Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-02-11 @ 12:39 AM
Study NCT ID:
NCT02616250
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2015-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068438', 'term': 'Brimonidine Tartrate'}, {'id': 'D005782', 'term': 'Gels'}, {'id': 'D007559', 'term': 'Ivermectin'}, {'id': 'D000069416', 'term': 'Intravital Microscopy'}], 'ancestors': [{'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008853', 'term': 'Microscopy'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fabien.audibert@galderma.com', 'phone': '+33 (0) 4 9238 3034', 'title': 'Fabien AUDIBERT, Sr CPM', 'organization': 'GALDERMA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "All AEs occurring after subject's consent and during the study were recorded; 3 months for a given subject 10 months for the study; ie: from first subject enrolled until last visit of last subject enrolled", 'eventGroups': [{'id': 'EG000', 'title': 'Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream', 'description': 'Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.\n\nHalf group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.\n\nBrimonidine 0.33% gel (Br)\n\nCD07805/47 (Br) placebo gel\n\nIvermectin 1% cream (IVM)', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 8, 'seriousNumAtRisk': 95, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream', 'description': 'Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.\n\nCD07805/47 (Br) placebo gel\n\nCD5024 (IVM) placebo cream', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 13, 'seriousNumAtRisk': 95, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Biliary cirrhosis primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):", 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream', 'description': 'Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.\n\nHalf group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.\n\nBrimonidine 0.33% gel (Br)\n\nCD07805/47 (Br) placebo gel\n\nIvermectin 1% cream (IVM)'}, {'id': 'OG001', 'title': 'CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream', 'description': 'Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.\n\nCD07805/47 (Br) placebo gel\n\nCD5024 (IVM) placebo cream'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 12/Hour 3', 'description': 'Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent To Treat (ITT) Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream', 'description': 'Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.\n\nHalf group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.\n\nBrimonidine 0.33% gel (Br)\n\nCD07805/47 (Br) placebo gel\n\nIvermectin 1% cream (IVM)'}, {'id': 'FG001', 'title': 'CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream', 'description': 'Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.\n\nCD07805/47 (Br) placebo gel\n\nCD5024 (IVM) placebo cream'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream', 'description': 'Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.\n\nHalf group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.\n\nBrimonidine 0.33% gel (Br)\n\nCD07805/47 (Br) placebo gel\n\nIvermectin 1% cream (IVM)'}, {'id': 'BG001', 'title': 'CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream', 'description': 'Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.\n\nCD07805/47 (Br) placebo gel\n\nCD5024 (IVM) placebo cream'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.0', 'spread': '14.8', 'groupId': 'BG000'}, {'value': '48.0', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '50.0', 'spread': '14.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2015-11-24', 'resultsFirstSubmitDate': '2017-09-19', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-19', 'studyFirstPostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):", 'timeFrame': 'week 12/Hour 3', 'description': 'Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rosacea']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n1. Male or female subjects age 18 years or older;\n2. Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face;\n3. Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored 3 or 4 according to Clinician's Erythema Assessment \\[CEA\\]);\n4. Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to the Investigator's Global Assessment \\[IGA\\]);\n5. Female subjects of childbearing potential with a negative urine pregnancy test (UPT);\n6. Female subjects of childbearing potential must practice a highly effective method of contraception during the study;\n7. Females subjects of non-childbearing potential;\n\nMain Exclusion Criteria:\n\n1. Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea;\n2. Subjects with more than 2 nodules of rosacea on the face;\n3. Subjects with any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or with optimal participation in the study or would present a significant risk to the subject;\n4. Subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;"}, 'identificationModule': {'nctId': 'NCT02616250', 'acronym': 'MOSAIC', 'briefTitle': 'MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'Efficacy and Safety of Ivermectin 1% Topical Cream Associated With Brimonidine 0.33% Topical Gel in the Treatment of Moderate to Severe Rosacea', 'orgStudyIdInfo': {'id': 'RD.03.SPR.105069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream', 'description': 'Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.\n\nHalf group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.', 'interventionNames': ['Drug: Brimonidine 0.33% gel (Br)', 'Other: CD07805/47 (Br) placebo gel', 'Drug: Ivermectin 1% cream (IVM)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream', 'description': 'Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.', 'interventionNames': ['Other: CD07805/47 (Br) placebo gel', 'Other: CD5024 (IVM) placebo cream']}], 'interventions': [{'name': 'Brimonidine 0.33% gel (Br)', 'type': 'DRUG', 'armGroupLabels': ['Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream']}, {'name': 'CD07805/47 (Br) placebo gel', 'type': 'OTHER', 'armGroupLabels': ['Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream', 'CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream']}, {'name': 'Ivermectin 1% cream (IVM)', 'type': 'DRUG', 'armGroupLabels': ['Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream']}, {'name': 'CD5024 (IVM) placebo cream', 'type': 'OTHER', 'armGroupLabels': ['CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Pflugerville', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.43937, 'lon': -97.62}}, {'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'city': 'Richmond Hill', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}