Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-07 @ 9:30 PM
Study NCT ID:
NCT06471933
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-26
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 59}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2024-06-23', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade.', 'timeFrame': '12 months after final injection', 'description': 'Average improvement of at least 1 grade on the WSRS of the combined left and right NLF score.\n\nScore 1-5, Higher scores are a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects with improvement of at least 1 grade on the WSRS.', 'timeFrame': 'Up to 24 months after final injection', 'description': 'Percentage of subjects with an improvement of at least 1 grade on the WSRS of the left and right (mean of the two) NLF at 3, 6 and 24 months after final injection compared to baseline (investigator assessment at all visits, blinded assessment at 12 months).'}, {'measure': 'Change in WSRS score', 'timeFrame': 'Up to 24 months after final injection', 'description': 'Change in WSRS score of the NLF at 3, 6, 12 and 24 months after final injection compared to baseline.\n\nScore 1-5, Higher scores are a worse outcome.'}, {'measure': 'Mean WSRS of <2 at each follow-up time', 'timeFrame': 'Up to 24 months after final injection', 'description': 'Proportion of subjects with a mean WSRS of \\<2 at each follow-up time point at 3, 6, 12, and 24 months after final injection.'}, {'measure': 'Time to at least one grade improvement in mean WSRS and time to mean WSRS <2.', 'timeFrame': 'Up to 24 months after final injection', 'description': 'Time to at least one grade improvement in mean WSRS and time to mean WSRS \\<2.'}, {'measure': 'Change Face-Q score of Nasolabial Fold', 'timeFrame': 'Up to 24 months after final injection', 'description': 'Change in FACE-Q score of the NLF at 6, 12, and 24 months after final injection compared to baseline.\n\nScores 1-4: high scores better outcome'}, {'measure': 'Change in Global Aesthetic in Improvement Scale', 'timeFrame': 'Up to 24 months after final injection', 'description': 'Change in Global Aesthetic Improvement Scale (GAIS) scores evaluated by the subject, the investigator and a blinded assessor from 2D facial digital imaging at 6, 12, and 24 months after final injection compared to baseline.\n\nScale 1-5; High scores worse outcome'}, {'measure': 'Subject Satisfaction Scores', 'timeFrame': 'Up to 24 months after final injection', 'description': 'Assessment of Subject Satisfaction Scores at 6, 12, and 24 months after final injection.\n\nScale 1-5; High scores better outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasolabial Fold']}, 'descriptionModule': {'briefSummary': 'The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine.\n\nThe main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds.\n\nParticipants will:\n\nReceive 3 rounds of treatment and will be followed up for a total of 2 years.', 'detailedDescription': 'The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine.\n\nThe main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds.\n\nParticipants will:\n\nReceive 3 rounds of treatment and will be followed up for a total of 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed Consent Form\n* Male or female, ≥18 years old.\n* Immune-competent individuals.\n* Presenting NLF contour deficiencies with a WSRS score between 2 (shallow wrinkle) and 4 (deep wrinkle) on both the left and right side of the face.\n\nExclusion Criteria:\n\n* Having received a prior facial surgery for NLF correction, and/or received any local therapeutic treatment (e.g., dermal fillers).\n* Having received in the past 2 weeks any local therapeutic treatment of the face below zygomatic arch.\n* Pigmentation in NLF or having a history of hypo melanosis.\n* Susceptibility to keloid formation or hypertrophic scarring.\n* History of a known allergic reaction (e.g., any subject allergic to lidocaine or amide anesthetics, has a history of allergy to Gram-positive bacterial protein, or known to be allergic to any of the constituents of the product: PLLA, sodium carboxymethyl cellulose, mannitol, or sodium hyaluronate).\n* History of herpes eruption, or a history of malignant skin disorder, or a history of any other serious disease.\n* Hemorrhagic disease or receiving anti-coagulant therapy.\n* Presenting with acute inflammation, infection, or having a history of chronic or recurrent infection potentially affecting the safety or performance of the device or increasing risk for adverse events.\n* Having received in the past 2 months immunosuppressant or systemic steroid therapy.\n* Having any disease that may affect wound healing, such as connective tissue disorder or serious malnutrition.\n* Female who is pregnant and/or lactating\n* Any other condition that as judged by the investigator may make follow-up or Investigation procedures inappropriate'}, 'identificationModule': {'nctId': 'NCT06471933', 'briefTitle': 'Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nordberg Medical AB'}, 'officialTitle': 'A Prospective, Single-Arm, Interventional, Multicenter, Post-Market Clinical Follow-up (PMCF) Investigation to Evaluate the Performance and Safety of Injectable Poly-LLactic Acid Dermal Filler for the Treatment of Nasolabial Fold Wrinkles', 'orgStudyIdInfo': {'id': 'NOR-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Juläine', 'interventionNames': ['Device: Juläine']}], 'interventions': [{'name': 'Juläine', 'type': 'DEVICE', 'description': 'Dermal filler (PLLA)', 'armGroupLabels': ['Juläine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Ribé clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'The Faculty', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "The IPD will not be shared due to the proprietary nature of the product under investigation, which is already commercialized. Sharing participant-level data could compromise competitive advantage and intellectual property, and therefore is not aligned with the sponsor's strategic interests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordberg Medical AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}