[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"skin-laxity-submental-and-neck\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:skin-laxity-submental-and-neck":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100651473","safety-and-efficacy-of-a-2910-nm-fractional-ablative-fiber-laser-ultraclear-for-improvements-of-skin-laxity-and-lifting-of-the-lower-face-submental-and-neck-treatment-areas-100651473",false,"NCT07759817","Safety and Efficacy of a 2,910 nm Fractional Ablative Fiber Laser (UltraClear®) for Improvements of Skin Laxity and Lifting of the Lower Face, Submental, and Neck Treatment Areas","UC 29-2026","Inclusion Criteria:\n\n1. Fitzpatrick skin types I-III participants with Fitzpatrick Skin Types IV-VI may be enrolled only at the investigator's discretion, based on individualized risk assessment documenting skin tone-related risk of post-inflammatory hyperpigmentation, wound healing history, and prior response to ablative or energy-based treatments. Risk assessment documentation must be retained in the participant's study file. Male or female.\n2. Participants must be between 35 and 65 years of age.\n3. Participants must have the ability to receive two lower face and full neck resurfacing laser treatments with desire for improvement in lifting and skin laxity.\n4. Participants must read, understand, and sign the Informed Consent Form.\n5. Participants must be willing and able to comply with all follow-up visit requirements.\n6. Participants must agree to refrain from using cosmeceutical agents or topical agents during the study, except as directed by study investigator.\n7. Participants must be rated as (2) Moderate Sagging to (4) Very Severe Sagging based on the Merz Jawline Grading Scale (MJGS)\\[11\\].\n8. Participants must be rated as a (C) Grade 3: moderate laxity, (D) Grade 4: moderate to severe laxity or (E) Grade 5: severe laxity of the tissues of the neck based on the 5-Grade IBSA Neck Laxity Scale \\[12\\]\n9. Participants of childbearing potential must 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.\n10. Participants agree to maintain stable body weight, defined as no planned weight-loss program and no significant change in body weight (±10 lbs or ±5%) within 3 months prior to enrollment and throughout study participation.\n11. Participants identified as an appropriate candidate for study treatment based on principal investigator's opinion.\n\nExclusion Criteria:\n\n1. Participants must not have active localized or systemic infections.\n2. Participants 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), atopic dermatitis or immunologic abnormalities such as vitiligo.\n3. Participants must not be current smoker or have history of regular tobacco or nicotine use within 12 months prior to enrollment.\n4. Participants must not have had treatments with systemic steroids or systemic retinoids in the 4-months prior to enrollment.\n5. Participants must not have had treatments with 5FU, diclofenac, imiquimod or PDT within 1-month prior to enrollment.\n6. Participants must not have severe or cystic facial acne; currently taking Accutane or have taken Accutane within the last 1-month.\n7. Participants must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications.\n8. Participants must not have had previous surgery and\u002For fat transfer in the treatment area within the last 6-months.\n9. Participant must not have had injectable soft tissue fillers within the last 12-months in the treatment area.\n10. Participant must not have had Poly-L-Lactic acid (PLLA) or Calcium Hydroxylapatite (CaHA) fillers within the last 2 years in the treatment area.\n11. Participant must not have had permanent filler i.e., Polymethylmethacrylate (PMMA) in the treatment area.\n12. Participants must not have had neurotoxins within the last 4-months in the treatment area.\n13. Participant 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.\n14. Participant must not have had a pulse dye or vascular laser, non-ablative laser, microneedling or RF microneedling treatments in the treatment area within the last 3-months.\n15. Participant must not have had an ultrasound treatment such as HIFU, monopolar RF energy-based devices, ablative laser treatments in the treatment area within the last 6-months.\n16. Participants must not have a personal history of malignant melanoma, keloid scars, generalized psoriasis or systemic diseases that would preclude the use of topical anesthesia.\n17. Participant must not have active sunburn or excessively tanned skin.