Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-28 @ 4:48 AM
Study NCT ID:
NCT05089357
Status:
COMPLETED
Last Update Posted:
2025-07-09
First Post:
2021-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese Origin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C542869', 'term': 'abobotulinumtoxinA'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reception.seupp@galderma.com', 'phone': '+46184749000', 'title': 'Clinical Scientist', 'organization': 'Q-Med AB'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study up to end of study (Up to 20 Months)', 'description': 'The Safety Set included all participants who received at least 1 dose of study treatment and for whom actual data on safety endpoints were available.', 'eventGroups': [{'id': 'EG000', 'title': 'AbobotulinumtoxinA', 'description': 'Participants with moderate to severe Glabellar lines (GL) received AbobotulinumtoxinA (Dysport®), total dose of 50 U (0.25 milliliter \\[mL\\] total; 10 U \\[0.05 mL per injection site\\] of study drug into each of the 5 injection sites) at Visits 1, 3, and 5.', 'otherNumAtRisk': 250, 'deathsNumAtRisk': 250, 'otherNumAffected': 107, 'seriousNumAtRisk': 250, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'COVID-19', 'notes': 'Events were not related to the product or injection procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Upper respiratory tract infection', 'notes': 'Events were not related to the product or injection procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 49}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'seriousEvents': [{'term': 'Severe leiomyoma', 'notes': 'Event was not related to the product or injection procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AbobotulinumtoxinA', 'description': 'Participants with moderate to severe GL received a total dose of AbobotulinumtoxinA (Dysport®), 50 U (0.25 mL total; 10 U \\[0.05 mL per injection site\\] of study drug into 5 injection sites intramuscularly: 2 injections into each corrugator muscle and 1 injection into the procerus muscle) at Visits 1, 3, and 5.'}], 'classes': [{'title': 'Very Satisfied', 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000', 'lowerLimit': '64.3', 'upperLimit': '77.2'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000', 'lowerLimit': '22.8', 'upperLimit': '35.7'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'comment': '95 percent (%) confidence interval could not be calculated due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Very Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'comment': '95 percent (%) confidence interval could not be calculated due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 14', 'description': 'The participant\'s satisfaction with the treatment was assessed using a subject satisfaction questionnaire. At Visit 6 (that is., three weeks, after the 3rd injection) participants were asked "What is your overall satisfaction after three treatment cycles with Dysport?" Participant\'s response options were noted as: Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Percentage of participants in each response category were reported here.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS was a subset of the FAS that included all participants who had evaluable primary efficacy endpoints, had overall good compliance, and had no major protocol deviations during the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Each Response Category for Overall Physician Satisfaction at Visit 6, Assessed by the Physician Satisfaction Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AbobotulinumtoxinA', 'description': 'Participants with moderate to severe GL received AbobotulinumtoxinA (Dysport®), total dose of 50 U (0.25 mL total; 10 U \\[0.05 mL per injection site\\] of study drug into each of the 5 injection sites) at Visits 1, 3, and 5.'}], 'classes': [{'title': 'Very Satisfied', 'categories': [{'measurements': [{'value': '68.1', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Very Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 14', 'description': 'The physician\'s satisfaction with the treatment was assessed using a physician satisfaction questionnaire. At Visit 6 (i.e., three weeks, after the 3rd injection) Physician were asked "What is your overall satisfaction after three treatment cycles with Dysport?" Physician response options were noted as: Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Percentage of participants in each response category for overall physician satisfaction were reported here. Physicians were not considered enrolled but did contribute to this assessment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS was a subset of the FAS that included all participants who had evaluable primary efficacy endpoints, had overall good compliance, and had no major protocol deviations during the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AbobotulinumtoxinA', 'description': 'Participants with moderate to severe GL received AbobotulinumtoxinA (Dysport®), total dose of 50 U (0.25 mL total; 10 U \\[0.05 mL per injection site\\] of study drug into each of the 5 injection sites) at Visits 1, 3, and 5.'}], 'classes': [{'title': 'How satisfied are you with aesthetic outcome in injected area after treatment: Very satisfied', 'categories': [{'measurements': [{'value': '53.0', 'groupId': 'OG000'}]}]}, {'title': 'How satisfied are you with aesthetic outcome in injected area after treatment:Satisfied', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000'}]}]}, {'title': 'How satisfied are you with aesthetic outcome in injected area after treatment:Dissatisfied', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'How satisfied are with aesthetic outcome in injected area after treatment:Very dissatisfied', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'How satisfied were you with comfort of injection: Very satisfied', 'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000'}]}]}, {'title': 'How satisfied were you with comfort of injection: Satisfied', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}]}]}, {'title': 'How satisfied were you with comfort of injection: Dissatisfied', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'How satisfied were you with comfort of injection: Very Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 20', 'description': 'The participant\'s satisfaction with the treatment was assessed using a subject satisfaction questionnaire. Participants were asked "How satisfied with the aesthetic outcome in the Injected area after treatment" and "How satisfied were you with the comfort of the injection" Participant\'s response options were noted as: Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Percentage of participants in each response category were reported here.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS was a subset of the FAS that included all participants who had evaluable primary efficacy endpoints, had overall good compliance, and had no major protocol deviations during the study. Here" overall number of participants analyzed signified" participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AbobotulinumtoxinA', 'description': 'Participants with moderate to severe Glabellar lines (GL) received a total dose of AbobotulinumtoxinA (Dysport®), 50 Units (U) (0.25 milliliter \\[mL\\] total; 10 U \\[0.05 mL per injection site\\] of study drug into 5 injection sites intramuscularly: 2 injections into each corrugator muscle and 1 injection into the procerus muscle) at Visits 1, 3, and 5.