Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-06 @ 2:43 PM
Study NCT ID:
NCT02938494
Status:
COMPLETED
Last Update Posted:
2020-09-23
First Post:
2016-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of IDP-123 Lotion to Tazorac® Cream, 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': 'C086827', 'term': 'tazarotene'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anya.loncaric@bauschhealth.com', 'title': 'Study Director', 'organization': 'Bausch Health'}, 'certainAgreement': {'otherDetails': 'Contact sponsor directly for details.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Randomized participants who used study drug at least once and provided ≥1 post-Baseline evaluation (Safety Population).', 'eventGroups': [{'id': 'EG000', 'title': 'IDP-123 Lotion', 'description': 'Lotion\n\nIDP-123 Lotion: Lotion', 'otherNumAtRisk': 68, 'otherNumAffected': 2, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tazorac Cream', 'description': 'Cream\n\nTazorac Cream: Cream', 'otherNumAtRisk': 71, 'otherNumAffected': 4, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Vehicle Lotion', 'description': 'Lotion\n\nVehicle Lotion: Lotion', 'otherNumAtRisk': 34, 'otherNumAffected': 1, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Vehicle Cream', 'description': 'Cream\n\nVehicle Cream: Cream', 'otherNumAtRisk': 33, 'otherNumAffected': 2, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IDP-123 Lotion', 'description': '0.045% tazarotene'}, {'id': 'OG001', 'title': 'Tazorac Cream', 'description': 'Tazorac Cream 0.1%'}, {'id': 'OG002', 'title': 'Vehicle Lotion and Vehicle Cream Combined', 'description': 'Vehicle Lotion and Vehicle Cream Combined'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.6', 'spread': '13.98', 'groupId': 'OG000'}, {'value': '-20.3', 'spread': '13.67', 'groupId': 'OG001'}, {'value': '-13.1', 'spread': '13.62', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Week 12', 'description': 'Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses compared IDP-123 Lotion and the combined Vehicle Lotion and Vehicle Cream groups, as pre-specified in the statistical analysis plan. There is no information for separate Vehicle Lotion and Vehicle Cream groups, since the comparator group was pre-specified to be combined Vehicle Lotion and Vehicle Cream.'}, {'type': 'PRIMARY', 'title': 'Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IDP-123 Lotion', 'description': '0.045% tazarotene'}, {'id': 'OG001', 'title': 'Tazorac Cream', 'description': 'Tazorac Cream 0.1%'}, {'id': 'OG002', 'title': 'Vehicle Lotion and Vehicle Cream Combined', 'description': 'Vehicle Lotion and Vehicle Cream Combined'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.1', 'spread': '8.99', 'groupId': 'OG000'}, {'value': '-16.8', 'spread': '10.96', 'groupId': 'OG001'}, {'value': '-14.0', 'spread': '8.64', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses compared IDP-123 Lotion and the combined Vehicle Lotion and Vehicle Cream groups, as pre-specified in the statistical analysis plan. There is no information for separate Vehicle Lotion and Vehicle Cream groups, since the comparator group was pre-specified to be combined Vehicle Lotion and Vehicle Cream.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment Success at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IDP-123 Lotion', 'description': '0.045% tazarotene'}, {'id': 'OG001', 'title': 'Tazorac Cream', 'description': 'Tazorac Cream 0.1%'}, {'id': 'OG002', 'title': 'Vehicle Lotion and Vehicle Cream Combined', 'description': 'Vehicle Lotion and Vehicle Cream Combined'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 12', 'description': 'Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses compared IDP-123 Lotion and the combined Vehicle Lotion and Vehicle Cream groups, as pre-specified in the statistical analysis plan. There is no information for separate Vehicle Lotion and Vehicle Cream groups, since the comparator group was pre-specified to be combined Vehicle Lotion and Vehicle Cream.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IDP-123 Lotion', 'description': 'Lotion\n\nIDP-123 Lotion: Lotion'}, {'id': 'FG001', 'title': 'Tazorac Cream', 'description': 'Cream\n\nTazorac Cream: Cream'}, {'id': 'FG002', 'title': 'Vehicle Lotion', 'description': 'Lotion\n\nVehicle Lotion: Lotion'}, {'id': 'FG003', 'title': 'Vehicle Cream', 'description': 'Cream\n\nVehicle Cream: Cream'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '210', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'IDP-123 Lotion', 'description': 'Lotion\n\nIDP-123 Lotion: Lotion'}, {'id': 'BG001', 'title': 'Tazorac Cream', 'description': 'Cream\n\nTazorac Cream: Cream'}, {'id': 'BG002', 'title': 'Vehicle Lotion', 'description': 'Lotion\n\nVehicle Lotion: Lotion'}, {'id': 'BG003', 'title': 'Vehicle Cream', 'description': 'Cream\n\nVehicle Cream: Cream'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '22.0', 'spread': '8.96', 'groupId': 'BG001'}, {'value': '21.2', 'spread': '9.27', 'groupId': 'BG002'}, {'value': '21.2', 'spread': '7.96', 'groupId': 'BG003'}, {'value': '22.2', 'spread': '9.23', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'dispFirstSubmitDate': '2018-01-16', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-03', 'studyFirstSubmitDate': '2016-10-11', 'dispFirstSubmitQcDate': '2018-01-16', 'resultsFirstSubmitDate': '2020-08-08', 'studyFirstSubmitQcDate': '2016-10-17', 'dispFirstPostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-03', 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12', 'timeFrame': 'Baseline (Day 0), Week 12', 'description': 'Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.'