\n18. Participants must not be pregnant or planning to become pregnant, have given birth less than 3-months ago, and\u002For breastfeeding during the study. Participants of childbearing potential will be asked to confirm they are not pregnant at screening, at each treatment visit and at Visit 6: Day 139 ± 7 days (3-month follow-up) representing approximately 90 days following the second treatment and Visit 7: Day 229 ± 7 days (6-month follow-up).",true,"ALL","35 Years","65 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study evaluates the safety and effectiveness of the UltraClear® 2,910 nm fractional ablative fiber laser for improving skin laxity and tissue lifting in the lower face, submental, and neck areas. Up to 50 adults ages 35-65 will receive two laser treatments approximately 7 weeks apart at two clinical sites. Outcomes will be assessed approximately 90 days after the second treatment using photographic analysis and investigator- and participant-reported improvement scales.",[28,29],"Skin Laxity (Submental and Neck)","Skin Lifting and Tightening","NOT_YET_RECRUITING","2026-08-09",{"date":33,"type":34},"2026-08-12","ACTUAL",{"date":36,"type":22},"2026-08-07",{"date":38,"type":22},"2027-08-31",{"name":40,"class":41},"FA Corporation","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100610580","safety-and-effectiveness-evaluation-of-the-high-intensity-focused-ultrasound-device-for-lifting-lax-submental-and-neck-tissue-100610580","NCT07229430","Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue","A Prospective, Multi-center, Randomized Controlled, Non-inferiority Study to Evaluate the Safety and Effectiveness of ULTRAFORMER MPT PLUS Treatment to Lift Lax Submental (Beneath the Chin) and Neck Tissue","Inclusion Criteria:\n\n1. Male or female subjects aged 30 to 65 years, inclusive, at the time of informed consent.\n2. Subjects presenting with mild to moderate submental and\u002For neck skin laxity, as determined by the investigator.\n3. Subjects in good general health with stable body weight (±5%) for at least 6 months prior to screening.\n4. Subjects willing to avoid other aesthetic or dermatologic procedures (surgical or non-surgical) to the treatment area during the study period.\n5. Subjects able to understand and sign informed consent and comply with all study visits and procedures.\n6. Female subjects of child-bearing potential who agree to use reliable contraception throughout study participation.\n\nExclusion Criteria:\n\n1. Prior facelift, neck lift, liposuction, or contouring surgery involving the lower face, submental, or neck areas.\n2. Receipt of any energy-based aesthetic treatment (e.g., HIFU, radiofrequency, laser) or injectable aesthetic treatment (e.g., botulinum toxin, dermal filler, collagen stimulator) to the treatment area within 6 months prior to baseline.\n3. Presence of any implanted electronic medical device, such as a pacemaker, defibrillator, or neurostimulator.\n4. Active skin infection, wound, cystic acne, inflammation, or severe scarring within or near the treatment area.\n5. History of keloid formation or abnormal wound healing.\n6. Known bleeding disorder, or use of anticoagulant or antiplatelet medications that cannot be safely discontinued for the procedure.\n7. Pregnant or breastfeeding women.\n8. Subjects with a known sensitivity or contraindication to ultrasound-based procedures.\n9. Any medical or psychiatric condition that, in the investigator's judgment, could interfere with study participation, safety, or data integrity.\n10. Participation in another investigational study within 30 days prior to screening.","30 Years",{"count":51,"type":22},273,[25],"This is a prospective, multicenter, randomized, evaluator-blinded, parallel-controlled, non-inferiority clinical study designed to evaluate the safety and effectiveness of the ULTRAFORMER MPT PLUS, a high-intensity focused ultrasound (HIFU) device, for lifting and tightening lax submental (beneath the chin) and neck tissue in adult subjects.\n\nApproximately 273 subjects will be enrolled at multiple investigational sites across the United States.\n\nParticipants will receive either the ULTRAFORMER MPT PLUS treatment or the predicate comparator device, and will be followed for safety and efficacy assessments including clinical photography, investigator evaluation, and patient-reported outcomes.\n\nThe study aims to demonstrate that ULTRAFORMER MPT PLUS is non-inferior to the approved reference device in improving skin laxity and wrinkle appearance of the lower face and neck.",[28,55,56],"Facial Skin Laxity","Submental Tissue Laxity",[58,59,60,61,62,63,64,65,66],"ULTRAFORMER MPT PLUS","High-Intensity Focused Ultrasound","HIFU","Submental Lifting","Skin Laxity","Non-surgical Lift","Aesthetic Device","Classys","Non-Inferiority Clinical Trial","RECRUITING","2026-04-16",{"date":70,"type":34},"2026-04-20",{"date":72,"type":34},"2025-10-16",{"date":74,"type":22},"2026-11-26",{"name":76,"class":41},"CLASSYS Inc.",5]