Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-02-26 @ 6:36 AM
Study NCT ID:
NCT02261493
Status:
COMPLETED
Last Update Posted:
2017-07-25
First Post:
2014-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Efficacy Study of OnabotulinumtoxinA in Upper 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 AEs and SAEs. Subjects randomized to receive placebo in Period 1 who subsequently received open-label onabotulinumtoxinA Dose A in Period 2 are included in the onabotulinumtoxinA Dose A group for the Safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.', 'otherNumAtRisk': 156, 'otherNumAffected': 21, 'seriousNumAtRisk': 156, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'OnabotulinumtoxinA Dose B', 'description': 'OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.', 'otherNumAtRisk': 318, 'otherNumAffected': 90, 'seriousNumAtRisk': 318, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'OnabotulinumtoxinA Dose A', 'description': 'OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.', 'otherNumAtRisk': 746, 'otherNumAffected': 198, 'seriousNumAtRisk': 746, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 48}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 69}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}], 'seriousEvents': [{'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Post procedural inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Large intestine benign neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Malignant melanoma stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Squamous cell carcinoma of the tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Temporal lobe epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Tonsillectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 746, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', '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': '156', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA Dose B', 'description': 'OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}, {'id': 'OG002', 'title': 'OnabotulinumtoxinA Dose A', 'description': 'OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '1.9'}, {'value': '45.6', 'groupId': 'OG001', 'lowerLimit': '40.1', 'upperLimit': '51.1'}, {'value': '53.0', 'groupId': 'OG002', 'lowerLimit': '47.5', 'upperLimit': '58.6'}]}]}], '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': '156', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA Dose B', 'description': 'OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}, {'id': 'OG002', 'title': 'OnabotulinumtoxinA Dose A', 'description': 'OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '6.9'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '87.0', 'upperLimit': '93.5'}, {'value': '94.9', 'groupId': 'OG002', 'lowerLimit': '92.4', 'upperLimit': '97.3'}]}]}], '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': '150', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA Dose B', 'description': 'OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}, {'id': 'OG002', 'title': 'OnabotulinumtoxinA Dose A', 'description': 'OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '24.9'}, {'value': '85.2', 'groupId': 'OG001', 'lowerLimit': '81.2', 'upperLimit': '89.1'}, {'value': '84.8', 'groupId': 'OG002', 'lowerLimit': '80.8', 'upperLimit': '88.8'}]}]}], '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': '155', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA Dose B', 'description': 'OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}, {'id': 'OG002', 'title': 'OnabotulinumtoxinA Dose A', 'description': 'OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '6.0'}, {'value': '81.4', 'groupId': 'OG001', 'lowerLimit': '77.1', 'upperLimit': '85.7'}, {'value': '87.9', 'groupId': 'OG002', 'lowerLimit': '84.2', 'upperLimit': '91.5'}]}]}], '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': '152', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA Dose B', 'description': 'OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}, {'id': 'OG002', 'title': 'OnabotulinumtoxinA Dose A', 'description': 'OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000', 'lowerLimit': '13.4', 'upperLimit': '26.1'}, {'value': '61.0', 'groupId': 'OG001', 'lowerLimit': '55.5', 'upperLimit': '66.4'}, {'value': '76.1', 'groupId': 'OG002', 'lowerLimit': '71.3', 'upperLimit': '80.9'}]}]}], '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': '141', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '288', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA Dose B', 'description': 'OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}, {'id': 'OG002', 'title': 'OnabotulinumtoxinA Dose A', 'description': 'OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '14.9'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '61.2', 'upperLimit': '72.1'}, {'value': '77.1', 'groupId': 'OG002', 'lowerLimit': '72.2', 'upperLimit': '81.9'}]}]}], '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': '1', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA Dose B', 'description': 'OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}, {'id': 'OG002', 'title': 'OnabotulinumtoxinA Dose A', 'description': 'OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'spread': 'NA', 'comment': 'One incidence; therefore, SD not applicable', 'groupId': 'OG000'}, {'value': '120.0', 'spread': '46.4', 'groupId': 'OG001'}, {'value': '126.0', 'spread': '53.7', 'groupId': 'OG002'}]}]}], '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 (Normal Saline) Followed by OnabotulinumtoxinA Dose A', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.'