[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lines-skin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lines-skin":30},{"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":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":43},"100610039","2910-nm-erbium-doped-fluoride-fiber-glass-laser-for-the-treatment-of-advanced-perioral-lines-and-wrinkles-100610039","NCT07222397","2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles","Evaluation of the 2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles","Inclusion Criteria:\n\n1. Fitzpatrick skin type I-IV.\n2. Male or female.\n3. Subjects must be between 50 and 80 years of age.\n4. Subjects must have the ability to receive up to two full face resurfacing laser treatment with specific focus on advanced perioral lines and wrinkles.\n5. Subjects must read, understand, and sign the Informed Consent Form.\n6. Subjects must be willing and able to comply with all follow-up visit requirements.\n7. Subjects must agree to refrain from using cosmeceutical agents or topical agents during the study, except as directed by study investigator.\n8. Subjects must be rated as Class II or Class III based on the Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS).\n9. Subject identified as an appropriate candidate for study treatment based on principal investigator's opinion.\n10. Subjects of childbearing potential have been on an acceptable form of contraception for 30 days prior to enrollment and agree to continue using throughout the course of the study.\n\nExclusion Criteria:\n\n1. Subjects must not have active localized or systemic infections.\n2. Subjects must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g., lupus, scleroderma, history of keloid scar formation), atrophic dermatitis or immunologic abnormalities such as vitiligo.\n3. Subjects must not have had treatments with 5FU, diclofenac, imiquimod, steroids, retinoids, or PDT within 1-month prior to enrollment.\n4. Subjects must not currently be taking Accutane or have taken Accutane within the last 1-month.\n5. Subjects must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications.\n6. Subjects must not have had previous surgery and\u002For fat transfer in the treatment area within the last 6-months.\n7. Subject must not have had injectable soft tissue fillers within the last 12 months in the treatment area.\n8. Subject must not have had Poly-L-Lactic acid (PLLA) fillers within the last 2 years in the treatment area.\n9. Subject must not have had permanent filler i.e., Polymethylmethacrylate (PMMA) in the treatment area.\n10. Subjects must not have had neurotoxins within the last 3-months in the treatment area.\n11. Subject must not have a personal history of any facial threads i.e., PDO (Polydioxanone), PLLA (Polylactic acid), PCL (Polycaprolactone) in the treatment area within the last 12 months.\n12. Subject must not have had a pulse dye or vascular laser, non-ablative laser, microneedling, or energy-based device treatment in the treatment area within the last 3 months.\n13. Subject must not have had an ablative laser treatment in the treatment area within the last 6 months.\n14. Subjects must not have a personal history of malignant melanoma, keloid scars, generalized psoriasis or systemic diseases that would preclude the use of topical anesthesia.\n15. Subject must not have active sunburn or excessively tanned skin.\n16. Subjects must not be pregnant or breastfeeding, think they may be pregnant or are trying to get pregnant during the study.","50 Years","80 Years",{"count":54,"type":22},20,[25],"The primary objective is to assess the efficacy, safety and satisfaction associated with the resurfacing treatment of perioral lines and wrinkles with the 2,910 nm mid-infrared Fiber Laser (UltraClear, Acclaro Medical) using both superficial epidermis ablation capabilities and the deep ablative and coagulative capabilities into the dermis for rejuvenation.\n\nParticipants will receive up to two treatments spaced 6-8 weeks apart, followed by a 1-month and 3-month follow-up visit during which the device will be evaluated for its effectiveness defined as improvement addressing perioral lines and wrinkles utilizing multiple scales completed by the investigator and blinded Independent Photographic Reviewers (IPRs). Additionally, safety, subjective overall aesthetic improvement and satisfaction will be monitored and tracked.",[58,59,30,60],"Photodamaged Skin","Rhytids","Wrinkles and Rhytides","2025-10-27",{"date":63,"type":35},"2025-10-29",{"date":65,"type":35},"2025-03-01",{"date":67,"type":22},"2026-02",{"name":69,"class":42},"FA Corporation"]