Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-09 @ 12:35 PM
Study NCT ID:
NCT06574750
Status:
COMPLETED
Last Update Posted:
2024-08-28
First Post:
2024-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a New HA Filler in Correcting Nasolabial Fold
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D036881', 'term': 'Long-Term Synaptic Depression'}], 'ancestors': [{'id': 'D009473', 'term': 'Neuronal Plasticity'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2024-08-22', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WSRS', 'timeFrame': 'at 24 weeks after treatment', 'description': 'Wrinkle Severity Rating Scale from 1 (no visible fold) to 5 (extremely deep and long folds)'}], 'secondaryOutcomes': [{'measure': 'GAIS', 'timeFrame': 'at 24 weeks after treatment', 'description': 'Global Aesthetic Improvement Scale from 3 (very much improved) to -1 (worse).'}, {'measure': 'Adverse events related to the procedure', 'timeFrame': 'up to 24 weeks', 'description': 'Patients were required to report any adverse events up to 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging Problems']}, 'descriptionModule': {'briefSummary': 'The investigators aimed to evaluate the efficacy and safety of new HA filler for nasolabial fold correction', 'detailedDescription': 'A 24-week prospective, single-center, assessor-blinded, randomized, split-face study was conducted to compare the clinical efficacy and safety of new HA filler versus Juvederm for nasolabial fold correction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had prominent NLFs with a WSRS score of 3 or 4 on both sides\n\nExclusion Criteria:\n\n* patients with active facial skin diseases or history of severe allergies, autoimmune disorders, or hypersensitivity to HA or any of the excipients contained in the investigational filler\n* participants who had used a local topical preparation (steroid and retinoid) within 2 weeks before the study\n* participants who had undergone chemical peeling, laser procedures, or acne treatments within 4 months before the study\n* participants who had been injected with other biomaterials, including HA within 6 months before the study.'}, 'identificationModule': {'nctId': 'NCT06574750', 'briefTitle': 'Effect of a New HA Filler in Correcting Nasolabial Fold', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'New HA Filler Versus Juvederm for Nasolabial Fold Correction', 'orgStudyIdInfo': {'id': 'E-2105/684-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'New HA filler (Curea)', 'description': 'The left/right assignment was sealed in a nontransparent envelop.', 'interventionNames': ['Drug: CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Juvederm', 'description': 'The left/right assignment was sealed in a nontransparent envelop.', 'interventionNames': ['Drug: JuvedermⓇ (Q-Med AB, Uppsala, Sweden)']}], 'interventions': [{'name': 'CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea)', 'type': 'DRUG', 'otherNames': ['experimental group'], 'description': 'Hyaluronic acid filler injection were administered into the mid-dermis of the nasolabial fold.', 'armGroupLabels': ['New HA filler (Curea)']}, {'name': 'JuvedermⓇ (Q-Med AB, Uppsala, Sweden)', 'type': 'DRUG', 'otherNames': ['active control group'], 'description': 'Hyaluronic acid filler injection were administered into the mid-dermis of the nasolabial fold.', 'armGroupLabels': ['Juvederm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}], 'overallOfficials': [{'name': 'Bo Ri Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Bo Ri Kim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}