Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-03-06 @ 5:30 AM
Study NCT ID:
NCT01608659
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2012-05-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Observational Retrospective Study to Evaluate Treatment Patterns of Botulinum Toxin Type A
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'C545476', 'term': 'incobotulinumtoxinA'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Vice President Medical Affairs,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Botulinum Toxin Type A', 'description': 'Previous treatment with botulinum toxin Type A for treatment of facial lines', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Total Dose Per Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'Previous treatment with botulinum toxin Type A for treatment of facial lines'}], 'classes': [{'title': 'Treatment Period 1 (BOTOX®) N=34', 'categories': [{'measurements': [{'value': '49.2', 'spread': '12.77', 'groupId': 'OG000'}]}]}, {'title': 'Treatment Period 2 (Xeomin®) N=34', 'categories': [{'measurements': [{'value': '48.1', 'spread': '15.18', 'groupId': 'OG000'}]}]}, {'title': 'Treatment Period 3 (BOTOX®) N=16', 'categories': [{'measurements': [{'value': '45.8', 'spread': '4.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Months', 'description': 'Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.', 'unitOfMeasure': 'Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.'}, {'type': 'SECONDARY', 'title': 'Inter-Injection Interval Duration of Each Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'Previous treatment with botulinum toxin Type A for treatment of facial lines'}], 'classes': [{'title': 'Treatment Period 1 (BOTOX®) N=110', 'categories': [{'measurements': [{'value': '180.3', 'spread': '94.40', 'groupId': 'OG000', 'lowerLimit': '58', 'upperLimit': '623'}]}]}, {'title': 'Treatment Period 2 (Xeomin®) N=106', 'categories': [{'measurements': [{'value': '144.3', 'spread': '113.55', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '658'}]}]}, {'title': 'Treatment Period 3 (BOTOX®) N=76', 'categories': [{'measurements': [{'value': '176.9', 'spread': '91.43', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '639'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 Months', 'description': 'Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.'}, {'type': 'SECONDARY', 'title': 'Percent of Subjects Reporting Satisfaction With Treatment Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'Previous treatment with botulinum toxin Type A for treatment of facial lines'}], 'classes': [{'title': 'Treatment Period 1 (BOTOX®) N=80', 'categories': [{'measurements': [{'value': '99.0', 'spread': '6.68', 'groupId': 'OG000'}]}]}, {'title': 'Treatment Period 2 (Xeomin®) N=74', 'categories': [{'measurements': [{'value': '33.7', 'spread': '39.29', 'groupId': 'OG000'}]}]}, {'title': 'Treatment Period 3 (BOTOX®) N=67', 'categories': [{'measurements': [{'value': '90.3', 'spread': '17.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Months', 'description': 'Percent of subjects reporting satisfaction with treatment effects per chart notes.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Botulinum Toxin Type A', 'description': 'Previous treatment with botulinum toxin Type A for treatment of facial lines'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}]}], 'preAssignmentDetails': 'In this retrospective chart review study, subjects received botulinum toxin Type A (BOTOX®) in study-defined Treatment Periods 1 and 3, and botulinum toxin Type A (Xeomin®) in Treatment Period 2. Data were evaluated as available for each Treatment Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Botulinum Toxin Type A', 'description': 'Previous treatment with botulinum toxin Type A for treatment of facial lines'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '≥30 and <40 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '≥40 and <50 years', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': '≥50 and <60 years', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': '≥60 years', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2011-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2012-05-29', 'resultsFirstSubmitDate': '2012-06-25', 'studyFirstSubmitQcDate': '2012-05-29', 'lastUpdatePostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-06-25', 'studyFirstPostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Total Dose Per Treatment Period', 'timeFrame': '24 Months', 'description': 'Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.'}], 'secondaryOutcomes': [{'measure': 'Inter-Injection Interval Duration of Each Treatment Period', 'timeFrame': '24 Months', 'description': 'Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle.'}, {'measure': 'Percent of Subjects Reporting Satisfaction With Treatment Effects', 'timeFrame': '24 Months', 'description': 'Percent of subjects reporting satisfaction with treatment effects per chart notes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Facial Rhytides']}, 'referencesModule': {'references': [{'pmid': '23990584', 'type': 'BACKGROUND', 'citation': 'Banegas RA, Farache F, Rancati A, Chain M, Gallagher CJ, Chapman MA, Caulkins CA. The South American Glabellar Experience Study (SAGE): a multicenter retrospective analysis of real-world treatment patterns following the introduction of incobotulinumtoxinA in Argentina. Aesthet Surg J. 2013 Sep 1;33(7):1039-45. doi: 10.1177/1090820X13503475. Epub 2013 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type A for the treatment of facial lines.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects treated for glabellar lines (hyperfunctional facial lines) with botulinum toxin Type A', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously treated for glabellar lines (hyperfunctional facial lines) with botulinum toxin Type A preparation\n* Received 2 treatment cycles wtih botulinum toxin Type A (BOTOX®) prior to at least 1 treatment with botulinum toxin Type A (Xeomin®)\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01608659', 'briefTitle': 'An Observational Retrospective Study to Evaluate Treatment Patterns of Botulinum Toxin Type A', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'GMA-BTXC-10-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'botulinum toxin Type A', 'description': 'Previous treatment with botulinum toxin Type A for treatment of facial lines', 'interventionNames': ['Drug: botulinum toxin Type A']}], 'interventions': [{'name': 'botulinum toxin Type A', 'type': 'DRUG', 'otherNames': ['BOTOX®', 'Xeomin®'], 'description': 'Previous treatment with botulinum toxin Type A for treatment of facial lines', 'armGroupLabels': ['botulinum toxin Type A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}