Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-26 @ 2:18 AM
Study NCT ID:
NCT05777759
Status:
COMPLETED
Last Update Posted:
2025-01-17
First Post:
2023-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'dispFirstSubmitDate': '2024-04-30', 'completionDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2023-03-09', 'dispFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Effectiveness Objective', 'timeFrame': '3 months after last treatment', 'description': "Change from Baseline in the Blinded Evaluators' live assessment using the GCRS (Galderma Chin Retrusion Scale)."}], 'secondaryOutcomes': [{'measure': 'Secondary Effectiveness Objective', 'timeFrame': '6, 9, and 12 months after last treatment.', 'description': "Responder rate based on the Blinded Evaluator's live assessment using the GCRS (Galderma Chin Retrusion Scale) at 6, 9, and 12 months after last treatment."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chin Augmentation', 'Chin Retrusion']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to demonstrate non-inferiority of Restylane Lyft with Lidocaine versus a comparator-control for augmentation of the chin region to improve the chin profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or non-pregnant, non-breastfeeding females, 22 years of age or older\n* Intent to receive treatment for augmentation and correction of retrusion in the chin region.\n\nExclusion Criteria:\n\n* Known/previous allergy of hypersensitivity to any injectable hyaluronic acid (HA) gel or gram-positive bacterial proteins.\n* Known/previous allergy or hypersensitivity to local anesthetics, e.g., lidocaine or other amide-type anesthetics.\n* Previous or present multiple severe allergies or severe allergies, such as manifested by anaphylaxis or angioedema or family history of angioedema.\n* Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from the subnasale.\n* Any previous aesthetic procedures or implants\n* Presence of any disease or lesion near or on the area to be treated.'}, 'identificationModule': {'nctId': 'NCT05777759', 'briefTitle': 'Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile', 'orgStudyIdInfo': {'id': '43USCH2208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'New Dermal Filler for indication: Restylane Lyft with Lidocaine', 'description': 'hyaluronic acid dermal filler', 'interventionNames': ['Device: Restylane Lyft with Lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: FDA approved Dermal Filler: Juvederm Voluma XC', 'description': 'hyaluronic acid dermal filler', 'interventionNames': ['Device: Juvederm Voluma XC']}], 'interventions': [{'name': 'Restylane Lyft with Lidocaine', 'type': 'DEVICE', 'description': 'hyaluronic acid', 'armGroupLabels': ['New Dermal Filler for indication: Restylane Lyft with Lidocaine']}, {'name': 'Juvederm Voluma XC', 'type': 'DEVICE', 'description': 'hyaluronic acid', 'armGroupLabels': ['Active Comparator: FDA approved Dermal Filler: Juvederm Voluma XC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90266', 'city': 'Manhattan Beach', 'state': 'California', 'country': 'United States', 'facility': 'United States, California', 'geoPoint': {'lat': 33.88474, 'lon': -118.41091}}, {'zip': '06880', 'city': 'Westport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 41.14149, 'lon': -73.3579}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33143', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '30022', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '02467', 'city': 'Chestnut Hill', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 42.33065, 'lon': -71.16616}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78660', 'city': 'Pflugerville', 'state': 'Texas', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 30.43937, 'lon': -97.62}}, {'zip': '00917', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galderma R&D'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}