Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT02637232
Status:
COMPLETED
Last Update Posted:
2021-05-28
First Post:
2015-12-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mirvaso® Utilisation and Patient Satisfaction Evaluation (MUSE)
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'}], 'ancestors': [{'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephanie.leclerc@galderma.com', 'phone': '+33492386706', 'title': 'Stéphanie Leclerc', 'organization': 'Galderma'}, 'certainAgreement': {'otherDetails': "This is an agreement between the PI and sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Disclosure agreement is covered by a contract.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline (Day 0) up to study follow-up visit at Week 4 (Day 31).', 'description': 'Analysis was performed on safety population that comprised of subjects included and with at least a post-Baseline visit or information regarding the adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'Mirvaso® / Onreltea TM', 'description': 'Mirvaso® / Onreltea TM', 'otherNumAtRisk': 259, 'deathsNumAtRisk': 259, 'otherNumAffected': 61, 'seriousNumAtRisk': 259, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 36, 'numAffected': 32}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Skin burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 36, 'numAffected': 33}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Skin swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'AORTIC ECTASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'STENOSIS OF ILIACA EXTERNAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'RIVA STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirvaso® / Onreltea TM', 'description': 'Mirvaso® / Onreltea TM'}], 'classes': [{'categories': [{'title': 'Very satisfied', 'measurements': [{'value': '55', 'groupId': 'OG000'}]}, {'title': 'Somewhat satisfied', 'measurements': [{'value': '86', 'groupId': 'OG000'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '38', 'groupId': 'OG000'}]}, {'title': 'Somewhat dissatisfied', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}, {'title': 'Very dissatisfied', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on total population. Here, "Overall Number of Participants Analyzed" = participants with available data for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mirvaso® / Onreltea TM', 'description': 'Mirvaso® / Onreltea TM'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '246'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': "patient 's decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Mirvaso® / Onreltea TM', 'description': 'Mirvaso® / Onreltea TM'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '48.4', 'spread': '14.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '218', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of rosacea', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '7.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Previous therapies in the last 2 years', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Subject previously prescribed by Mirvaso', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Severity of facial erythema (by physician)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Mild', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '179', 'groupId': 'BG000'}]}, {'title': 'Severe', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Severity of facial erythema (by subject)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Mild', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '169', 'groupId': 'BG000'}]}, {'title': 'Severe', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Additional signs and Symptoms', 'classes': [{'title': 'Flushing present', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '250', 'groupId': 'BG000'}]}]}, {'title': 'Papules and Pustules', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}]}]}, {'title': 'Skin burning & stinging sensation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}]}]}, {'title': 'Rhinophyma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'Ocular manifestation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}, {'title': 'Telangiectasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '205', 'groupId': 'BG000'}]}]}, {'title': 'Other signs and symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Each subject can present several signs and symptoms. Here, number analyzed=participants with available data for specified categories.'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 301}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2015-12-16', 'resultsFirstSubmitDate': '2018-02-15', 'studyFirstSubmitQcDate': '2015-12-21', 'lastUpdatePostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-06', 'studyFirstPostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question', 'timeFrame': 'Week 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rosacea']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the level of satisfaction among patients to whom Mirvaso® / Onreltea TM (trade mark) is prescribed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient with persistent facial erythema of rosacea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients to whom the physician has already decided to prescribe Mirvaso® /OnrelteaTM according to package insert'}, 'identificationModule': {'nctId': 'NCT02637232', 'acronym': 'MUSE', 'briefTitle': 'Mirvaso® Utilisation and Patient Satisfaction Evaluation (MUSE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'Mirvaso® Utilisation and Patient Satisfaction Evaluation', 'orgStudyIdInfo': {'id': 'RD.03.SPR.104160'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mirvaso® / Onreltea TM', 'interventionNames': ['Other: Mirvaso® / Onreltea TM']}], 'interventions': [{'name': 'Mirvaso® / Onreltea TM', 'type': 'OTHER', 'armGroupLabels': ['Mirvaso® / Onreltea TM']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamilton', 'country': 'Canada', 'facility': 'Investigator site 1', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Chiltern International Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}