[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infraorbital-hollows\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infraorbital-hollows":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100612567","evaluation-of-facial-ha-dermal-fillers-in-real-life-conditions-100612567",false,"NCT07255261","Evaluation of Facial HA Dermal Fillers in Real-Life Conditions","Post-Marketing Clinical Follow Up On Hyaluronic Acid-Based Dermal Fillers Using COLD-X™ Technology By Symatese","Inclusion Criteria:\n\n* Subject seeking an aesthetic correction of the infraorbital hollows with FASY P and\u002F or an aesthetic correction of the lips with ESTYME® LIPS, and\u002F or an aesthetic correction of the perioral lines with ESTYME® SMOOTH, and\u002F or an aesthetic correction of nasolabial folds with ESTYME® SMOOTH, and\u002F or an aesthetic correction of cheeks with ESTYME® SCULPT.\n* Subject who agreed to participate and have signed an informed consent.\n* Age: over 18 years old.\n* Subject being affiliated to a health social security system.\n\nExclusion Criteria:\n\n* Minors\n* Subjects with a known allergy to hyaluronic acid, lidocaine or amide local anesthetics.\n* Subjects with porphyria.\n* Subjects with an autoimmune disorder, or using an immunosuppressant medication.\n* Pregnant or breastfeeding women.\n* Subjects with inflammation, infection or cutaneous disorders, at the treatment site or nearby.\n* Subjects with bleeding disorders or in subjects receiving thrombolytic or anticoagulant treatment.\n* Areas other than those recommended by the IFU.\n* Subject deprived of liberty by judicial or administrative decision.\n* Adults under a legal protection measure (guardianship\u002Fcuratorship).\n* Subject under legal protection order.",true,"ALL","18 Years",{"count":20,"type":21},460,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this post-market interventional study is to confirm, under real-life conditions, the safety and performance of hyaluronic acid-based dermal fillers intended to modify skin anatomy and facial appearance. Subjects aged 18 years or older seeking aesthetic treatment of the lips, perioral lines, nasolabial folds, cheeks, and\u002For infraorbital hollows may be included. The main question the study aims to answer is: How long does the effect of the products last?\n\nParticipants will attend follow-up visits every 6 months after the initial injection, until the end of follow-up at 24 months. During each visit, the investigator will assess performance and safety through a simple clinical examination. At each follow-up visit, subjects will also evaluate the aesthetic improvement compared with their pre-injection appearance. Subjects will be asked about the level of pain experienced during the initial injection.\n\nIf the subject wishes, a retreatment may be performed at the 12-month or 18-month follow-up visit, provided that the treated area(s) have returned to the pre-injection state.",[27,28,29,30,31],"Lips Enhancement","Perioral Wrinkles","Nasolabial Fold Wrinkles","Cheek Augmentation","Infraorbital Hollows","RECRUITING","2025-12-01",{"date":35,"type":36},"2025-12-08","ACTUAL",{"date":38,"type":36},"2025-07-02",{"date":40,"type":21},"2028-07",{"name":42,"class":43},"Symatese","INDUSTRY",8,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100573692","teosyal-rha-1-for-the-correction-of-moderate-to-severe-tissue-volume-deficiency-in-the-infraorbital-region-in-chinese-adults-100573692","NCT06749587","TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese Adults","A Prospective, Multi-center, Randomized, No-Treatment Controlled, Evaluator-Blinded, Superiority Clinical Investigation of the Safety and Effectiveness of TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese Adults","Inclusion Criteria:\n\n1. Chinese male and female, 18 years of age or older.\n2. Subject seeking treatment of moderate to severe tissue volume deficiencies in the infraorbital region.\n3. Subjects with a grade of 2 (moderate) or 3 (severe) on the TIOHS for both eyes, as determined on assessments by the Treating Investigator (TI) and BLE.\n4. Subject willing to abstain from all other facial aesthetic procedures\u002Ftherapies that could interfere with effectiveness evaluations (e.g., dermal fillers outside of this investigation, toxin treatments, facial ablative or fractional laser, Intense Pulsed Light \\[IPL\\], microdermabrasion, chemical peels, skin bleaching agents, non-ablative laser, or energy-based device for skin-tightening, surgical procedures, etc.) during participation in the investigation.\n5. Woman of childbearing potential agree to use contraception during the investigation.\n6. Subject understands and is able to follow instructions and complete all scheduled visits.\n7. Subjects who voluntarily decided to participate in the investigation and signed the informed consent.\n\nExclusion Criteria:\n\n1. Known hypersensitivity or previous allergic reaction to any component of the study device.\n2. Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.\n3. History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.\n4. History of connective tissue disease.\n5. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.\n6. Subjects who participated in other clinical investigation within 30 days, or in an exclusion period from a previous study.",{"count":53,"type":21},260,[24],"This is a prospective, multi-center, randomized, no-treatment controlled, evaluator-blinded clinical investigation to identify whether TEOSYAL RHA® 1 is superior to no treatment for the correction of moderate to severe tissue volume deficiencies in the infraorbital region in Chinese adults.\n\nEligible subjects will be enrolled and randomized either to the treatment group or control group in a 3:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL RHA® 1 in both Infraorbital Hollows (IOH), whereas subjects assigned to the control group will not receive any treatment.\n\nThe subjects in the treatment group will be treated with RHA1 for the treatment of moderate to severe tissue volume deficiencies in the infraorbital region on Day 0.\n\nAll treated subjects will return to the site at 2, 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and safety assessments. Each treated subjects will receive a safety phone call 3 days after the initial treatment at baseline, and after the touch-up treatment, if any. Their participation in the trial ends after the completion of the follow up period.\n\nAll non treated subjects (control group) will return to the site at 2, 4, and 12 weeks after randomization for effectiveness and safety assessments. Their participation in the investigation ends after the effectiveness and safety assessments at 12 weeks after randomization.",[31],[58,59],"Dermal Filler","Hyaluronic Acid","2025-01-24",{"date":62,"type":36},"2025-01-28",{"date":64,"type":36},"2024-12-12",{"date":66,"type":21},"2026-01-12",{"name":68,"class":43},"Teoxane SA",1]