[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607341":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":35,"responsibleParty":53,"collaborators":25,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":25,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":25,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Bausch Health Americas, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Arm","ACTIVE_COMPARATOR","Treated with Thermage FLX device at day 90",[13],"Device: Thermage FLX",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment Arm","EXPERIMENTAL","Treated with Thermage FLX device at day 1",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Thermage FLX","The Thermage FLX System ('System') is a monopolar, capacitively coupled radiofrequency System designed for use in non-invasive dermatological procedures",[9,15],null,[27,32],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Sandra Narain","CONTACT","9082428287","sandra.narain@bauschhealth.com",{"name":33,"role":29,"phone":25,"phoneExt":25,"email":34},"Caitlin Little","caitlin.little@premier-research.com",[36],{"facility":37,"status":38,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Union Square Laser Dermatology","RECRUITING","New York","10003","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-74.00597,40.71427,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":25,"phoneExt":25,"email":52},"Anne Chapas","research@unionderm.com",{"type":54,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":67,"type":68},164,"ESTIMATED","INTERVENTIONAL",[71],"NA","A prospective, 180-day, randomized, multicenter, independent blinded evaluators, controlled study of treatment with the Thermage FLX System",[74,75,76],"Wrinkle","Lax Skin","Lines Skin","2025-12-15",{"date":79,"type":80},"2025-12-17","ACTUAL",{"date":82,"type":80},"2025-10-31",{"date":84,"type":68},"2027-03",{"name":5,"class":6},1]