Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 5:50 AM
Study NCT ID:
NCT07412392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Nasolabial Fold Severity Score at Week 24', 'timeFrame': 'Baseline to Week 24'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Nasolabial Fold Severity Score at Week 48', 'timeFrame': 'Baseline to Week 48'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasolabial Folds, Wrinkles']}, 'descriptionModule': {'briefSummary': 'Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 19 to 75 years\n* Voluntarily provided written informed consent\n* Moderate to severe symmetrical nasolabial folds (WSRS score 3 or 4 on both sides)\n* Agree to discontinue other facial dermatologic treatments (e.g., fillers, botulinum toxin, laser) during the study\n* Able to understand instructions and comply with study procedures\n\nExclusion Criteria:\n\n* Active facial skin disease, infection, or untreated scars in the treatment area\n* History of severe allergy or hypersensitivity to device components\n* Facial aesthetic or invasive procedures in the treatment area within 6 months prior to screening\n* Use of prohibited medications within required washout periods\n* Participation in another interventional clinical trial within 4 weeks prior to screening or during the study\n* Pregnancy, breastfeeding, or non-compliance with contraception requirements\n* Any condition deemed inappropriate by the investigator'}, 'identificationModule': {'nctId': 'NCT07412392', 'briefTitle': 'Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hyundae Meditech'}, 'officialTitle': 'A Multi Center, Randomized, Subject & Independent Evaluator-blinded, Matched Pairs, Active Controlled, Non-inferiority, Pivotal Study to Evaluate the Efficacy and Safety of Injection With DIOSHA S Lido as Compared to YOUTHFILL(YOUTHFILL Fine With Lidocaine) in Temporary Correction of Moderate to Severe Nasolabial Folds', 'orgStudyIdInfo': {'id': 'HD-CIP-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DIOSHA S Lido Injection', 'interventionNames': ['Device: DIOSHA S Lido']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'YOUTHFILL Fine with Lidocaine Injection', 'interventionNames': ['Device: YOUTHFILL Fine with Lidocaine']}], 'interventions': [{'name': 'DIOSHA S Lido', 'type': 'DEVICE', 'description': 'Injection of a hyaluronic acid dermal filler containing lidocaine into the nasolabial folds for the temporary correction of moderate to severe nasolabial folds. Treatment is administered according to the study protocol, and participants are followed through Week 48 for efficacy and safety assessments.', 'armGroupLabels': ['DIOSHA S Lido Injection']}, {'name': 'YOUTHFILL Fine with Lidocaine', 'type': 'DEVICE', 'description': 'Injection of a hyaluronic acid dermal filler containing lidocaine into the nasolabial folds for the temporary correction of moderate to severe nasolabial folds. Treatment is administered according to the study protocol, and participants are followed through Week 48 for efficacy and safety assessments.', 'armGroupLabels': ['YOUTHFILL Fine with Lidocaine Injection']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hyundae Meditech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}