Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2026-01-01 @ 9:53 AM
Study NCT ID:
NCT05106751
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2021-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2021-10-24', 'studyFirstSubmitQcDate': '2021-10-24', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change on the Nasolabial Fold Rating Scale (NLFRS) from baseline to Week24.', 'timeFrame': '24 weeks from baseline', 'description': 'To evaluate the performance of YVOIRE Classic plus on Nasolabial Fold 24 weeks after treatment, the mean change from baseline to 24 weeks will be measured using 5-point Nasolabial Fold Rating Scale (NLFRS). NLFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Extreme).'}, {'measure': 'Responder rate calculated using Nasolabial Fold Rating Scale (NLFRS) for Nasolabial fold at Week 24.', 'timeFrame': '24 weeks from baseline', 'description': 'To evaluate the performance of YVOIRE Classic plus on Nasolabial fold 24 weeks after treatment, the responder rate defined as ≥ 1-point improvement on the 5-point Nasolabial Fold Rating Scale (NLFRS) from baseline to 24 weeks will be calculated.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Correction of Nasolabial Folds']}, 'descriptionModule': {'briefSummary': 'A Study to Evaluate the Performance and Safety of YVOIRE Classic plus on NLF.', 'detailedDescription': 'This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Classic plus Versus Comparator for Temporary Correction of Nasolabial Folds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 21 years or above age.\n* 2 or 3 of the 5-point (0-4) NLFRS (Nasolabial Fold Rating Scale).\n* Agree to use proper contraception as guided in the protocol.\n* Signed for Informed Consent.\n\nExclusion Criteria:\n\n* have received permanent facial implants anywhere in the face or neck or planning during the investigation.\n* have undergone facial plastic surgery of the lower face and nasolabial region within 12 weeks\n* have undergone semi-permanent filler in lower face\n* have undergone temporary dermal filler treatment in the lower two-thirds of face within 12 months\n* Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower two-thirds of face\n* Have undergone mesotherapy or cosmetic procedures in face or neck within 6 months\n* have used any over-the-counter anti-wrinkle products or prescription anti-wrinkle medicines for the nasolabial folds within 28 days'}, 'identificationModule': {'nctId': 'NCT05106751', 'briefTitle': 'A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Chem'}, 'officialTitle': 'A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds', 'orgStudyIdInfo': {'id': 'LG-HACL033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YVOIRE Classic plus', 'interventionNames': ['Device: Hyaluronic acid dermal filler']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restylane Lidocaine', 'interventionNames': ['Device: Hyaluronic acid dermal filler']}], 'interventions': [{'name': 'Hyaluronic acid dermal filler', 'type': 'DEVICE', 'description': 'Hyaluronic acid dermal filler used for facial volume or wrinkle correction', 'armGroupLabels': ['Restylane Lidocaine', 'YVOIRE Classic plus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Darmstadt', 'country': 'Germany', 'facility': 'LG Chem investigational site 01', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Chem', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}