Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:00 AM
Study NCT ID:
NCT06454994
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate Safety and Effectiveness of Noble Lift® Lifting Threads
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': 'OTHER', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Hemi-face, intra-individual study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2024-06-06', 'studyFirstSubmitQcDate': '2024-06-06', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Global Aesthetic Improvement (GAIS) by the investigator between both products', 'timeFrame': 'Month 3', 'description': 'Non-inferiority of Noble Lift® threads in comparison with Croquis® thread, in terms of GAIS mean score on Month 3, assessed by an independent blinded investigator on photos (in global and for each indication). GAIS is a scale from 1 (worse) to 5 (very much improved).'}], 'secondaryOutcomes': [{'measure': 'Percentages of responders for Global Aesthetic Improvement (GAIS) by the investigator', 'timeFrame': 'Month 3, Month 6, Month 12', 'description': 'GAIS is a scale from 1 (worse) to 5 (very much improved)'}, {'measure': 'Percentages of responders for Global Aesthetic Improvement (GAIS) by the subject', 'timeFrame': 'Month 3, Month 6, Month 12', 'description': 'GAIS is a scale from 1 (worse) to 5 (very much improved)'}, {'measure': 'Change from baseline of Facial Laxity Rating Scale (FLRS) score', 'timeFrame': 'Month 3, Month 6, Month 12', 'description': 'FLRS is a scale from 1 (mild laxity) to 9 (severe laxity)'}, {'measure': 'Percentages of subjects satisfied with the intervention using a subjective evaluation questionnaire', 'timeFrame': 'Month 3, Month 6, Month 12', 'description': 'Answers are evaluated from 1 (very dissatisfied) to 5 (very satisfied)'}, {'measure': 'Number and percentages of immediate and early skin reactions collected by the subject', 'timeFrame': 'Month 1', 'description': 'Skin reactions are scored as mild, moderate or severe'}, {'measure': 'Number and percentages of skin reactions scored by the investigator', 'timeFrame': 'Month1, Month 3, Month 6, Month 12', 'description': 'Skin reactions are scored as mild, moderate or severe'}, {'measure': 'Number and percentages of Adverse Events', 'timeFrame': 'Month1, Month 3, Month 6, Month 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lifting threads', 'Eyebrow lift', 'Jaw laxity'], 'conditions': ['Aesthetic']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare two models of the Nobel Lift range (PDO sutures) with similar PDO devices available on the market, in a split-face comparative study. Each thread model will be used in one indication: upper face (eyebrow lift) or mid-face and lower-face.\n\nAesthetic efficacy of the devices will be evaluated and compared with the Global Aesthetic Improvement Scale (GAIS), jowl laxity scale, subjective evaluation of the patient and photographs during a 12-months period. Safety of the devices and procedures will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI comprised between 18.5 and 30\n* No ongoing or planned diet.\n* Group 1: requiring an aesthetic treatment of upper face with resorbable threads.\n* Group 2: Subject requiring an aesthetic treatment of mid-face and lower-face with resorbable threads\n* Subject with dense and not too thin skin.\n\nExclusion Criteria:\n\n* Pregnant or nursing woman or planning a pregnancy during the study;\n* Suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study result and/or subject safety, especially cardiac disorder, non-controlled high blood pressure, diabetes, panic disorders, depression, active auto-immune disease, cold, high fever,…\n* Suffering from malnutrition.\n* Acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events.\n* Wound healing disorder or with a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.\n* History of precancerous lesions/skin malignancies.\n* Active skin disease within 6 months of study entry.\n* Scars, rosacea, herpes, acne, blotches or other pathology in the face, at the investigator appreciation.\n* Predisposed to keloidosis or hypertrophic scarring.\n* Known history of hyper- or hypo-pigmentation in the face.\n* Known history of multiple allergies, allergic/anaphylactic reactions including allergy/ hypersensitivity to lidocaine, anaesthetics of the amide type, the used antiseptic components, the used antibiotic cream components.\n* Known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment.\n* Extensive skin laxity, thin skin and/or severe malar fat sagging.\n* Foreign body sensitivity or known or suspected allergies to implant or instrument materials in particular plastic/biomaterial.\n* Any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety/tolerance.\n* Dental care in the past 2 weeks or who planned to receive dental care in the 2 months after the treatment.\n* Anticoagulant (such as aspirin, warfarin, blood circulation enhancer and clotbuster) during the week before the injection session .\n* Chemotherapy agents, immunosuppressive medications or systemic corticosteroids in the past 3 months and during the study.\n* Lifting of the face in the past 12 months or other surgery of the face in the past 6 months.\n* Resorbable fillers within the past 12 months, other resorbable threads within the past 12 months, neurotoxin in the past 5 months or plans to receive such treatments during the study.\n* Permanent filler on the face.\n* Subcutaneous permanent retaining structure on the face (meshing, permanent threads, gold strand etc.).\n* Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study.'}, 'identificationModule': {'nctId': 'NCT06454994', 'briefTitle': 'Clinical Study to Evaluate Safety and Effectiveness of Noble Lift® Lifting Threads', 'organization': {'class': 'INDUSTRY', 'fullName': 'GCS Co., Ltd'}, 'officialTitle': 'A Prospective, Multicentric, Comparative, Split-face Clinical Study to Evaluate Safety and Effectiveness of Noble Lift® Lifting Threads', 'orgStudyIdInfo': {'id': '23E1359'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Noble Lift threads', 'interventionNames': ['Device: Eyebrow lift', 'Device: Jaw lift']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Croquis threads', 'interventionNames': ['Device: Eyebrow lift', 'Device: Jaw lift']}], 'interventions': [{'name': 'Eyebrow lift', 'type': 'DEVICE', 'description': 'Upper face lifting', 'armGroupLabels': ['Croquis threads', 'Noble Lift threads']}, {'name': 'Jaw lift', 'type': 'DEVICE', 'description': 'Mid-face and low-face lifting', 'armGroupLabels': ['Croquis threads', 'Noble Lift threads']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aix-en-Provence', 'country': 'France', 'contacts': [{'name': 'Gérard Jeanblanc', 'role': 'CONTACT'}], 'facility': 'Dr Jeanblanc', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'city': 'Cannes', 'country': 'France', 'contacts': [{'name': 'Jean-Marc Facchinetti', 'role': 'CONTACT'}], 'facility': 'Dr Facchinetti', 'geoPoint': {'lat': 43.55135, 'lon': 7.01275}}, {'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Sophie Converset-Viethel', 'role': 'CONTACT'}], 'facility': 'Dr Converset-Viethel', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Christian Lemmel', 'role': 'CONTACT'}, {'name': 'Jean-Jacques Deutsch', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Dr Lemmel', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Audrey Natalizio', 'role': 'CONTACT', 'email': 'audrey.natalizio@cpt.eurofinseu.com', 'phone': '+33 4 72 82 36 56'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GCS Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eurofins Laboratoire Dermscan', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}