Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-31 @ 10:33 PM
Study NCT ID:
NCT05622812
Status:
COMPLETED
Last Update Posted:
2025-03-07
First Post:
2022-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reception.seupp@galderma.com', 'phone': '1-817-961-5000', 'title': 'Head of Development', 'organization': 'Q-Med AB'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline up to 12 months after last treatment', 'description': 'The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.', 'eventGroups': [{'id': 'EG000', 'title': 'Restylane Lyft Lidocaine', 'description': 'Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 39, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'No-treatment Control Group', 'description': 'Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 12, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Face injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Attention deficit hyperactivity disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urogenital prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Actinic cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Postmenopause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Responders Having At Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on Galderma Jawline Scale (GJS) at Month 3 as Assessed by Blinded Evaluator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Restylane Lyft Lidocaine', 'description': 'Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.'}, {'id': 'OG001', 'title': 'No-treatment Control Group', 'description': 'Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000', 'lowerLimit': '57.8', 'upperLimit': '76.4'}, {'value': '28.6', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': '46.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.0', 'ciLowerLimit': '21.6', 'ciUpperLimit': '56.5', 'pValueComment': "Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \\<0.05.", 'estimateComment': 'Difference confidence interval calculated using normal approximation.', 'statisticalMethod': "Fisher's Exact Test.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3', 'description': "The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently.", 'unitOfMeasure': 'percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT population. The ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders Having at Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on GJS at Month 6, 9 and 12 as Assessed by Blinded Evaluator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Restylane Lyft Lidocaine', 'description': 'Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.'}, {'id': 'OG001', 'title': 'No-treatment Control Group', 'description': 'Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000', 'lowerLimit': '51.9', 'upperLimit': '71.8'}, {'value': '21.9', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '40.0'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000', 'lowerLimit': '47.7', 'upperLimit': '67.6'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '33.7'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.5', 'groupId': 'OG000', 'lowerLimit': '39.4', 'upperLimit': '59.6'}, {'value': '19.4', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '37.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.4', 'ciLowerLimit': '23.1', 'ciUpperLimit': '57.6', 'pValueComment': "Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \\<0.05.", 'estimateComment': 'Difference confidence interval calculated using normal approximation.', 'groupDescription': 'Month 6', 'statisticalMethod': "Fisher's Exact Test.", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.7', 'ciLowerLimit': '25.6', 'ciUpperLimit': '57.8', 'pValueComment': "Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \\<0.05.", 'estimateComment': 'Difference confidence interval calculated using normal approximation.', 'groupDescription': 'Month 9', 'statisticalMethod': "Fisher's Exact Test.", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.2', 'ciLowerLimit': '13.2', 'ciUpperLimit': '47.1', 'pValueComment': "Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \\<0.05.", 'estimateComment': 'Difference confidence interval calculated using normal approximation.', 'groupDescription': 'Month 12', 'statisticalMethod': "Fisher's Exact Test.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Months 6, 9 and 12', 'description': 'The GJS is a validated 5-point scale for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. Here, higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently.', 'unitOfMeasure': 'percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on ITT population. The ITT population included all participants who were randomized. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Having at Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) on Both Jawlines Concurrently, as Assessed Live by the Treating Investigator at Months 3, 6, 9 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Restylane Lyft Lidocaine', 'description': 'Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.'}, {'id': 'OG001', 'title': 'No-treatment Control Group', 'description': 'Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000', 'lowerLimit': '94.7', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.6'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000', 'lowerLimit': '91.4', 'upperLimit': '99.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '25.0'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000', 'lowerLimit': '82.7', 'upperLimit': '95.2'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '25.8'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.4', 'groupId': 'OG000', 'lowerLimit': '71.4', 'upperLimit': '87.6'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '22.