Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-23 @ 8:50 AM
Study NCT ID:
NCT02119793
Status:
COMPLETED
Last Update Posted:
2018-11-09
First Post:
2014-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extension Clinical Study to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of YVOIRE Contour Injected Into the Anteromedial Malar Region in Subjects Who Have Completed the LG-HACL014 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-07', 'studyFirstSubmitDate': '2014-04-17', 'studyFirstSubmitQcDate': '2014-04-17', 'lastUpdatePostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mid Face Aesthetic Scale (MFAS) score', 'timeFrame': '2, 26, and 52 weeks after repeat treatment', 'description': 'Mean of MFAS score as assessed by the independent blinded rater'}], 'secondaryOutcomes': [{'measure': 'Mid Face Aesthetic Scale (MFAS) score', 'timeFrame': '2, 26, and 52 weeks after repeat treatment', 'description': 'Changes of MFAS score as assessed by the independent blinded rater'}, {'measure': 'Mid Face Aesthetic Scale (MFAS) Responder rate', 'timeFrame': '2, 26, and 52 weeks after repeat treatment', 'description': 'MFAS Responder (at least a one-point improvement on the MFAS) rate as assessed by the independent blinded rater'}, {'measure': 'Global Aesthetic Improvement Scale (GAIS) score', 'timeFrame': '2, 26, and 52 weeks after repeat treatment', 'description': 'Mean of GAIS score as assessed by subject'}, {'measure': 'Global Aesthetic Improvement Scale (GAIS) Responder rate', 'timeFrame': '2, 26, and 52 weeks after repeat treatment', 'description': 'GAIS Responder (at least a one-point improvement on the GAIS) rate as assessed by subject'}]}, 'conditionsModule': {'conditions': ['Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region Who Have Completed the LG-HACL014 Study']}, 'descriptionModule': {'briefSummary': 'This study is purposed to evaluate the long-term efficacy and safety of repeat treatment of YVOIRE contour injected into the anteromedial malar region in subjects who have completed the LG-HACL014 study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible subjects who have completed the LG-HACL014 study\n* Have anteromedial malar region volume loss at least a one-point worse on the MFAS compared with 2 weeks after treatment in the LG-HACL014 study\n* Accept the obligation not to receive any other mid facial procedures or treatments during the study\n* Signed informed consent\n* Those who fall under one of the following 3 cases\n\n 1. Males or females who are surgically sterile\n 2. Post-Menopausal females who are above 45 years of age and 2 years after the last menstruation\n 3. Fertile premenopausal females or males without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the repeat treatment of the investigational device to avoid pregnancy\n\nExclusion Criteria:\n\n* Have a history of hypertrophic scars or keloids\n* Other criteria as identified in the protocol'}, 'identificationModule': {'nctId': 'NCT02119793', 'briefTitle': 'Extension Clinical Study to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of YVOIRE Contour Injected Into the Anteromedial Malar Region in Subjects Who Have Completed the LG-HACL014 Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Life Sciences'}, 'officialTitle': 'A Multicenter, Extension Clinical Study to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of YVOIRE Contour Injected Into the Anteromedial Malar Region in Subjects Who Have Completed the LG-HACL014 Study', 'orgStudyIdInfo': {'id': 'LG-HACL015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YVOIRE contour', 'interventionNames': ['Device: YVOIRE contour']}], 'interventions': [{'name': 'YVOIRE contour', 'type': 'DEVICE', 'description': 'YVOIRE contour injection into the anteromedial malar region', 'armGroupLabels': ['YVOIRE contour']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}