Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-22 @ 9:36 AM
Study NCT ID:
NCT02334358
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2015-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Classic s
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': {'timeFrame': 'Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.', 'eventGroups': [{'id': 'EG000', 'title': 'YVOIRE Classic s', 'description': 'Treatment with YVOIRE Classic s\n\nYVOIRE Classic s', 'otherNumAtRisk': 503, 'deathsNumAtRisk': 503, 'otherNumAffected': 55, 'seriousNumAtRisk': 503, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numAffected': 55}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Extremity injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Endometrial lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cervical intraepithelial neoplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Polyps of duodenum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Device-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'YVOIRE Classic s', 'description': 'Treatment with YVOIRE Classic s\n\nYVOIRE Classic s'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'YVOIRE Classic s', 'description': 'YVOIRE Classic s'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '503'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '494'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'YVOIRE Classic s', 'description': 'Treatment with YVOIRE Classic s\n\nYVOIRE Classic s'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.44', 'spread': '9.85', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '480', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '494', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 503}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-09', 'studyFirstSubmitDate': '2015-01-04', 'resultsFirstSubmitDate': '2018-11-09', 'studyFirstSubmitQcDate': '2015-01-06', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-09', 'studyFirstPostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Device-related Adverse Events', 'timeFrame': 'Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Correction of Nasolabial Folds']}, 'descriptionModule': {'briefSummary': 'To evaluate long-term safety of YVOIRE classic s by incidence of adverse events including injection site local reactions and biodegradability'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subject who receive hyaluronic acid filler into the nasolabial folds', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects whose age is over 18 years old\n2. Subjects whose WSRS grade is equal or greater than 2\n3. Subjects must be willing and able to provide written informed consent\n4. Subjects who are scheduled to be treated with YVOIRE classic s for facial tissue augmentation to correct the nasolabial folds\n\nExclusion Criteria:\n\n1. Subjects who are sensitive to hyaluronic acid or any excipients of YVOIRE classic s\n2. Subjects who have received permanent implantation (silicone, PAAG, PMMA, CaHA etc) on the nasolabial folds\n3. Subjects who have received nonpermanent aesthetic treatments, such as botulinum toxin injection or filler on the nasolabial folds within 9 months before screening\n4. Subjects who have received face lifting or plastic surgery on face within 9 months before screening\n5. Subjects who have received laser therapy on the nasolabial folds, chemical peeling or peeling on face within 3 months before the screening\n6. Subjects who have any skin diseases (including inflammation and skin cancer) or infectious diseases on the injection sites\n7. Subjects who tend to have hypertrophic scars\n8. Subjects with a history of streptococcal disease, severe allergy or anaphylaxis or bleeding disorders.\n9. Women in pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT02334358', 'briefTitle': 'Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Classic s', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Life Sciences'}, 'officialTitle': 'A Multi-center, Prospective and Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Classic s Injected Into the Nasolabial Folds', 'orgStudyIdInfo': {'id': 'LG-HAOS004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'YVOIRE Classic s', 'description': 'Treatment with YVOIRE Classic s', 'interventionNames': ['Device: YVOIRE Classic s']}], 'interventions': [{'name': 'YVOIRE Classic s', 'type': 'DEVICE', 'armGroupLabels': ['YVOIRE Classic s']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai Ninth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Q Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}