}, {'measure': 'Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.'}, {'measure': 'Percentage of Participants With Treatment Success at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris', 'detailedDescription': 'A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Study to Compare the Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Male or female at least 12 years of age and older.\n* Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit).\n* Women of childbearing potential and females that are pre-menses must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, IUD, condom with spermicidal, diaphragm with spermicidal, implant, Nuvaring, injection, transdermal patch or abstinence.) Females on birth control pills must have taken the same type pill for at least three months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least three months prior to the start of the study. Women who use birth control for acne control only should be excluded.\n* Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits.\n\nKey Exclusion Criteria:\n\n* Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;\n* Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis, dermatitis, eczema.\n* Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.\n* Subjects with a facial beard or mustache that could interfere with the study assessments.\n* Evidence or history of cosmetic-related acne.\n* Subject has a history of experiencing significant burning or stinging when applying any facial treatment (eg, make-up, soap, masks, washes, sunscreens, etc) to their face.'}, 'identificationModule': {'nctId': 'NCT02938494', 'briefTitle': 'Safety and Efficacy of IDP-123 Lotion to Tazorac® Cream, in the Treatment of Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac® (Tazarotene) Cream, in the Treatment of Acne Vulgaris', 'orgStudyIdInfo': {'id': 'V01-123A-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDP-123 Lotion', 'description': 'Lotion', 'interventionNames': ['Drug: IDP-123 Lotion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tazorac Cream', 'description': 'Cream', 'interventionNames': ['Drug: Tazorac Cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vehicle Lotion', 'description': 'Lotion', 'interventionNames': ['Drug: Vehicle Lotion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vehicle Cream', 'description': 'Cream', 'interventionNames': ['Drug: Vehicle Cream']}], 'interventions': [{'name': 'IDP-123 Lotion', 'type': 'DRUG', 'otherNames': ['Lotion'], 'description': 'Lotion', 'armGroupLabels': ['IDP-123 Lotion']}, {'name': 'Tazorac Cream', 'type': 'DRUG', 'otherNames': ['Tazorac'], 'description': 'Cream', 'armGroupLabels': ['Tazorac Cream']}, {'name': 'Vehicle Lotion', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'Lotion', 'armGroupLabels': ['Vehicle Lotion']}, {'name': 'Vehicle Cream', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'Cream', 'armGroupLabels': ['Vehicle Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 03', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 04', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 06', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 14', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 01', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80915', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Valeant Site 05', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Valeant Site 08', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Valeant Site 10', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33027', 'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'Valeant Site 09', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Valeant Site 12', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Valeant Site 13', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Valeant Site 02', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Valeant Site 07', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '27517', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Valeant Site 16', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Valeant Site 15', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Valeant Site 11', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Anya Loncaric', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Valeant Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}