Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-02-28 @ 8:24 AM
Study NCT ID:
NCT03732833
Status:
COMPLETED
Last Update Posted:
2023-07-17
First Post:
2018-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aab005@medytox.com', 'phone': '+82-2-6901-5424', 'title': 'Young Ryu', 'organization': 'Medytox Inc.'}, 'certainAgreement': {'otherDetails': "General research agreement between the sponsor and PI's that includes a confidentiality section that includes a statement that the sponsor is and shall remain the exclusive owner of 'Information'. ) 'Information' shall include, but shall not be limited to, protocols, trade secrets, know-how, formulations, inventions, techniques, equipment, data and results.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)', 'description': 'Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo was injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 34, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.', 'otherNumAtRisk': 171, 'deathsNumAtRisk': 171, 'otherNumAffected': 60, 'seriousNumAtRisk': 171, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the LCL and MT10109L 20U into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.', 'otherNumAtRisk': 168, 'deathsNumAtRisk': 168, 'otherNumAffected': 74, 'seriousNumAtRisk': 168, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}], 'seriousEvents': [{'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Colitis microscopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Allergy to arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Face injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}, {'term': 'Abortion induced [F]', 'notes': 'Calculated with respect to number of Female participants at risk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of LCL Severity at Maximum Smile at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.\n\n.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'The outcome measured is the percentage of participants who had a ≥2-grade improvement from baseline LCL severity at maximum smile according to investigator and participant FWS ratings at Day 30.\n\nBoth the INVESTIGATOR AND PARTICIPANT evaluate the LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary endpoint measurements were carried out using the Intent-To-Treat (ITT) analysis set, which was defined as all participants who were randomized. Multiple imputation method was used for missing variables in primary efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale With Photonumeric Guide (FWS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Line (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': "The outcome here only considers the INVESTIGATOR assessments (excludes the participant assessment). The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. A Responder was defined as one achieving a ≥2-grade improvement from baseline at maximum smile at Day 30.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All secondary efficacy analyses were carried out using the Intent-To-Treat (ITT) analysis subset, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.'}, {'type': 'SECONDARY', 'title': 'The Duration of Lateral Canthal Lines (LCL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in LCL Severity at Maximum Smile at Day 30 According to Investigator Assessments Using the FWS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the LCL and MT10109L 20U into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '113', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '121'}, {'value': '93', 'groupId': 'OG002', 'lowerLimit': '89', 'upperLimit': '118'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (first treatment) to Day 180', 'description': "The investigator evaluates the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All secondary efficacy analyses were carried out using the Intent-To-Treat (ITT) analysis subset, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data. The participant analyzed here corresponds to the responders in Outcome 2.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Lateral Canthal Lines (LCL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 60', 'description': 'The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All secondary efficacy analyses were carried out using the Intent-To-Treat (ITT) analysis set or subset, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': "The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.\n\nAmong Participants Who Were Rated At least Mild at Rest at Baseline, where a Responder was Defined as Achieving a ≥1-grade Improvement from Baseline at Day 30. The outcome measured here is the proportion of participants who achieved a ≥1-grade improvement from baseline LCL severity at rest based on investigator FWS rating.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All secondary efficacy analyses were carried out using the Intent-To-Treat (ITT) analysis subset, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the LCL and MT10109L 20U into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'AEs that started or worsen after the first dose of study intervention and within 30 days after the last dose.', 'description': 'This section focuses primarily on TEAEs, i.e., AEs that started or worsened after the first dose of study intervention and within 30 days after the last dose. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All safety analyses were carried out using the Safety population set or subset, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Systolic Blood Pressure (BP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '11.60', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '12.29', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '13.67', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is the mean change in Systolic BP from baseline to study exit.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Diastolic Blood Pressure (BP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '8.61', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '8.34', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '9.28', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is the mean change in Diastolic BP from baseline to study exit.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '10.54', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '11.34', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is the mean change in Pulse Rate from baseline to study exit.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.04', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '2.47', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is the mean change in Respiratory Rate from baseline to study exit.', 'unitOfMeasure': 'breaths/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the LCL and MT10109L 20U into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '10.34', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '9.35', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '8.34', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is a mean change in mean heart rate from baseline to study exit.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the LCL and MT10109L 20U into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '9.36', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '12.37', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '11.09', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is a mean change in PR interval from baseline to study exit.