Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-01-04 @ 2:31 AM
Study NCT ID:
NCT03738020
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2018-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of YVOIRE Classic Versus Restylane in Nasolabial Fold Intradermal Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sodam@lgchem.com', 'phone': '82-2-6987-4148', 'title': 'Study Leader', 'organization': 'LG Chem'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'HA IDF', 'description': 'Subject who were injected with investigational medical device at least once', 'otherNumAtRisk': 58, 'otherNumAffected': 3, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Restylane', 'description': 'Subject who were injected with investigational medical device at least once', 'otherNumAtRisk': 58, 'otherNumAffected': 3, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Systemic', 'description': 'Subject who were injected with investigational medical device at least once', 'otherNumAtRisk': 58, 'otherNumAffected': 5, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average of Wrinkle Severity Rating Scale (WSRS) Score Evaluated by the Evaluating Investigator at Week 26 (Visit 7) After the Final Treatment With the Investigational Medical Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HA IDF', 'description': 'HA IDF (YVOIRE classic): Treatment with HA IDF'}, {'id': 'OG001', 'title': 'Restylane', 'description': 'Restylane: Treatment with Restylane'}], 'classes': [{'categories': [{'measurements': [{'value': '2.56', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26 (Visit 7)', 'description': 'Wrinkle Severity Rating Scale (WSRS)\n\n1. Absent: no visible fold; continuous line\n2. Mild: Shallow but visible fold with slight indentation; minor facial feature\n3. Moderate: moderately deep fold; clear facial feature visible at normal appearance but not when stretched. Excellent correction expected.\n4. Severe: very long and deep; prominent facial feature; less than 2mm visible fold when stretched\n5. Extreme: extremely deep and long folds; 2-4mm visible v-shaped fold when stretched; detrimental to appearance; unlikely to have satisfactory correction with injectable implant alone', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Spilt-face design'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subjects', 'description': 'Subjects who enrolled in this study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'spilt-face design'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HA IDF and Restylane', 'description': 'Subjects who were included in efficacy evaluation'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.40', 'spread': '5.82', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'spilt-face design'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'IND approved from KFDA'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-28', 'studyFirstSubmitDate': '2018-11-09', 'resultsFirstSubmitDate': '2018-11-27', 'studyFirstSubmitQcDate': '2018-11-09', 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-28', 'studyFirstPostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average of Wrinkle Severity Rating Scale (WSRS) Score Evaluated by the Evaluating Investigator at Week 26 (Visit 7) After the Final Treatment With the Investigational Medical Device', 'timeFrame': 'Week 26 (Visit 7)', 'description': 'Wrinkle Severity Rating Scale (WSRS)\n\n1. Absent: no visible fold; continuous line\n2. Mild: Shallow but visible fold with slight indentation; minor facial feature\n3. Moderate: moderately deep fold; clear facial feature visible at normal appearance but not when stretched. Excellent correction expected.\n4. Severe: very long and deep; prominent facial feature; less than 2mm visible fold when stretched\n5. Extreme: extremely deep and long folds; 2-4mm visible v-shaped fold when stretched; detrimental to appearance; unlikely to have satisfactory correction with injectable implant alone'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Temporary Correction of Wrinkles']}, 'descriptionModule': {'briefSummary': 'This study was purposed to evaluate the non-inferiority of HA IDF, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold intradermal injection, compared to Restylane, the control preparation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: Women in 30\\~55 years.\n2. Those whose wrinkle scores in the treatment site (nasolabial fold) at the screening visit were Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically and who were informed on this study in detail, understood it completely, decided to participate in the study own their own and signed on the informed consent.\n\nExclusion Criteria:\n\n1. Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.) or those with a history of severe allergy.\n2. Patients with a disorder in autoimmune system\n3. Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly\n4. Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study.\n5. Those who had underwent a chemical peeling, laser procedure (including IPL) or insertion of other bioadaptive material within 3 months prior to the study (however, those who had been treated with HA filler could participate in the study if the date of treatment was known and the investigator judged that the filler effect had disappeared).\n6. Patients with a malignant tumor\n7. Women in pregnancy or lactation\n8. Hepatitis carriers or VDRL/HIV positive patients\n9. Those with a hypersensitivity to the investigational medical device of this study\n10. Other persons including those considered as difficult to perform this study by the principal investigator'}, 'identificationModule': {'nctId': 'NCT03738020', 'briefTitle': 'Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of YVOIRE Classic Versus Restylane in Nasolabial Fold Intradermal Injection', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Life Sciences'}, 'officialTitle': 'A Randomized, Multi Center, Single-blind, Active-controlled, Matched Pairs Design Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of HA IDF Versus Restylane in Nasolabial Fold Intradermal Injection', 'orgStudyIdInfo': {'id': 'LG-HACL008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HA IDF', 'interventionNames': ['Device: HA IDF (YVOIRE classic)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restylane', 'interventionNames': ['Device: Restylane']}], 'interventions': [{'name': 'HA IDF (YVOIRE classic)', 'type': 'DEVICE', 'description': 'Treatment with HA IDF', 'armGroupLabels': ['HA IDF']}, {'name': 'Restylane', 'type': 'DEVICE', 'description': 'Treatment with Restylane', 'armGroupLabels': ['Restylane']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}