protocolSection identificationModule nctId: NCT06305520, orgStudyIdInfo id: BPLUS-NASAL-02, secondaryIdInfos id: CRIS NO. : KCT0008113, type: REGISTRY, domain: The Clinical Research Information Service (CRIS) in KOREA, briefTitle: Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds, acronym: BPLUS-02, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-03-10, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Bioplus, class: INDUSTRY, collaborators name: Seoul National University Hospital, collaborators name: Asan Medical Center, collaborators name: Soonchunhyang University Hospital, descriptionModule briefSummary: Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect, safety, and injection site pain when applied on nasolabial folds in adults.Design : 24-week efficacy and safety evaluation and additional 48-week long-term safety and efficacy evaluation with a multi-center, randomized, subject- \& evaluator-blind, matched pairs, active controlled, none-inferiority, confirmatory designTreatment Group: Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) Control Group: Application of the comparator device (RESTYLANE Lidocaine)Population: Number of subject 100\* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design)., conditionsModule conditions: Nasal Disease, conditions: Nasal Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Medical Device, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Investigational medical device (SkinPlus-HYAL Implant Lidocaine), interventions name: Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine), outcomesModule primaryOutcomes measure: Difference in the mean values of the Wrinkle Severity Rating Scale (WSRS) between the treatment and control groups as evaluated by an independent evaluator at 24 weeks after the application of the investigational medical device, secondaryOutcomes measure: Difference in the mean values of the WSRS between the treatment and control groups as evaluated by the investigator at 8, 16, 24, and 48 weeks after device application, secondaryOutcomes measure: Difference in the mean Global Aesthetic Improvement Scale (GAIS) values between the treatment and control groups as evaluated by the investigator at weeks 8, 16, 24, and 48 of the first post-device application phase compared to before application, secondaryOutcomes measure: Difference in the mean values of the WSRS between the treatment and control groups as evaluated by an independent evaluator at 48 weeks after device application., eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, city: Seoul, state: Jongnogu, zip: 03080, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False