Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-02 @ 11:25 PM
Study NCT ID:
NCT03014635
Status:
COMPLETED
Last Update Posted:
2022-07-21
First Post:
2016-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], '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': 'tgross@revance.com', 'phone': '510-742-3400', 'title': 'Todd Gross, PhD, VP Data Science, Interim Head of Clinical Development', 'organization': 'Revance Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': 'With respect to any proposed publication or disclosure of the results of the Study, the Study Center and Investigator shall submit to Revance a copy of the proposed publication or disclosure at least sixty (60) days prior to the submission thereof for publication or disclosure to a third party: (i) to provide Revance with the opportunity to review and comment on the contents thereof, and (ii) to identify any Confidential Information to be deleted from the proposed publication or disclosure.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected throughout the entire study, up to 36 weeks', 'description': 'Adverse event incidence rates were based on the Safety population which includes 205 subjects exposed to DaxibotulinumtoxinA 40 units and 101 subjects who received placebo. Note 1 subject randomized to placebo was treated with DaxibotulinumtoxinA.', 'eventGroups': [{'id': 'EG000', 'title': 'DaxibotulinumtoxinA 40 Units', 'description': 'Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection\n\nBotulinum Toxins, Type A: Intramuscular injection', 'otherNumAtRisk': 205, 'deathsNumAtRisk': 205, 'otherNumAffected': 30, 'seriousNumAtRisk': 205, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Biological/Vaccine: Placebo Intramuscular injection\n\nPlacebo: Intramuscular injection', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 5, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Uterine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Leiomyosarcoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine leiomyosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DaxibotulinumtoxinA 40 Units', 'description': 'Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection\n\nBotulinum Toxins, Type A: Intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Biological/Vaccine: Placebo Intramuscular injection\n\nPlacebo: Intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '74.0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e., none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments', 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population'}, {'type': 'SECONDARY', 'title': 'The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaxibotulinumtoxinA 40 Units', 'description': 'Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection\n\nBotulinum Toxins, Type A: Intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000', 'lowerLimit': '142', 'upperLimit': '168'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0-36 weeks', 'description': 'The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaxibotulinumtoxinA 40 Units', 'description': 'Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection\n\nBotulinum Toxins, Type A: Intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000', 'lowerLimit': '169', 'upperLimit': '196'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0-36 weeks', 'description': 'The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DaxibotulinumtoxinA 40 Units', 'description': 'Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection\n\nBotulinum Toxins, Type A: Intramuscular injection'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Biological/Vaccine: Placebo Intramuscular injection\n\nPlacebo: Intramuscular injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '191'}, {'groupId': 'FG001', 'numSubjects': '93'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'preAssignmentDetails': 'Outpatient, male or non-pregnant, non-nursing females, 18-75 years of age, and in good general health with moderate (2) or severe (3) glabellar lines during maximum frown based on the IGA-FWS and PFWS'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '306', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DaxibotulinumtoxinA 40 Units', 'description': 'Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection\n\nBotulinum Toxins, Type A: Intramuscular injection'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Biological/Vaccine: Placebo Intramuscular injection\n\nPlacebo: Intramuscular injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.6', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '73'}, {'value': '50.5', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '75'}, {'value': '49.9', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or not reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '306', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent to treat population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-07', 'size': 979145, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-02-15T19:46', 'hasProtocol': True}, {'date': '2017-11-21', 'size': 647695, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-15T19:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'dispFirstSubmitDate': '2019-09-13', 'completionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-29', 'studyFirstSubmitDate': '2016-12-22', 'dispFirstSubmitQcDate': '2019-09-20', 'resultsFirstSubmitDate': '2022-02-15', 'studyFirstSubmitQcDate': '2017-01-05', 'dispFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-29', 'studyFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales', 'timeFrame': 'Week 4', 'description': 'Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e., none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments'}], 'secondaryOutcomes': [{'measure': 'The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group', 'timeFrame': '0-36 weeks', 'description': 'The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.'}, {'measure': 'The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group', 'timeFrame': '0-36 weeks', 'description': 'The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glabellar lines, frown lines'], 'conditions': ['Glabellar Frown Lines']}, 'referencesModule': {'references': [{'pmid': '31791824', 'type': 'DERIVED', 'citation': 'Bertucci V, Solish N, Kaufman-Janette J, Yoelin S, Shamban A, Schlessinger J, Snyder D, Gallagher C, Liu Y, Shears G, Rubio RG. DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). J Am Acad Dermatol. 2020 Apr;82(4):838-845. doi: 10.1016/j.jaad.2019.06.1313. Epub 2019 Nov 29.'}, {'pmid': '31609882', 'type': 'DERIVED', 'citation': 'Carruthers JD, Fagien S, Joseph JH, Humphrey SD, Biesman BS, Gallagher CJ, Liu Y, Rubio RG; SAKURA 1 and SAKURA 2 Investigator Group; SAKURA 1 and SAKURA 2 Investigator Group includes the following. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2). Plast Reconstr Surg. 2020 Jan;145(1):45-58. doi: 10.1097/PRS.0000000000006327.'}]}, 'descriptionModule': {'briefSummary': 'This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe frown lines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide written informed consent including authorization to release health information\n* Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale\n* Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity (PFWS) scale\n* Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial\n\nExclusion Criteria:\n\n* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis\n* Active skin disease, infections or inflammation at the injection sites\n* Plan to receive botulinum toxin type A anywhere in the face through the duration of the study\n* History of allergy or sensitivity to any botulinum toxin preparations or to any component of the test article\n* Current enrollment in an investigational drug or device trial or participation in such a trial within the last 30 days prior to screening through end of trial'}, 'identificationModule': {'nctId': 'NCT03014635', 'briefTitle': 'Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Revance Therapeutics, Inc.'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (SAKURA-2)', 'orgStudyIdInfo': {'id': '1620302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DaxibotulinumtoxinA 40 units', 'description': 'Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection', 'interventionNames': ['Biological: Botulinum Toxins, Type A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Biological/Vaccine: Placebos Intramuscular injection', 'interventionNames': ['Biological: Placebos']}], 'interventions': [{'name': 'Botulinum Toxins, Type A', 'type': 'BIOLOGICAL', 'otherNames': ['DaxibotulinumtoxinA'], 'description': 'Intramuscular injection', 'armGroupLabels': ['DaxibotulinumtoxinA 40 units']}, {'name': 'Placebos', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection', 'armGroupLabels': ['Placebo']}]}, 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'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Revance Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}