Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-03-09 @ 4:28 AM
Study NCT ID:
NCT02261467
Status:
COMPLETED
Last Update Posted:
2019-01-08
First Post:
2014-10-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brandstetter_tanya@Allergan.com', 'phone': '714-246-2567', 'title': 'Tanya Brandstetter', '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': {'description': 'The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess adverse events and serious adverse events. Subjects randomized to receive placebo in Period 1 who subsequently received open-label onabotulinumtoxinA in Period 2 are included in the onabotulinumtoxinA group for the Safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Followed by OnabotulinumtoxinA in Period 2', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.', 'otherNumAtRisk': 100, 'otherNumAffected': 12, 'seriousNumAtRisk': 100, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.', 'otherNumAtRisk': 374, 'otherNumAffected': 92, 'seriousNumAtRisk': 374, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 374, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 374, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 374, 'numAffected': 43}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 374, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 374, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 374, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 374, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 374, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation", 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Followed by OnabotulinumtoxinA in Period 2', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'comment': 'Zero incidences; therefore, CI not applicable', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '61.4', 'groupId': 'OG001', 'lowerLimit': '55.8', 'upperLimit': '67.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 30', 'description': "The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported.", 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: all randomized subjects'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Followed by OnabotulinumtoxinA in Period 2', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '4.7'}, {'value': '94.1', 'groupId': 'OG001', 'lowerLimit': '91.4', 'upperLimit': '96.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30', 'description': 'The Investigator assessed the severity of the subject\'s forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with a score of "none" and "mild" are reported.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: all randomized subjects with a score of "none" and "mild" on the FWS at maximum eyebrow elevation'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest", 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Followed by OnabotulinumtoxinA in Period 2', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '27.8'}, {'value': '85.6', 'groupId': 'OG001', 'lowerLimit': '81.5', 'upperLimit': '89.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 30', 'description': "The Investigator assessed the severity of the subject's forehead lines at rest using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 1-grade improvement assessed by the Investigator are reported.", 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: all randomized subjects with at least a 1-grade improvement assessed by the Investigator on the FWS at rest'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Followed by OnabotulinumtoxinA in Period 2', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '3.0'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '86.9', 'upperLimit': '93.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 60', 'description': 'The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. Item 5 on the FLSQ asks "How satisfied are you with the effect your treatment had on your facial lines?" Responses included: very satisfied, mostly satisfied, neither satisfied or dissatisfied, mostly dissatisfied, or very dissatisfied. The percentage of subjects reporting a score of mostly satisfied or very satisfied with treatment are reported.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: all randomized subjects with data reported at this time point'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Followed by OnabotulinumtoxinA in Period 2', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '27.0'}, {'value': '73.9', 'groupId': 'OG001', 'lowerLimit': '68.6', 'upperLimit': '79.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 30', 'description': "The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. The Impact Domain measures the subject's appearance-related and emotional impacts of treatment and is composed of 5 questions with a possible range of scores from 0 (worst) to 100 (best), using a transformed scale. Only subjects with baseline scores ≥ 20 are included in the analysis.", 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: all randomized subjects with baseline scores ≥ 20 on the Impact Domain of the FLSQ'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire©', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Followed by OnabotulinumtoxinA in Period 2', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '17.8'}, {'value': '77.2', 'groupId': 'OG001', 'lowerLimit': '72.0', 'upperLimit': '82.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 30', 'description': 'The FLO-11 assess the subject\'s psychological and appearance-related impacts associated with facial lines. Item 4 is "I look older than my actual age because of my facial lines" with a range of possible scores from 0 = not at all to 10 = very much. Only subjects with baseline scores ≥ 3 are included in the analysis.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: all randomized subjects with baseline scores ≥ 3 on Item 4 of the FLO-11'}, {'type': 'SECONDARY', 'title': 'Time to Retreatment Eligibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Followed by OnabotulinumtoxinA in Period 2', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'spread': '52.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 Months', 'description': 'Time to retreatment eligibility is defined as the number of days from treatment cycle 1 injection to the return to an Investigator FWS rating of moderate or severe at maximum eyebrow elevation. The FWS is a 4-grade scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Only subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation on Day 30 are included in the analysis.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: all randomized subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Followed by OnabotulinumtoxinA in Period 2', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.'}, {'id': 'FG001', 'title': 'OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '290'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '253'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Enrolled in Error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 421 subjects were enrolled in the study, of these, 30 subjects were excluded from the data analyses at one site. The participant flow reflects all subjects included in the data analyses.', 'preAssignmentDetails': 'Subjects were randomized to either placebo or onabotulinumtoxinA in Period 1. Subjects randomized to receive placebo in Period 1 who subsequently received open-label onabotulinumtoxinA in Period 2 are also included in the onabotulinumtoxinA group for the Safety analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '290', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Followed by OnabotulinumtoxinA in Period 2', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.'