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the LCL and MT10109L 20U into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '6.16', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '5.35', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '8.06', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is a mean change in QRS duration from baseline to study exit.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the LCL and MT10109L 20U into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.6', 'spread': '25.07', 'groupId': 'OG000'}, {'value': '-10.4', 'spread': '21.96', 'groupId': 'OG001'}, {'value': '-9.2', 'spread': '21.26', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is a mean change in QT interval from baseline to study exit.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the LCL and MT10109L 20U into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '17.34', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '16.64', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '16.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is a mean change in QTcB interval from baseline to study exit.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the LCL and MT10109L 20U into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'spread': '14.21', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '13.57', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '13.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is a mean change in QTcF interval from baseline to study exit.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the LCL and MT10109L 20U into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.6', 'spread': '137.27', 'groupId': 'OG000'}, {'value': '-53.0', 'spread': '120.85', 'groupId': 'OG001'}, {'value': '-35.0', 'spread': '114.66', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is a mean change in RR interval from baseline to study exit.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Binding and Neutralizing Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'OG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the LCL and MT10109L 20U into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 360', 'description': 'Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'FG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'FG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '171'}, {'comment': 'The number of participants in the Efficacy set = 167; The number of participants in the Safety set = 168', 'groupId': 'FG002', 'numSubjects': '167'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '138'}, {'groupId': 'FG002', 'numSubjects': '150'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Covid-19 related and other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Overall, 602 participants were screened, 424 participants were analyzed in ITT set and 425 participants were analyzed in Safety set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}, {'value': '424', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'BG001', 'title': 'MT10109L 24U + Placebo', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.\n\n.'}, {'id': 'BG002', 'title': 'MT10109L 24U + MT10109L 20U', 'description': 'MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '393', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.6', 'spread': '12.32', 'groupId': 'BG000'}, {'value': '47.7', 'spread': '11.56', 'groupId': 'BG001'}, {'value': '49.1', 'spread': '10.37', 'groupId': 'BG002'}, {'value': '48.5', 'spread': '11.26', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}, {'value': '355', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '398', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}, {'value': '405', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '424 participants were included in the ITT population (86 in the Placebo; 171 in the MT10109L 24 U group and 167 participants in the MT10109L 44U group)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-30', 'size': 5719823, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_004.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-20T18:20', 'hasProtocol': True}, {'date': '2020-11-18', 'size': 1819336, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_006.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-12T11:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 425}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'dispFirstSubmitDate': '2021-03-03', 'completionDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2018-11-05', 'resultsFirstSubmitDate': '2023-03-02', 'studyFirstSubmitQcDate': '2018-11-05', 'dispFirstPostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-12', 'studyFirstPostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of LCL Severity at Maximum Smile at Day 30', 'timeFrame': 'Day 30', 'description': 'The outcome measured is the percentage of participants who had a ≥2-grade improvement from baseline LCL severity at maximum smile according to investigator and participant FWS ratings at Day 30.\n\nBoth the INVESTIGATOR AND PARTICIPANT evaluate the LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline.'}], 'secondaryOutcomes': [{'measure': 'The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale With Photonumeric Guide (FWS)', 'timeFrame': 'Day 30', 'description': "The outcome here only considers the INVESTIGATOR assessments (excludes the participant assessment). The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. A Responder was defined as one achieving a ≥2-grade improvement from baseline at maximum smile at Day 30."}, {'measure': 'The Duration of Lateral Canthal Lines (LCL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in LCL Severity at Maximum Smile at Day 30 According to Investigator Assessments Using the FWS', 'timeFrame': 'Day 1 (first treatment) to Day 180', 'description': "The investigator evaluates the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe."}, {'measure': 'The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Lateral Canthal Lines (LCL)', 'timeFrame': 'Day 60', 'description': 'The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.'}, {'measure': 'The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS)', 'timeFrame': 'Day 30', 'description': "The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.\n\nAmong Participants Who Were Rated At least Mild at Rest at Baseline, where a Responder was Defined as Achieving a ≥1-grade Improvement from Baseline at Day 30. The outcome measured here is the proportion of participants who achieved a ≥1-grade improvement from baseline LCL severity at rest based on investigator FWS rating."}, {'measure': 'Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs)', 'timeFrame': 'AEs that started or worsen after the first dose of study intervention and within 30 days after the last dose.', 'description': 'This section focuses primarily on TEAEs, i.e., AEs that started or worsened after the first dose of study intervention and within 30 days after the last dose. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.'