Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-24 @ 7:58 PM
Study NCT ID:
NCT02721368
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2016-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuramis® Volume Lidocaine Treatment in Patients With Loss of Mid-face Volume
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-12', 'studyFirstSubmitDate': '2016-03-14', 'studyFirstSubmitQcDate': '2016-03-22', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)', 'timeFrame': '24 weeks', 'description': 'MFVDS 0- None, 1-Minimal, 2-Mild, 3-Moderate, 4-Significant, 5-Severe The lower score, the better condition.'}, {'measure': 'Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)', 'timeFrame': '104 weeks', 'description': 'Primary outcome for extension study'}], 'secondaryOutcomes': [{'measure': 'The changes in overall Mid-Face Volume Deficit Scale(MFVDS) at each visit', 'timeFrame': '104 weeks'}, {'measure': 'Ratio of subjects defined as improved by blinded investigators and the subjects according to the Global Aesthetic Improvement Scale (GAIS)', 'timeFrame': '104 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and efficacy of Neuramis® Volume Lidocaine, which is a biomaterial prosthesis and graft, with Juvederm® Voluma® with Lidocaine, for the patients who need correction due to a moderate-to-severe volume loss in the mid-facial region by inducing temporary volume restoration in mid-facial region. After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.', 'detailedDescription': 'This is a multi-centered, randomized, double-blind, split-face clinical study on investigational device. The subjects in this clinical trial receive application of the investigational device on the right and left side of the mid-facial region (Neuramis® Volume Lidocaine or Juvederm® Voluma® with Lidocaine). After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject aged between 35 and 65.\n2. Mid-facial region symmetrical, severity greater than MFVDS moderate-to-severe level\n\nExclusion Criteria:\n\n1. Those who have anticoagulant therapy, antiplatelet therapy, and non-steroidal anti-inflammatory drugs\n2. Those who have history of receiving the procedures which are considered to affect on the assessment of this clinical trial.\n3. Those who has thin skin in the mid-facial area\n4. Those with hypersensitivity to sodium hyaluronate or lidocaine or amide type local anesthetics\n\n\\<Extension Study\\>\n\nInclusion Criteria:\n\n1. Participated in the pivotal study and completed the end of study visit\n2. Agreed not to receive any procedure or treatment that may have an effect on the restoration of the mid-face volume while participating in the extension study\n\nExclusion Criteria\n\n1. Those who have following procedual history between completion of the pivotal study and entry of extension study\n\n \\- facial plastic surgery, tissue grafting or tissue augmentation using implant, thread lifting\n2. Subjects with asymmetric MVD(Mid-face volume deficit) or facial scar interfering with accurate assessment'}, 'identificationModule': {'nctId': 'NCT02721368', 'briefTitle': 'Neuramis® Volume Lidocaine Treatment in Patients With Loss of Mid-face Volume', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medy-Tox'}, 'officialTitle': 'Clinical Study of Neuramis® Volume Lidocaine to Evaluate the Efficacy and Safety for Temporary Restoring the Mid-face Volume', 'orgStudyIdInfo': {'id': 'MT_PRT_MVD01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational medical device', 'description': 'Neuramis® Volume Lidocaine', 'interventionNames': ['Device: Neuramis® Volume Lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator medical device', 'description': 'Juvederm® Voluma® with Lidocaine', 'interventionNames': ['Device: Juvederm® Voluma® with Lidocaine']}], 'interventions': [{'name': 'Neuramis® Volume Lidocaine', 'type': 'DEVICE', 'description': 'hyaluronic acid filler', 'armGroupLabels': ['Investigational medical device']}, {'name': 'Juvederm® Voluma® with Lidocaine', 'type': 'DEVICE', 'description': 'hyaluronic acid filler', 'armGroupLabels': ['Comparator medical device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-755', 'city': 'Seoul', 'state': 'Dongjak-gu', 'country': 'South Korea', 'facility': 'Chung-Ang Univ. Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'BeomJoon Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung-Ang Univ. Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medy-Tox', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}