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}]}, {'type': 'Per Protocol Set (PPS)', 'comment': 'PPS was a subset of the Full Analysis Set (FAS) that included all participants who had evaluable primary efficacy endpoints, had overall good compliance, and had no major protocol deviations during the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '216'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Medical reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Due to completion of project, participants did not enter the follow-up window period and withdrew', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study was conducted in China from 11 November 2021 to 24 December 2023.', 'preAssignmentDetails': 'A total of 250 participants were enrolled and received study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AbobotulinumtoxinA', 'description': 'Participants with moderate to severe GL received a total dose of AbobotulinumtoxinA (Dysport®), 50 U (0.25 mL total; 10 U \\[0.05 mL per injection site\\] of study drug into 5 injection sites intramuscularly: 2 injections into each corrugator muscle and 1 injection into the procerus muscle) at Visits 1, 3, and 5.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'spread': '9.32', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '214', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '250', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Han (East Asian)', 'categories': [{'measurements': [{'value': '229', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '250', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'FAS included all participants who were screened, enrolled in the study, and treated at least once with study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-28', 'size': 1953512, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-17T04:52', 'hasProtocol': True}, {'date': '2024-03-15', 'size': 942156, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-17T04:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2021-09-27', 'resultsFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2021-10-10', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-17', 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire', 'timeFrame': 'Month 14', 'description': 'The participant\'s satisfaction with the treatment was assessed using a subject satisfaction questionnaire. At Visit 6 (that is., three weeks, after the 3rd injection) participants were asked "What is your overall satisfaction after three treatment cycles with Dysport?" Participant\'s response options were noted as: Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Percentage of participants in each response category were reported here.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants in Each Response Category for Overall Physician Satisfaction at Visit 6, Assessed by the Physician Satisfaction Questionnaire', 'timeFrame': 'Month 14', 'description': 'The physician\'s satisfaction with the treatment was assessed using a physician satisfaction questionnaire. At Visit 6 (i.e., three weeks, after the 3rd injection) Physician were asked "What is your overall satisfaction after three treatment cycles with Dysport?" Physician response options were noted as: Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Percentage of participants in each response category for overall physician satisfaction were reported here. Physicians were not considered enrolled but did contribute to this assessment.'}, {'measure': 'Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire', 'timeFrame': 'Month 20', 'description': 'The participant\'s satisfaction with the treatment was assessed using a subject satisfaction questionnaire. Participants were asked "How satisfied with the aesthetic outcome in the Injected area after treatment" and "How satisfied were you with the comfort of the injection" Participant\'s response options were noted as: Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Percentage of participants in each response category were reported here.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glabellar Lines']}, 'descriptionModule': {'briefSummary': 'This is a prospective, longitudinal, non-interventional, multi-center study to collect subject and physician satisfaction, and treatment experience with Dysport in real clinical practice in subjects of Chinese origin.', 'detailedDescription': 'Approximately 250 subjects are planned to be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female adult subjects up to 65 years of age with moderate to severe glabellar lines (GL)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female up to 65 years of age, and of Chinese origin.\n* Moderate (grade 2) or severe (grade 3) glabellar lines at max frown.\n* Prior to and independent of study, subject is seeking long term treatment of their glabellar lines.\n* Prior to and independent of the study participation, physician intended to treat the subject with Dysport.\n* Time and ability to complete the study and comply with instructions.\n* Understands the study requirements and signed the informed consent form (ICF)\n\nExclusion Criteria:\n\n* Hypersensitive to Dysport or its excipients.\n* Presence of contraindications to Dysport treatment as specified in the approved leaflet in China.\n* Subject is at risk for precautions, warnings, and/or contraindications to Dysport as specified in the approved leaflet in China.'}, 'identificationModule': {'nctId': 'NCT05089357', 'briefTitle': 'Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese Origin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Prospective, Non-interventional Study to Collect Subject and Physician Satisfaction During Long Term Treatment of Glabellar Lines With Dysport® in Subjects of Chinese Origin in Real Clinical Practice', 'orgStudyIdInfo': {'id': '05PF2009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AbobotulinumtoxinA', 'description': 'Participants with moderate to severe GL received a total dose of AbobotulinumtoxinA (Dysport®), 50 U (0.25 mL total; 10 U \\[0.05 mL per injection site\\] of study drug into 5 injection sites intramuscularly: 2 injections into each corrugator muscle and 1 injection into the procerus muscle) at Visits 1, 3, and 5.', 'interventionNames': ['Biological: AbobotulinumtoxinA']}], 'interventions': [{'name': 'AbobotulinumtoxinA', 'type': 'BIOLOGICAL', 'description': 'Participants received a total dose of AbobotulinumtoxinA (Dysport®), 50 U (0.25 mL total; 10 U \\[0.05 mL per injection site\\] of study drug into 5 injection sites intramuscularly.', 'armGroupLabels': ['AbobotulinumtoxinA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Hangzhou Yanshuyuerong medical cosmetology clinic', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Weiming Song', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hangzhou Yanshuyuerong medical cosmetology clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}