}, {'id': 'FG001', 'title': 'OnabotulinumtoxinA Dose B', 'description': 'OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}, {'id': 'FG002', 'title': 'OnabotulinumtoxinA Dose A', 'description': 'OnabotulinumtoxinA Dose A 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': '156'}, {'groupId': 'FG001', 'numSubjects': '318'}, {'groupId': 'FG002', 'numSubjects': '313'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '271'}, {'groupId': 'FG002', 'numSubjects': '287'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Undisclosed alcohol abuse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Subjects were randomized to placebo, onabotulinumtoxinA Dose A, or onabotulinumtoxinA Dose B in Period 1. Subjects randomized to receive placebo or Dose B in Period 1, who subsequently continued to Period 2, received onabotulinumtoxinA Dose A in Period 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}, {'value': '787', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.'}, {'id': 'BG001', 'title': 'OnabotulinumtoxinA Dose B', 'description': 'OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}, {'id': 'BG002', 'title': 'OnabotulinumtoxinA Dose A', 'description': 'OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}, {'value': '749', 'groupId': 'BG003'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '278', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}, {'value': '702', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}], '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': 787}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'dispFirstSubmitDate': '2016-06-03', 'completionDateStruct': {'date': '2016-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-26', 'studyFirstSubmitDate': '2014-10-03', 'dispFirstSubmitQcDate': '2016-06-03', 'resultsFirstSubmitDate': '2017-06-26', 'studyFirstSubmitQcDate': '2014-10-07', 'dispFirstPostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-26', 'studyFirstPostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-03', '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': ['Facial Rhytides', 'Glabellar Rhytides']}, 'descriptionModule': {'briefSummary': "This is a safety and efficacy study of onabotulinumtoxinA in subjects with upper facial rhytides (forehead lines, glabellar lines, lateral canthal lines \\[crow's feet lines\\])."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Moderate to severe forehead lines, glabellar lines, and crow's feet 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 - 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': 'NCT02261493', 'briefTitle': 'A Safety and Efficacy Study of OnabotulinumtoxinA in Upper 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 Facial Rhytides (Forehead Lines, Glabellar Lines, Lateral Canthal Lines)', 'orgStudyIdInfo': {'id': '191622-143'}, 'secondaryIdInfos': [{'id': '2014-001815-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OnabotulinumtoxinA Dose A', 'description': 'OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.', 'interventionNames': ['Biological: OnabotulinumtoxinA']}, {'type': 'EXPERIMENTAL', 'label': 'OnabotulinumtoxinA Dose B', 'description': 'OnabotulinumtoxinA Dose B 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 Dose A', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A 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 Dose A', 'OnabotulinumtoxinA Dose B']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Placebo (normal saline) injected into the protocol-specified areas on Day 1.', 'armGroupLabels': ['Placebo followed by OnabotulinumtoxinA Dose A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'The Petrus Center for Aesthetic', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Westside Aesthetics', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Eye Research Foundation', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Steve Yoelin, MD Medical Associates, Inc.', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baumann Cosmetic & Research Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '63122', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10549', 'city': 'Mount Kisco', 'state': 'New York', 'country': 'United States', 'facility': 'The Center For Dermatology Cosmetic and Laser Surgery', 'geoPoint': {'lat': 41.20426, 'lon': -73.72708}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Clinical Research Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77056', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Center for Skin Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Premier Clinical Research', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'city': 'Aalst', 'country': 'Belgium', 'facility': 'Aalst Dermatology Clinic', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Jette', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'city': 'Limbourg', 'country': 'Belgium', 'facility': 'Medical Skin Care - Sint-Truiden', 'geoPoint': {'lat': 50.61222, 'lon': 5.9412}}, {'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Rosenpark Research', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'city': 'Köln Nordrhein-Westfalen', 'country': 'Germany', 'facility': 'Hautzentrum Koeln (Cologne Dermatology)'}, {'city': 'München', 'country': 'Germany', 'facility': 'Hautok und hautok-cosmetics', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'München', 'country': 'Germany', 'facility': 'Praxisgemeinschaft Theatiner46', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Starnberg', 'country': 'Germany', 'facility': 'Hautzentrum am Starnberger See GmbH', 'geoPoint': {'lat': 48.00193, 'lon': 11.34416}}, {'city': 'Wuppertal', 'country': 'Germany', 'facility': 'CentroDerm Study Center', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'zip': 'RG24 9DT', 'city': 'Basingstoke', 'country': 'United Kingdom', 'facility': 'Shakespeare House Health Centre, General Practice', 'geoPoint': {'lat': 51.26249, 'lon': -1.08708}}, {'zip': 'B74 2UG', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Medizen Clinic', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'PO18 8AN', 'city': 'Chichester', 'country': 'United Kingdom', 'facility': 'The Bosham Clinic', 'geoPoint': {'lat': 50.83673, 'lon': -0.78003}}, {'zip': 'ML5 3PA', 'city': 'Coatbridge', 'country': 'United Kingdom', 'facility': 'Waverlery Medical Practice', 'geoPoint': {'lat': 55.86216, 'lon': -4.02469}}, {'zip': 'CW9 8UW', 'city': 'Whitegate', 'country': 'United Kingdom', 'facility': 'The Gatehouse', 'geoPoint': {'lat': 53.21667, 'lon': -2.55}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}