Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-01-01 @ 9:43 PM
Study NCT ID:
NCT02785159
Status:
COMPLETED
Last Update Posted:
2020-08-20
First Post:
2016-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue 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': 'Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).', 'eventGroups': [{'id': 'EG000', 'title': 'IDP-118 Lotion', 'description': 'Lotion\n\nIDP-118 Lotion: Lotion', 'otherNumAtRisk': 60, 'otherNumAffected': 10, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Tazorac Cream', 'description': 'Cream\n\nTazorac Cream: Cream', 'otherNumAtRisk': 57, 'otherNumAffected': 8, 'seriousNumAtRisk': 57, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'IDP 118 Vehicle Lotion', 'description': 'Lotion\n\nIDP-118 Vehicle Lotion: Lotion', 'otherNumAtRisk': 15, 'otherNumAffected': 4, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'IDP-118 Vehicle Cream', 'description': 'Cream\n\nIDP-118 Vehicle Cream: Cream', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Application site pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Subjects With Treatment Success, Defined by at Least a 2 Grade Improvement From Baseline in the Investigator Global Assessment (IGA) Score Equating to Clear or Almost Clear.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IDP-118 Lotion', 'description': 'Lotion\n\nIDP-118 Lotion: Lotion'}, {'id': 'OG001', 'title': 'Tazorac Cream', 'description': 'Cream\n\nTazorac Cream: Cream'}, {'id': 'OG002', 'title': 'IDP 118 Vehicle Lotion', 'description': 'Lotion\n\nIDP-118 Vehicle Lotion: Lotion'}, {'id': 'OG003', 'title': 'IDP-118 Vehicle Cream', 'description': 'Cream\n\nIDP-118 Vehicle Cream: Cream'}], 'classes': [{'categories': [{'measurements': [{'value': '31.66', 'groupId': 'OG000'}, {'value': '13.77', 'groupId': 'OG001'}, {'value': '15.90', 'groupId': 'OG002'}, {'value': '7.96', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Weeks', 'description': 'Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator\'s Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear". The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IDP-118 Lotion', 'description': 'Lotion\n\nIDP-118 Lotion: Lotion'}, {'id': 'FG001', 'title': 'Tazorac Cream', 'description': 'Cream\n\nTazorac Cream: Cream'}, {'id': 'FG002', 'title': 'IDP 118 Vehicle Lotion', 'description': 'Lotion\n\nIDP-118 Vehicle Lotion: Lotion'}, {'id': 'FG003', 'title': 'IDP-118 Vehicle Cream', 'description': 'Cream\n\nIDP-118 Vehicle Cream: Cream'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '152', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'IDP-118 Lotion', 'description': 'Lotion\n\nIDP-118 Lotion: Lotion'}, {'id': 'BG001', 'title': 'Tazorac Cream', 'description': 'Cream\n\nTazorac Cream: Cream'}, {'id': 'BG002', 'title': 'IDP 118 Vehicle Lotion', 'description': 'Lotion\n\nIDP-118 Vehicle Lotion: Lotion'}, {'id': 'BG003', 'title': 'IDP-118 Vehicle Cream', 'description': 'Cream\n\nIDP-118 Vehicle Cream: Cream'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.4', 'spread': '14.58', 'groupId': 'BG000'}, {'value': '48.4', 'spread': '12.37', 'groupId': 'BG001'}, {'value': '48.9', 'spread': '14.78', 'groupId': 'BG002'}, {'value': '56.8', 'spread': '11.92', 'groupId': 'BG003'}, {'value': '49.81', 'spread': '13.61', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '96', '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': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'dispFirstSubmitDate': '2017-12-13', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-08', 'studyFirstSubmitDate': '2016-04-26', 'dispFirstSubmitQcDate': '2017-12-13', 'resultsFirstSubmitDate': '2020-08-08', 'studyFirstSubmitQcDate': '2016-05-24', 'dispFirstPostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-08', 'studyFirstPostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Subjects With Treatment Success, Defined by at Least a 2 Grade Improvement From Baseline in the Investigator Global Assessment (IGA) Score Equating to Clear or Almost Clear.', 'timeFrame': '12 Weeks', 'description': 'Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator\'s Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear". The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis', 'detailedDescription': 'A Phase 2, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion with Tazorac (tazarotene) Cream, 0.05% in the Treatment of Plaque Psoriasis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Male or female, of any race, at least 18 years of age (inclusive).\n* Freely provides both verbal and written informed consent.\n* Has an area of plaque psoriasis appropriate for topical treatment that covers a Body Surface Area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation.\n* Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.\n* Has a clinical diagnosis of psoriasis at the Baseline visit with an (IGA) Investigator Global Assessment score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment, if psoriasis is present.)\n\nKey Exclusion Criteria:\n\n* Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.\n* Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.\n* Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.\n* Is pregnant, nursing an infant, or planning a pregnancy during the study period.\n* Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.'}, 'identificationModule': {'nctId': 'NCT02785159', 'briefTitle': 'Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Phase 2, Multicenter, Double Blinded, Randomized, Vehicle Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion With Tazorac (Tazarotene) Cream, 0.05% in the Treatment of Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'V01-118A-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDP-118 Lotion', 'description': 'Lotion', 'interventionNames': ['Drug: IDP-118 Lotion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tazorac Cream', 'description': 'Cream', 'interventionNames': ['Drug: Tazorac Cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IDP 118 Vehicle Lotion', 'description': 'Lotion', 'interventionNames': ['Drug: IDP-118 Vehicle Lotion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IDP-118 Vehicle Cream', 'description': 'Cream', 'interventionNames': ['Drug: IDP-118 Vehicle Cream']}], 'interventions': [{'name': 'IDP-118 Lotion', 'type': 'DRUG', 'otherNames': ['Lotion'], 'description': 'Lotion', 'armGroupLabels': ['IDP-118 Lotion']}, {'name': 'Tazorac Cream', 'type': 'DRUG', 'otherNames': ['Tazorac'], 'description': 'Cream', 'armGroupLabels': ['Tazorac Cream']}, {'name': 'IDP-118 Vehicle Lotion', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'Lotion', 'armGroupLabels': ['IDP 118 Vehicle Lotion']}, {'name': 'IDP-118 Vehicle Cream', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'Cream', 'armGroupLabels': ['IDP-118 Vehicle Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91316', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 12', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '32065', 'city': 'Orange Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Valeant Site 13', 'geoPoint': {'lat': 30.16607, 'lon': -81.70648}}, {'zip': '33780', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Valeant Site 11', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '33601', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Valeant Site 01', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33601', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Valeant Site 04', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46168', 'city': 'Plainfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'Valeant Site 05', 'geoPoint': {'lat': 39.70421, 'lon': -86.39944}}, {'zip': '48346', 'city': 'Clarkston', 'state': 'Michigan', 'country': 'United States', 'facility': 'Valeant Site 09', 'geoPoint': {'lat': 42.73586, 'lon': -83.41883}}, {'zip': '55421', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Valeant Site 07', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '64501', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'Valeant Site 14', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '29601', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Valeant Site 10', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37129', 'city': 'Murfreesboro', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Valeant Site 03', 'geoPoint': {'lat': 35.84562, 'lon': -86.39027}}, {'zip': '77840', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'Valeant Site 06', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Valeant Site 08', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '22901', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Valeant Site 02', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Binu J Alexander, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Valeant Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}