[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610186":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":54,"collaborators":24,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":24,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":24,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":24,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"The Levine Center for Plastic Surgery","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Multi-Depth Ultherapy Prime Treatment","EXPERIMENTAL","Participants in this arm will receive a single full-face and neck Ultherapy Prime treatment delivered at multiple depths according to the manufacturer's guidelines for MFU-V energy placement. Energy will be applied using the appropriate transducers for each anatomical depth to target multiple layers of tissue beneath the skin surface. The goal is to stimulate collagen production at varying focal points to enhance lifting, tightening, and overall skin quality.",[13],"Device: Ultherapy Prime",{"label":15,"type":10,"description":16,"interventionNames":17},"Single-Depth Ultherapy Prime Treatment (1.5 mm)","Participants in this arm will receive a single full-face and neck Ultherapy Prime treatment delivered exclusively at the 1.5 mm depth, which is one of the FDA-cleared depths for treatment of the lower face and neck. This protocol evaluates whether single-depth energy delivery can achieve meaningful skin improvement compared with multi-layer treatment.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Ultherapy Prime","Ultherapy Prime is an FDA-cleared micro-focused ultrasound (MFU-V) device used for non-invasive lifting and tightening of the lower face, submentum, neck, brow, and improvement of décolleté lines. It delivers precise ultrasound energy at controlled depths to create thermal coagulation points that stimulate neocollagenesis, promoting new collagen and elastin for improved firmness and visible lifting. The system includes real-time DeepSEE® imaging to visualize tissue layers and ensure accurate energy placement. Ultherapy Prime uses transducers at FDA-cleared depths such as 1.5 mm, 2.0 mm, 3.0 mm, and 4.5 mm. For this study, treatment is delivered at multiple depths or only at 1.5 mm depending on randomization. It is non-surgical, non-ionizing, does not break the skin, and improvement develops gradually as collagen remodels.",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Jennifer Levine, MD","Principal Investigator","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Jennifer M Levine, MD","CONTACT","2125179400","info@drjenniferlevine.com",[37],{"facility":5,"status":38,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","New York","10075","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-74.00597,40.71427,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":52,"phoneExt":24,"email":53},"Amelia Adamska","212-517-9400","aadamska@drjenniferlevine.com",{"type":55,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100610186","long-term-efficacy-and-duration-of-mfu-v-at-multiple-depths-and-at-15-mm-100610186",false,"NCT07224308","Long-Term Efficacy and Duration of MFU-V at Multiple Depths and at 1.5 mm","Inclusion Criteria:\n\n* Male or female subjects between 25 and 65 years of age at the time of screening.\n\nPresence of moderate to severe laxity, fine lines, or crepiness of the lower face, submentum, and\u002For neck that is appropriate for improvement with non-invasive MFU-V treatment.\n\nSkin condition not advanced enough to require surgical correction.\n\nWillingness to refrain from elective aesthetic procedures involving the face, submentum, or neck for the entire 12-month duration of the study.\n\nAbility and willingness to comply with all study visits, procedures, and follow-up requirements.\n\nSufficient English language proficiency to understand study instructions and complete questionnaires.\n\nFor participants of childbearing potential: negative urine pregnancy test on the day of treatment and willingness to use adequate contraception during the study.\n\nAbility to provide written informed consent.\n\nExclusion Criteria:\n\n* Male or female subjects between 25 and 65 years of age at the time of screening.\n\nPresence of moderate to severe laxity, fine lines, or crepiness of the lower face, submentum, and\u002For neck that is appropriate for improvement with non-invasive MFU-V treatment.\n\nSkin condition not advanced enough to require surgical correction.