Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT06216418
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2024-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds
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': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-19', 'studyFirstSubmitDate': '2024-01-11', 'studyFirstSubmitQcDate': '2024-01-19', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement rate (%) at 12 weeks after the procedure compared to baseline.', 'timeFrame': 'Baseline to week 12', 'description': 'Improvement rate (%) at 12 weeks after the procedure compared to baseline by an independent evaluator.'}], 'secondaryOutcomes': [{'measure': 'WSRS evaluation by an independent evaluator', 'timeFrame': 'Baseline to week 4, 8, 24', 'description': 'Improvement rate (%): 4, 8, and 24 weeks after treatment. Baseline score change (points): 4, 8, 12, and 24 weeks after the procedure.'}, {'measure': 'WSRS evaluation by tester', 'timeFrame': 'Baseline to week 4, 8, 24', 'description': 'Improvement rate (%): 4, 8, and 24 weeks after treatment. Baseline score change (points): 4, 8, 12, and 24 weeks after the procedure.'}, {'measure': 'Satisfaction level (%) at 4, 8, 12, and 24 weeks after the procedure compared to the baseline.', 'timeFrame': 'Baseline to week 4, 8, 12, 24', 'description': 'Satisfaction level (%) at 4, 8, 12, and 24 weeks after the procedure compared to the baseline by the subject'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasolabial Folds']}, 'descriptionModule': {'briefSummary': "Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds.", 'detailedDescription': "This clinical trial was conducted on patients who wanted to improve both nasolabial folds through facial tissue lifting using facial tissue fixing material 'BRFS-18G-S100WH' made of polydioxanone (PDO). Compared to 'MINT Lift FINE+', we want to confirm whether it has a non-inferior temporary wrinkle improvement effect and can be safely applied to the human body."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults over 19 years of age\n2. Those who wish to temporarily improve nasolabial folds on both sides of the face and have a score of 3 (Moderate) or 4 (Severe) on the WSRS (Wrinkle Severity Rating Scale)\n3. Those who voluntarily decided to participate in this clinical trial and agreed to the subject description and consent form in writing\n\nExclusion Criteria:\n\n1. A person who has undergone a procedure using filler or facial tissue fixation thread on the facial area.\n2. Those who are pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT06216418', 'briefTitle': "Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds", 'organization': {'class': 'INDUSTRY', 'fullName': 'Hugel'}, 'officialTitle': "A Single Center, Prospective, Comparative, Randomized, Double-blinded(Subject, Evaluator), Non-inferiority, Pivotal Clinical Study to Evaluate the Efficacy and Safety of the Polydioxanone Suture 'BRFS-18G-S100WH' Compared to 'MINT Lift FINE+' for Correction of the Nasolabial Folds", 'orgStudyIdInfo': {'id': 'JWD-TH-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BRFS-18G-S100WH', 'interventionNames': ['Device: BRFS-18G-S100WH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MINT Lift FINE+', 'interventionNames': ['Device: MINT Lift FINE+']}], 'interventions': [{'name': 'BRFS-18G-S100WH', 'type': 'DEVICE', 'description': 'A facial tissue fixation material made of polydioxanone (PDO).', 'armGroupLabels': ['BRFS-18G-S100WH']}, {'name': 'MINT Lift FINE+', 'type': 'DEVICE', 'description': 'A facial tissue fixation material made of polydioxanone (PDO).', 'armGroupLabels': ['MINT Lift FINE+']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'ChoLong Park', 'role': 'CONTACT'}], 'facility': 'Hugel Inc.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Cho Long Park', 'role': 'CONTACT', 'email': 'clpark@hugel.co.kr', 'phone': '+82-2-6966-1654'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hugel', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Jworld', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}