}, {'id': 'BG001', 'title': 'OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 421}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'dispFirstSubmitDate': '2016-06-03', 'completionDateStruct': {'date': '2016-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-18', 'studyFirstSubmitDate': '2014-10-03', 'dispFirstSubmitQcDate': '2016-06-03', 'resultsFirstSubmitDate': '2017-05-30', 'studyFirstSubmitQcDate': '2014-10-07', 'dispFirstPostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-30', 'studyFirstPostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation", 'timeFrame': 'Baseline, Day 30', 'description': "The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported."}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation', 'timeFrame': 'Day 30', 'description': 'The Investigator assessed the severity of the subject\'s forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with a score of "none" and "mild" are reported.'}, {'measure': "Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest", 'timeFrame': 'Baseline, Day 30', 'description': "The Investigator assessed the severity of the subject's forehead lines at rest using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 1-grade improvement assessed by the Investigator are reported."}, {'measure': 'Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5', 'timeFrame': 'Day 60', 'description': 'The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. Item 5 on the FLSQ asks "How satisfied are you with the effect your treatment had on your facial lines?" Responses included: very satisfied, mostly satisfied, neither satisfied or dissatisfied, mostly dissatisfied, or very dissatisfied. The percentage of subjects reporting a score of mostly satisfied or very satisfied with treatment are reported.'}, {'measure': 'Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points', 'timeFrame': 'Baseline, Day 30', 'description': "The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. The Impact Domain measures the subject's appearance-related and emotional impacts of treatment and is composed of 5 questions with a possible range of scores from 0 (worst) to 100 (best), using a transformed scale. Only subjects with baseline scores ≥ 20 are included in the analysis."}, {'measure': 'Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire©', 'timeFrame': 'Baseline, Day 30', 'description': 'The FLO-11 assess the subject\'s psychological and appearance-related impacts associated with facial lines. Item 4 is "I look older than my actual age because of my facial lines" with a range of possible scores from 0 = not at all to 10 = very much. Only subjects with baseline scores ≥ 3 are included in the analysis.'}, {'measure': 'Time to Retreatment Eligibility', 'timeFrame': '12 Months', 'description': 'Time to retreatment eligibility is defined as the number of days from treatment cycle 1 injection to the return to an Investigator FWS rating of moderate or severe at maximum eyebrow elevation. The FWS is a 4-grade scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Only subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation on Day 30 are included in the analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Forehead Rhytides', 'Glabellar Rhytides']}, 'referencesModule': {'references': [{'pmid': '30096106', 'type': 'BACKGROUND', 'citation': 'De Boulle K, Werschler WP, Gold MH, Bruce S, Sattler G, Ogilvie P, Street J, Larsen KE, Yushmanova I, Lei X, Lee E, Vitarella D, Mao C. Phase 3 Study of OnabotulinumtoxinA Distributed Between Frontalis, Glabellar Complex, and Lateral Canthal Areas for Treatment of Upper Facial Lines. Dermatol Surg. 2018 Nov;44(11):1437-1448. doi: 10.1097/DSS.0000000000001612.'}]}, 'descriptionModule': {'briefSummary': 'This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and glabellar facial rhytides (frown lines).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe forehead and glabellar lines\n* Willing to have facial photos taken\n\nExclusion Criteria:\n\n* Prior exposure to botulinum toxin of any serotype for any indication\n* Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study, other than study treatment\n* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis\n* Any facial resurfacing laser or light treatment, microdermabrasion, or superficial peels in the past 3 months\n* Any medium depth or deep depth facial chemical peels; facial skin resurfacing; or permanent facial make-up in the past 6 months\n* Any nonpermanent soft tissue fillers, or treatment with oral retinoids in the past year\n* Prior face lift, thread lift, eyebrow lift, or related procedures (eg, eyelid and/or eyebrow surgery)\n* Prior facial treatment with permanent soft tissue fillers, synthetic implants (eg, Gore-Tex®), and/or fat transplantation'}, 'identificationModule': {'nctId': 'NCT02261467', 'briefTitle': 'A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Forehead and Glabellar Facial Rhytides', 'orgStudyIdInfo': {'id': '191622-142'}, 'secondaryIdInfos': [{'id': '2014-001860-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.', 'interventionNames': ['Biological: OnabotulinumtoxinA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo followed by OnabotulinumtoxinA in Period 2', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'OnabotulinumtoxinA', 'type': 'BIOLOGICAL', 'otherNames': ['BOTOX® Cosmetic', 'botulinum toxin Type A'], 'description': 'OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments.', 'armGroupLabels': ['OnabotulinumtoxinA']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1.', 'armGroupLabels': ['Placebo followed by OnabotulinumtoxinA in Period 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Total Skin and Beauty Dermatology Center, PC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Advanced Research Associates', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Science Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'facility': 'About Skin Dermatology and DermSurgery, PC', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '33431', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Steven Fagien, MD, PA', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Laser & Skin Surgery Center of Indiana', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Coleman Center For Cosmetic Dermatologic Surgery', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '48322', 'city': 'West Bloomfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Medical Center', 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'NW Dermatology and Research Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': 'V5Z 4E1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Carruthers Dermatology Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V5Z 4E1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Shannon Humphrey, Inc.', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V5Z 4E1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Jean Carruthers Cosmetic Dermatology', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5R 3N8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sweat Clinics of Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3Z 1B7', 'city': 'Westmount', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Arthur Swift Research, Inc.', 'geoPoint': {'lat': 45.48341, 'lon': -73.59918}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Aesthetic Surgery Ireland', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Beacon Face and Dermatology Clinic', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}