}, {'measure': 'Mean Change From Baseline in Systolic Blood Pressure (BP)', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is the mean change in Systolic BP from baseline to study exit.'}, {'measure': 'Mean Change From Baseline in Diastolic Blood Pressure (BP)', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is the mean change in Diastolic BP from baseline to study exit.'}, {'measure': 'Mean Change From Baseline in Pulse Rate', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is the mean change in Pulse Rate from baseline to study exit.'}, {'measure': 'Mean Change From Baseline in Respiratory Rate', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is the mean change in Respiratory Rate from baseline to study exit.'}, {'measure': 'Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is a mean change in mean heart rate from baseline to study exit.'}, {'measure': 'Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is a mean change in PR interval from baseline to study exit.'}, {'measure': 'Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is a mean change in QRS duration from baseline to study exit.'}, {'measure': 'Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is a mean change in QT interval from baseline to study exit.'}, {'measure': 'Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is a mean change in QTcB interval from baseline to study exit.'}, {'measure': 'Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is a mean change in QTcF interval from baseline to study exit.'}, {'measure': 'Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval', 'timeFrame': 'Baseline to Day 360', 'description': 'The outcome reported here is a mean change in RR interval from baseline to study exit.'}, {'measure': 'Number of Participants With Binding and Neutralizing Antibodies', 'timeFrame': 'Baseline to Day 360', 'description': 'Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lateral Canthal Lines', 'Glabellar Lines']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of MT10109L for the treatment of lateral canthal lines (LCL) with or without concurrent treatment of glabellar lines (GL) in participants with moderate to severe LCL and GL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.\n\nExclusion Criteria:\n\n* Known immunization or hypersensitivity to any botulinum toxin serotype.\n* Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.\n* History of facial nerve palsy.\n* Any uncontrolled systemic disease.\n* Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention).\n* Anticipated need for surgery or overnight hospitalization during the study.\n* Prior exposure to botulinum toxin of any serotype for any reason.\n* Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid \\[blepharoplasty\\] and/or eyebrow surgery).\n* Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation.\n* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.\n* Females who are pregnant, nursing, or planning a pregnancy during the study.\n* Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.'}, 'identificationModule': {'nctId': 'NCT03732833', 'briefTitle': 'MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medy-Tox'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines', 'orgStudyIdInfo': {'id': 'MT10109L-006'}, 'secondaryIdInfos': [{'id': '2014-005302-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MT10109L Dose 1 + Placebo', 'description': 'MT10109L Dose 1 will be injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.', 'interventionNames': ['Drug: MT10109L', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MT10109L Dose 1 + MT10109L Dose 2', 'description': 'MT10109L Dose 1 will be injected into the LCL and MT10109L Dose 2 into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.', 'interventionNames': ['Drug: MT10109L']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo will be injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MT10109L', 'type': 'DRUG', 'otherNames': ['NivobotulinumtoxinA'], 'description': 'MT10109L will be injected into either the LCL, or both the LCL and GL.', 'armGroupLabels': ['MT10109L Dose 1 + MT10109L Dose 2', 'MT10109L Dose 1 + Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be injected into either the GL, or both the LCL and GL.', 'armGroupLabels': ['MT10109L Dose 1 + Placebo', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85255-4134', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clear Dermatology & Aesthetics Center', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92075-2228', 'city': 'Solana Beach', 'state': 'California', 'country': 'United States', 'facility': 'Art of Skin MD', 'geoPoint': {'lat': 32.99115, 'lon': -117.27115}}, {'zip': '34209-5642', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Susan H. Weinkle, MD', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '70130-4353', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Etre Cosmetic Dermatology and Laser Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '10028', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Dermatology and Laser Surgery Center of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Skin Search of Rochester Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27612-8106', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'M3 Wake Research Inc.', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28403', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wilmington Dermatology Center', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '43016', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Aventiv Research Inc.', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '78746-4720', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Westlake Dermatology & Cosmetic Surgery - Westlake', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': 'V5Z 4E1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Jean Carruthers Cosmetic Surgery Inc.', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6H 4E1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pacific Derm', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L7N 3N2', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dermetics Cosmetic Dermatology', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'L4B 1A5', 'city': 'Richmond Hill', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Nectar Research Group Inc.', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'zip': '64283', 'city': 'Darmstadt', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Rosenpark Research', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'zip': '50996', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Hautzentrum Koln - Cologne Dermatology', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '80333', 'city': 'München', 'country': 'Germany', 'facility': 'Hautok and Hautok-cosmetics', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '61440', 'city': 'Oberursel', 'country': 'Germany', 'facility': 'MediCorium Zentrum fuer Dermatologie und Aesthetik', 'geoPoint': {'lat': 50.20731, 'lon': 8.57747}}, {'zip': '42287', 'city': 'Wuppertal', 'country': 'Germany', 'facility': 'CentroDerm GmbH', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}], 'overallOfficials': [{'name': 'SangMi Park', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medytox Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medy-Tox', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}