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.0', 'ciLowerLimit': '97.1', 'ciUpperLimit': '100.0', 'pValueComment': "Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \\<0.05.", 'estimateComment': 'Difference confidence interval calculated using normal approximation.', 'groupDescription': 'Month 3', 'statisticalMethod': "Fisher's Exact Test.", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '87.6', 'ciLowerLimit': '76.9', 'ciUpperLimit': '98.2', 'pValueComment': "Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \\<0.05.", 'estimateComment': 'Difference confidence interval calculated using normal approximation.', 'groupDescription': 'Month 6', 'statisticalMethod': "Fisher's Exact Test.", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '80.5', 'ciLowerLimit': '68.6', 'ciUpperLimit': '92.4', 'pValueComment': "Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \\<0.05.", 'estimateComment': 'Difference confidence interval calculated using normal approximation.', 'groupDescription': 'Month 9', 'statisticalMethod': "Fisher's Exact Test.", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '73.7', 'ciLowerLimit': '61.9', 'ciUpperLimit': '85.5', 'pValueComment': "Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \\<0.05.", 'estimateComment': 'Difference confidence interval calculated using normal approximation.', 'groupDescription': 'Month 12', 'statisticalMethod': "Fisher's Exact Test.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Months 3, 6, 9 and 12', 'description': 'The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the Treating Investigator was reported here.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on the ITT population. The ITT population included all randomized participants. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Having at Least "Improved" on the GAIS on Both Jawlines Concurrently, as Assessed Live by the Participant at Months 3, 6, 9 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Restylane Lyft Lidocaine', 'description': 'Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.'}, {'id': 'OG001', 'title': 'No-treatment Control Group', 'description': 'Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.1', 'groupId': 'OG000', 'lowerLimit': '86.4', 'upperLimit': '97.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.6'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.9', 'groupId': 'OG000', 'lowerLimit': '79.8', 'upperLimit': '93.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.4', 'groupId': 'OG000', 'lowerLimit': '71.4', 'upperLimit': '87.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '11.2'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.6', 'groupId': 'OG000', 'lowerLimit': '61.8', 'upperLimit': '80.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '11.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '93.1', 'ciLowerLimit': '88.2', 'ciUpperLimit': '98.0', 'pValueComment': "Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \\<0.05.", 'estimateComment': 'Difference confidence interval calculated using normal approximation.', 'groupDescription': 'Month 3', 'statisticalMethod': "Fisher's Exact Test.", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '87.9', 'ciLowerLimit': '81.4', 'ciUpperLimit': '94.3', 'pValueComment': "Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \\<0.05.", 'estimateComment': 'Difference confidence interval calculated using normal approximation.', 'groupDescription': 'Month 6', 'statisticalMethod': "Fisher's Exact Test.", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '80.4', 'ciLowerLimit': '72.7', 'ciUpperLimit': '88.1', 'pValueComment': "Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \\<0.05.", 'estimateComment': 'Difference confidence interval calculated using normal approximation.', 'statisticalMethod': "Fisher's Exact Test.", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.6', 'ciLowerLimit': '62.8', 'ciUpperLimit': '80.3', 'pValueComment': "Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \\<0.05.", 'estimateComment': 'Difference confidence interval calculated using normal approximation.', 'groupDescription': 'Month 12', 'statisticalMethod': "Fisher's Exact Test.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Months 3, 6, 9 and 12', 'description': 'The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the participant was reported here.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on the ITT population. The ITT population included all randomized participants. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Restylane Lyft Lidocaine', 'description': 'Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.'}, {'id': 'FG001', 'title': 'No-treatment Control Group', 'description': 'Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 9 sites in Canada from 16 February 2023 to 14 June 2024.', 'preAssignmentDetails': 'A total of 150 participants were screened, of which 10 were screen failures. A total of 140 participants were enrolled and randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Restylane Lyft Lidocaine', 'description': 'Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.'}, {'id': 'BG001', 'title': 'No-treatment Control Group', 'description': 'Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '10.82', 'groupId': 'BG000'}, {'value': '53.2', 'spread': '11.13', 'groupId': 'BG001'}, {'value': '54.7', 'spread': '10.