[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lax-skin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lax-skin":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100607341","a-prospective-controlled-study-to-evaluate-the-safety-and-effectiveness-of-thermage-flx-radiofrequency-treatment-100607341",false,"NCT07187297","A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment","A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment to Improve Lines and Wrinkles and to Lift and Tighten Lax Tissue in the Neck, Abdomen, Upper Arms, and Face","Inclusion Criteria:\n\n* Be an adult female or male, ≥30 - ≤60 years of age.\n\nHave mild-to-moderate skin laxity of the neck, abdomen, upper arms, and\u002For face, and\u002For mild-to-moderate lines and\u002For wrinkles of the neck and\u002For face assessed as follows:\n\nNeck:\n\nMild-to-moderate neck skin laxity as defined by a score of 1 to 6 on the 10-point Facial Laxity Rating Scale (scored 0-9)\n\nMild-to-moderate neck wrinkles as defined by a score of 1 to 6 on the 10-point Fitzpatrick Wrinkle Scale (scored 0-9)\n\nAbdomen:\n\nMild-to-moderate abdomen skin laxity as defined by a score of 1 or 2 on a 4-point Abdominal Laxity Scale (scored 0-3)\n\nUpper arms:\n\nMild to moderate upper arms skin laxity as defined by grade 2 or 3 on the 5-grade IBSA Inner Upper Arm Laxity Scale\n\nFace:\n\nMild-to-moderate facial skin laxity as defined by a score of 1 to 6 on the 10-point Facial Laxity Rating Scale (scored 0-9)\n\nMild-to-moderate facial wrinkles as defined by a score of 1 to 6 on the 10-point Fitzpatrick Wrinkle Scale (scored 0-9)\n\nFemales of childbearing potential must have a negative urine pregnancy test. Females who have experienced menarche and who are not postmenopausal (either confirmed via FSH testing or who have not menstruated for 2 years or more without an alternative medical cause) or surgically sterile will be considered of childbearing potential.\n\nFemales of childbearing potential must agree to use an acceptable method of birth control for the duration of the study. Acceptable methods of birth control are oral and other systemic contraceptives, condoms only, intrauterine device, double-barrier methods, bilateral tubal ligation, partner vasectomy, and abstinence.\n\nHave no clinically abnormal findings based on the medical history as determined by the study investigator.\n\nBe able to follow the study instructions, be available on the specific required study visit days, and be willing to complete all study visit procedures and assessments.\n\nUnderstand the research nature of this study and sign an informed consent document prior to the performance of any study-specific procedure or assessment.\n\nAgree to not undergo excluded procedures (i.e., energy-based device treatments, injectables, or plastic surgery) on the study treatment areas for the duration of study.\n\nParticipant has a body mass index (BMI) ≤30.\n\nExclusion Criteria:\n\n* Participant is pregnant or breast feeding or trying to become pregnant for 3 months prior to the screening visit or during the study.\n\nParticipant has given birth within 3 months prior to the screening visit.\n\nParticipant has an anticipated need for procedures, surgery, overnight hospitalization, or other events that would prevent the participant from making the required visits during the study.\n\nParticipant has a pacemaker, internal defibrillator, or other implanted electronic device.\n\nParticipant has an implant in the target treatment zone(s).\n\nParticipant has had radiation therapy in the target treatment zone(s).\n\nParticipant has had 1 or more prior cosmetic procedures in the target treatment zone(s) including:\n\nThermage or any energy-based device procedure, derm abrasion, or chemical peel on any treatment area within 6 months prior to the screening visit.\n\nShort-acting neurotoxins within 6 months prior to the screening visit.\n\nLong-acting neurotoxins within 9 months prior to the screening visit.\n\nHyaluronic acid filler ≤1 year prior to the screening visit.\n\nSemi-permanent or permanent fillers at any time prior to the screening visit.\n\nPlastic surgery within 1 year prior to the screening visit.",true,"ALL","30 Years","60 Years",{"count":21,"type":22},164,"ESTIMATED","INTERVENTIONAL",[25],"NA","A prospective, 180-day, randomized, multicenter, independent blinded evaluators, controlled study of treatment with the Thermage FLX System",[28,29,30],"Wrinkle","Lax Skin","Lines Skin","RECRUITING","2025-12-15",{"date":34,"type":35},"2025-12-17","ACTUAL",{"date":37,"type":35},"2025-10-31",{"date":39,"type":22},"2027-03",{"name":41,"class":42},"Bausch Health Americas, Inc.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":16,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":5},"100541684","treatment-to-lift-facial-lax-skin-and-improve-facial-wrinkles-using-precise-and-lift-applicators-100541684","NCT06333067","Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators","Safety and Efficacy of SofWave Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators","Inclusion Criteria:\n\n1. Healthy female and male subjects between the ages 35-80.\n2. Non-Smoker.\n3. Fitzpatrick skin type I-VI.\n4. Desire to lift facial lax skin, neck and\u002For submental and\u002For to lift the eyebrow area and\u002For improve facial wrinkles appearance.\n5. Able and willing to comply with all visits, treatments and evaluation schedules and requirements.\n6. Able to understand and provide written Informed Consent.\n7. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.\n8. Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment.\n9. Stable weight over the last 12 weeks and throughout the duration of the study.\n\nExclusion Criteria:\n\n* 1\\. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and\u002For breast feeding.\n\n  2\\. Presence of any active systemic or local infections.\n\n  3\\. Presence of active local skin disease that may alter wound healing.\n\n  4\\. Severe solar elastosis.\n\n  5\\. Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the past 10 years.\n\n  6\\. History of chronic drug or alcohol abuse.\n\n  7\\. Excessive subcutaneous fat on the cheeks.\n\n  8\\. Significant scarring in the area to be treated.\n\n  9\\. Severe or cystic facial acne, and\u002For Accutane use during past 6 months.\n\n  10\\. Presence of a metal stent or implant in the facial area (dental implants and\u002For braces are not excluded).\n\n  11\\. Inability to understand the protocol or to provide a signed informed consent.\n\n  12\\. History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past 6 months; injectable (Botox or fillers) of any type within the past 6 months; ablative or non-ablative resurfacing\u002Frejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep facial peels within the past 12 months; facelift, blepharoplasty, or brow lift (including contour threads) within the past 12 months.\n\n  13\\. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.\n\n  14\\. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.","35 Years","80 Years",{"count":54,"type":22},100,[25],"Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.",[29],[59,60,61,62],"neck zones.","submental","Facial","Skin laxity","2025-05-12",{"date":65,"type":35},"2025-05-13",{"date":67,"type":35},"2023-10-11",{"date":69,"type":22},"2025-11-01",{"name":71,"class":42},"Sofwave Medical LTD"]