[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100455783":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":21,"locations":30,"responsibleParty":42,"collaborators":44,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":21,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":21,"overallStatus":66,"whyStopped":21,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"GCS Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Gana V versus Sculptra","EXPERIMENTAL","Participants will receive both Gana V and Sculptra: one in each nasolabial folds",[13,14],"Device: Gana V®","Device: Sculptra®",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","Gana V®","Injection in the deep dermis and subcutaneous layer of the nasolabial fold on D0 (initial injection) and 1 month and a half after initial injection if necessary (optional touch-up).",[9],null,{"type":17,"name":23,"description":19,"armGroupLabels":24,"otherNames":21},"Sculptra®",[9],[26],{"name":27,"affiliation":28,"role":29},"Patricia Morel, Doctor","Eurofins Dermscan Pharmascan","PRINCIPAL_INVESTIGATOR",[31],{"facility":28,"status":21,"city":32,"state":21,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":21},"Villeurbanne","69100","France","FR",{"type":37,"coordinates":38},"Point",[39,40],4.8795,45.76601,{"lat":40,"lon":39},{"type":43,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[45],{"name":28,"class":6},"100455783","clinical-study-for-the-evaluation-of-the-safety-and-effectiveness-of-use-of-a-poly-l-lactic-acid-injectable-filler-for-the-aesthetic-treatment-of-nasolabial-folds-100455783",true,"NCT05215054","Clinical Study for the Evaluation of the Safety and Effectiveness of Use of a Poly-L Lactic Acid Injectable Filler for the Aesthetic Treatment of Nasolabial Folds","Clinical Study for the Safety and Effectiveness of Use of an Injectable Medical Device GANA V® for Facial Aesthetic Treatment","PLLA","Inclusion Criteria:\n\n* Subject with moderate to severe nasolabial folds as determined by a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 on both folds at the pre-treatment evaluation.\n* Subject wiling to abstain from other facial procedures (i.e., dermal fillers, toxin treatments, laser, microdermal abrasion, chemical peels, non-invasive skin-tightening) during the whole study period.\n* Subject, psychologically able to understand the study related information and to give a written informed consent.\n* Subject having given freely and expressly his\u002Fher informed consent.\n* Subject willing to have photographs of the face taken.\n* Subject affiliated to a health social security system.\n* Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit and during the whole study period.\n\nExclusion Criteria:\n\n* Pregnant or nursing woman or planning a pregnancy during the study.\n* Subject with a scar, moles, pigment disorders or anything on the face which might interfere with the evaluation.\n* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.\n* Subject in a social or sanitary establishment\n* Subject participation to another research on human beings or who is in an exclusion period of one.\n* Subject having received 4500 euros indemnities for participation in research involving human beings in the 12 previous months, including participation in the present study.\n* Subject suspected to be non-compliant according to the investigator's judgment.\n* Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.\n* Subject with known history of or suffering from autoimmune disease and\u002For immune deficiency.\n* Subject suffering from inflammatory and\u002For infectious cutaneous disorders in or near the studied zones (e.g. acne, mycosis, papilloma, chronic eczema, atopic dermatitis…). Subject with labial herpes in the last 2 years is not eligible even if asymptomatic at time of screening visit.\n* Subject with an abscess, unhealed wound, or a cancerous or precancerous lesion on the studied zone.\n* Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.\n* Subject with a tendency to develop keloids or hypertrophic scarring.\n* Subject having history of allergy or anaphylactic shock including hypersensitivity to Poly-l-lactic acid, to lidocaine or to one of the components of the tested devices or antiseptic solution.\n* Subject having received treatment with a laser, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the face within the past 12 months prior to screening visit.\n* Subject having received injection with a resorbable filling product in the face area within the past 12 months prior to screening visit.\n* Subject having received at any time injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of hyaluronic acid (HA) and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), …) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …) on the face.\n* Subject having received at any time a treatment with tensor threads on the face.\n* Subject having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to screening visit.\n* Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAID) (ibuprofen, naproxen, …), antiplatelet agents, anticoagulants or other substances known to prolong bleeding time within 1 week prior to injection visits.\n* Subject undergoing a topical treatment on the test area or a systemic treatment:\n\n  * Antihistamines during the 2 weeks prior to screening visit.\n  * Immunosuppressors and\u002For corticoids during the 4 weeks prior to screening visit.\n  * Retinoids during the 6 months prior to screening visit.\n* Intensive exposure to sunlight or UV-rays within the previous month before and after injection visits.","ALL","30 Years","70 Years",{"count":58,"type":59},59,"ACTUAL","INTERVENTIONAL",[62],"NA","The purpose of this study is to assess the effectiveness and safety of Gana V, a Poly L-lactic acid filler for the aesthetic treatment of nasolabial folds, in comparison with Sculptra.",[65],"Wrinkle","COMPLETED","2025-01-17",{"date":69,"type":59},"2025-01-20",{"date":71,"type":59},"2022-03-07",{"date":73,"type":59},"2024-05-07",{"name":5,"class":6},1]