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on the intent-to-treat (ITT) population. The ITT population included all participants who were randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-21', 'size': 3543621, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-20T02:01', 'hasProtocol': True}, {'date': '2023-10-19', 'size': 3177889, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-20T02:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigator blinding will be accomplished by having a Treating Investigator administer the treatments and having a Blinded Evaluator, to whom randomization and treatment are concealed, conduct blinded assessments.\n\nInvestigator blinding will be accomplished by having a Treating Investigator administer the treatments and having a Blinded Evaluator, to whom randomization and treatment are concealed, conduct blinded assessments. Safety assessments will be performed by non-blinded personnel.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective, randomized, evaluator-blinded, no treatment controlled, parallel group, multicenter phase IV study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for jawline definition.\n\nA parallel study: two or more groups of participants receive different interventions. Trial participants are assigned to one of the treatment arms at the beginning of the trial and remain in that trial arm throughout the length of the trial. A randomized group is usually assigned.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2022-11-07', 'resultsFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2022-11-11', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-04', 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Responders Having At Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on Galderma Jawline Scale (GJS) at Month 3 as Assessed by Blinded Evaluator', 'timeFrame': 'Baseline, Month 3', 'description': "The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently."}], 'secondaryOutcomes': [{'measure': 'Percentage of Responders Having at Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on GJS at Month 6, 9 and 12 as Assessed by Blinded Evaluator', 'timeFrame': 'Baseline, Months 6, 9 and 12', 'description': 'The GJS is a validated 5-point scale for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. Here, higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently.'}, {'measure': 'Percentage of Participants Having at Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) on Both Jawlines Concurrently, as Assessed Live by the Treating Investigator at Months 3, 6, 9 and 12', 'timeFrame': 'Baseline, Months 3, 6, 9 and 12', 'description': 'The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the Treating Investigator was reported here.'}, {'measure': 'Percentage of Participants Having at Least "Improved" on the GAIS on Both Jawlines Concurrently, as Assessed Live by the Participant at Months 3, 6, 9 and 12', 'timeFrame': 'Baseline, Months 3, 6, 9 and 12', 'description': 'The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the participant was reported here.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Jawline Definition']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition', 'detailedDescription': 'A randomized, evaluator-blinded, parallel group, no treatment controlled, multicenter study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition in Canada'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female adults willing to comply with the requirements of the study and providing a signed written informed consent\n* Consent the use of facial images for marketing purposes and educational material\n* Subject with moderate to very severe (Grade 2 to 4) on the GJS\n* Subject is willing to abstain from any other facial, submental, and/or neck aesthetic procedure(s) or implant\n* Female of childbearing potential with a negative urine pregnancy test before treatment\n\nExclusion Criteria:\n\n* Subjects presenting with known/previous allergy or hypersensitivity to hyaluronic acid (HA) filler, lidocaine or other amide-type local anesthetics\n* Subjects presenting with known/previous allergy or hypersensitivity to streptococcal proteins\n* Subject with bleeding disorders or taking thrombolytics or anticoagulants\n* Prior surgical procedure in the treatment area\n* History of other facial treatment/procedure in the previous 6 months HA in or near the intended treatment site\n* Presence of any disease or lesions near or on the area to be treated\n* Presence of any condition, in the opinion of the Treating Investigator, makes the subject unable to complete the study per protocol\n* Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period\n* Study site personnel, close relatives of the study site personnel, employees, or close relatives of employees at the Sponsor Company\n* Participation in any other interventional clinical study within 30 days before treatment'}, 'identificationModule': {'nctId': 'NCT05622812', 'briefTitle': 'Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multicenter Study to Evaluate Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition', 'orgStudyIdInfo': {'id': '05DF2209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Initial Restylane Lyft Lidocaine injection and one optional touch-up treatment at 1 month after treatment', 'interventionNames': ['Device: Restylane Lyft Lidocaine']}, {'type': 'NO_INTERVENTION', 'label': 'No-treatment control group', 'description': 'Optional treatment will be administered at 12 months'}], 'interventions': [{'name': 'Restylane Lyft Lidocaine', 'type': 'DEVICE', 'description': 'Treatment for Jawline definition', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z4E1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6H4E1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L7N3N2', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Galderma 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