '26.2', 'groupId': 'OG001'}, {'value': '30.9', 'spread': '28.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 10 Weeks', 'description': 'The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.', 'unitOfMeasure': 'Percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel', 'description': 'Test: A thin layer of gel was applied to the entire affected areas on the face twice a day.'}, {'id': 'FG001', 'title': 'BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%', 'description': 'Reference: A thin layer of gel was applied to the entire affected areas on the face twice a day.'}, {'id': 'FG002', 'title': 'Placebo Topical Gel', 'description': 'Placebo: A thin layer of gel was applied to the entire affected areas on the face twice a day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '440'}, {'groupId': 'FG001', 'numSubjects': '440'}, {'groupId': 'FG002', 'numSubjects': '220'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '409'}, {'groupId': 'FG001', 'numSubjects': '417'}, {'groupId': 'FG002', 'numSubjects': '203'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'BG000'}, {'value': '430', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}, {'value': '1073', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Test', 'description': 'Test: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel'}, {'id': 'BG001', 'title': 'Reference', 'description': 'Reference: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo: Placebo topical gel'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.8', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '22.3', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '22.6', 'spread': '7.5', 'groupId': 'BG002'}, {'value': '22.6', 'spread': '7.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '274', 'groupId': 'BG000'}, {'value': '259', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}, {'value': '660', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '413', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of 1100 subjects were randomized in the study; of these 27 subjects did not received the dose (Test=8, Reference=10, Placebo=9) and were excluded from the safety population randomized. Therefore the overall number of subjects in the Baseline Participants module is not consistent with any of the rows of the Participant Flow module.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-26', 'studyFirstSubmitDate': '2015-06-04', 'resultsFirstSubmitDate': '2017-04-18', 'studyFirstSubmitQcDate': '2015-06-04', 'lastUpdatePostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-26', 'studyFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)', 'timeFrame': 'Baseline and 10 Weeks', 'description': 'The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.'}, {'measure': 'Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)', 'timeFrame': 'Baseline and 10 Weeks', 'description': 'The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5% topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel, Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.\n2. Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.\n\nExclusion Criteria:\n\n1. Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.\n2. Subject has active cystic acne.\n3. Subject has acne conglobata.\n4. Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.'}, 'identificationModule': {'nctId': 'NCT02465632', 'briefTitle': 'To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glenmark Pharmaceuticals Ltd. India'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) to the Marketed Product BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% (Valeant Pharmaceuticals, US) in the Treatment of Acne Vulgaris.', 'orgStudyIdInfo': {'id': 'GLK-1403'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel', 'description': 'apply a thin layer of gel to the face', 'interventionNames': ['Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%', 'description': 'apply a thin layer of the gel to the face', 'interventionNames': ['Drug: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo topical gel', 'description': 'apply a thin layer of the gel to the face', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel', 'type': 'DRUG', 'armGroupLabels': ['Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel']}, {'name': 'BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%', 'type': 'DRUG', 'armGroupLabels': ['BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo topical gel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 13', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 6', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 15', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'West Covina', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site12', 'geoPoint': {'lat': 34.06862, 'lon': -117.93895}}, {'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 4', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 1', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 8', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 9', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 2', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Glenmark Investigational Site 5', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Upper Saint Clair', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Glenmark Investigational Site7', 'geoPoint': {'lat': 40.3359, 'lon': -80.08339}}, {'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Glenmark Investigational Site 14', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Glenmark Investigational Site 3', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Belize City', 'country': 'Belize', 'facility': 'Glenmark Investigational Site 10', 'geoPoint': {'lat': 17.49952, 'lon': -88.19756}}, {'city': 'Belize City', 'country': 'Belize', 'facility': 'Glenmark Investigational Site 11', 'geoPoint': {'lat': 17.49952, 'lon': -88.19756}}], 'overallOfficials': [{'name': 'Mahesh V Deshpande', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glenmark Pharmaceuticals Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glenmark Pharmaceuticals Ltd. India', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}