\n\nWillingness to refrain from elective aesthetic procedures involving the face, submentum, or neck for the entire 12-month duration of the study.\n\nAbility and willingness to comply with all study visits, procedures, and follow-up requirements.\n\nSufficient English language proficiency to understand study instructions and complete questionnaires.\n\nFor participants of childbearing potential: negative urine pregnancy test on the day of treatment and willingness to use adequate contraception during the study.\n\nAbility to provide written informed consent.\n\nExclusion Criteria:\n\nActive systemic or local skin disease (e.g., eczema, psoriasis, dermatitis, infection) that may affect wound healing or the evaluation of results.\n\nScarring, tattoos, or significant pigmentary alterations in the planned treatment areas.\n\nMetallic implants or other implanted electronic devices (e.g., pacemakers) in or near the treatment area.\n\nOpen wounds, lesions, active herpes simplex, or active cystic\u002Fsevere inflammatory acne in the treatment area.\n\nUse of isotretinoin or other oral retinoids within the past 12 months or planned use during the study.\n\nMicrodermabrasion or medical-grade glycolic acid treatments to the treatment area within 2 weeks prior to participation.\n\nDeep dermal scarring, thick sebaceous skin, or severe solar elastosis in the treatment area that may interfere with treatment or evaluation.\n\nIntention to gain or lose ≥ 2 BMI units during the 12-month study period.\n\nKnown allergy or hypersensitivity to any component of the device or ultrasound coupling gel.\n\nHistory of chronic drug or alcohol abuse or opioid dependence.\n\nRecent aesthetic procedures to the lower face, submentum, or neck that may confound study outcomes (e.g., fillers, neurotoxins, lasers, threads, RF, ultrasound) within the protocol-specified washout period.\n\nParticipation in another clinical study involving an investigational device or drug within 30 days prior to treatment.\n\nPregnancy, breastfeeding, or plans to become pregnant during the study.\n\nAny condition that, in the opinion of the investigator, would increase risk or interfere with study participation or data interpretation.",true,"ALL","25 Years","65 Years",{"count":67,"type":68},20,"ESTIMATED","INTERVENTIONAL",[71],"NA","The goal of this clinical trial is to evaluate the long-term safety and effectiveness of Ultherapy Prime (MFU-V) for improving lines, wrinkles, laxity, and crepiness of the lower face, submentum, and neck. The study will enroll adult male and female subjects aged 25-65 with moderate to severe lower-face and neck skin laxity who are appropriate candidates for non-invasive ultrasound treatment.\n\nThe main questions this study aims to answer are:\n\nDoes Ultherapy Prime delivered at multiple depths compared to a single-depth (1.5 mm) treatment improve clinical lifting, tightening, and smoothing of the lower face and neck over a 12-month period?\n\nDoes treatment with Ultherapy Prime stimulate measurable improvements in collagen-related skin quality, patient satisfaction, and investigator-assessed aesthetic outcomes?\n\nBecause the study includes two treatment approaches, researchers will compare a multi-depth MFU-V treatment protocol versus a single-depth (1.5 mm) MFU-V treatment protocol to determine whether multi-depth energy delivery provides superior or longer-lasting clinical improvement.\n\nWhat Participants Will Do\n\nParticipants will:\n\nAttend a total of 5 study visits over 12 months (Screening\u002FTreatment, 1-month, 3-month, 6-month, and 12-month follow-ups).\n\nUndergo a single Ultherapy Prime treatment session at either multiple depths or at the 1.5 mm depth only.\n\nComplete standardized photography, including 2D and 3D images, at all timepoints.\n\nParticipate in clinical assessments, including GAIS scoring, cutometer elasticity measurements (if applicable), and investigator- and patient-reported satisfaction scales.\n\nFollow pre-visit requirements, including:\n\nNo moisturizers, lotions, or topical products on the treatment area before each visit\n\nNo hair in the treatment area (shave the day prior if needed)\n\nComplete questionnaires evaluating satisfaction, comfort, and perceived treatment benefits.\n\nAdhere to follow-up schedules, avoiding elective aesthetic procedures to the lower face, submentum, or neck during the study period.",[74],"Laxity; Skin","2025-10-31",{"date":77,"type":78},"2025-11-04","ACTUAL",{"date":80,"type":78},"2025-10-24",{"date":82,"type":68},"2026-12-30",{"name":5,"class":6},1]