Laxity; SkinNCT07224308
Long-Term Efficacy and Duration of MFU-V at Multiple Depths and at 1.5 mm
A study testing Ultherapy Prime in people with Laxity; Skin, run by The Levine Center for Plastic Surgery at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laxity; Skin
- What is being tested?
- Ultherapy Prime
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects between 25 and 65 years of age at the time of screening.
- Presence of moderate to severe laxity, fine lines, or crepiness of the lower face, submentum, and/or neck that is appropriate for improvement with non-invasive MFU-V treatment.
- Skin condition not advanced enough to require surgical correction.
- Willingness to refrain from elective aesthetic procedures involving the face, submentum, or neck for the entire 12-month duration of the study.
- Ability and willingness to comply with all study visits, procedures, and follow-up requirements.
- Sufficient English language proficiency to understand study instructions and complete questionnaires.
- For participants of childbearing potential: negative urine pregnancy test on the day of treatment and willingness to use adequate contraception during the study.
- Ability to provide written informed consent.
Who cannot join
- Male or female subjects between 25 and 65 years of age at the time of screening.
- Presence of moderate to severe laxity, fine lines, or crepiness of the lower face, submentum, and/or neck that is appropriate for improvement with non-invasive MFU-V treatment.
- Skin condition not advanced enough to require surgical correction.
- Willingness to refrain from elective aesthetic procedures involving the face, submentum, or neck for the entire 12-month duration of the study.
- Ability and willingness to comply with all study visits, procedures, and follow-up requirements.
- Sufficient English language proficiency to understand study instructions and complete questionnaires.
Show all 22Show fewer
- For participants of childbearing potential: negative urine pregnancy test on the day of treatment and willingness to use adequate contraception during the study.
- Ability to provide written informed consent.
- Active systemic or local skin disease (e.g., eczema, psoriasis, dermatitis, infection) that may affect wound healing or the evaluation of results.
- Scarring, tattoos, or significant pigmentary alterations in the planned treatment areas.
- Metallic implants or other implanted electronic devices (e.g., pacemakers) in or near the treatment area.
- Open wounds, lesions, active herpes simplex, or active cystic/severe inflammatory acne in the treatment area.
- Use of isotretinoin or other oral retinoids within the past 12 months or planned use during the study.
- Microdermabrasion or medical-grade glycolic acid treatments to the treatment area within 2 weeks prior to participation.
- Deep dermal scarring, thick sebaceous skin, or severe solar elastosis in the treatment area that may interfere with treatment or evaluation.
- Intention to gain or lose ≥ 2 BMI units during the 12-month study period.
- Known allergy or hypersensitivity to any component of the device or ultrasound coupling gel.
- History of chronic drug or alcohol abuse or opioid dependence.
- Recent 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.
- Participation in another clinical study involving an investigational device or drug within 30 days prior to treatment.
- Pregnancy, breastfeeding, or plans to become pregnant during the study.
- Any condition that, in the opinion of the investigator, would increase risk or interfere with study participation or data interpretation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Levine Center for Plastic Surgery
New York, New York, 10075
Amelia Adamska, 212-517-9400, aadamska@drjenniferlevine.com
About this study
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.
The main questions this study aims to answer are:
Read more
Does 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?
Does treatment with Ultherapy Prime stimulate measurable improvements in collagen-related skin quality, patient satisfaction, and investigator-assessed aesthetic outcomes?
Because 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.
What Participants Will Do
Participants will:
Attend a total of 5 study visits over 12 months (Screening/Treatment, 1-month, 3-month, 6-month, and 12-month follow-ups).
Undergo a single Ultherapy Prime treatment session at either multiple depths or at the 1.5 mm depth only.
Complete standardized photography, including 2D and 3D images, at all timepoints.
Participate in clinical assessments, including GAIS scoring, cutometer elasticity measurements (if applicable), and investigator- and patient-reported satisfaction scales.
Follow pre-visit requirements, including:
No moisturizers, lotions, or topical products on the treatment area before each visit
No hair in the treatment area (shave the day prior if needed)
Complete questionnaires evaluating satisfaction, comfort, and perceived treatment benefits.
Adhere to follow-up schedules, avoiding elective aesthetic procedures to the lower face, submentum, or neck during the study period.
Read the detailed description
This study is a prospective, single-center clinical trial designed to evaluate the long-term safety and effectiveness of Ultherapy Prime (MFU-V) for improving lines, wrinkles, and skin laxity of the lower face, submentum, and neck. Ultherapy Prime is an FDA-cleared focused ultrasound device indicated for non-invasive lifting and tightening of the skin under the chin, on the neck, and on the brow, as well as for improving lines and wrinkles of the décolleté. The device delivers precise micro-focused ultrasound energy at controlled depths beneath the skin's surface to stimulate neocollagenesis-the natural production of new collagen that contributes to skin firmness, elasticity, and support.
The objective of this study is to assess clinical outcomes following a single Ultherapy Prime treatment using either a multi-depth protocol or a single-depth protocol at 1.5 mm. The study will enroll 20 adult subjects aged 25 to 65 with moderate to severe laxity or crepiness of the lower face and neck who are appropriate candidates for non-invasive energy-based treatment.
Participants will be randomized to receive Ultherapy Prime at either multiple treatment depths or at the 1.5 mm depth alone. All subjects will undergo standardized 2D and 3D digital photography, clinical assessments, and patient-reported outcome measures over a 12-month follow-up period. Investigator-assessed and patient-reported evaluations-including the Global Aesthetic Improvement Scale (GAIS), cutometer elasticity measurements (if applicable), and satisfaction scales-will be used to assess changes in skin quality, lifting, tightening, and overall aesthetic improvement.
The study includes five visits: a combined Screening/Treatment Visit, and follow-up visits at 1 month, 3 months, 6 months, and 12 months post-treatment. The Screening/Treatment Visit will include informed consent, eligibility confirmation, pregnancy testing if applicable, baseline imaging, and delivery of the assigned Ultherapy Prime treatment. Participants must avoid applying any lotions, moisturizers, or topical products to the treatment area prior to each visit. The treatment area must be free of hair; if shaving is required, participants must shave the day before treatment.
To reduce confounding variables, subjects must refrain from undergoing elective aesthetic procedures involving the lower face, submentum, or neck for the duration of the 12-month study. Safety will be monitored throughout the trial through documentation of adverse events, subject-reported symptoms, and clinical examinations. Because Ultherapy Prime is already FDA-cleared for the anatomical regions being treated, and because treatment involves a single non-invasive procedure, the study is considered minimal risk.
This research will contribute to a deeper understanding of the duration and extent of clinical benefits associated with Ultherapy Prime, as well as whether multi-depth treatment results in greater or longer-lasting improvement compared to treatment at a single depth.
- Conditions
- Laxity; Skin
- Being tested
- Ultherapy Prime
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultherapy PrimeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ultherapy Prime |
| Single-Depth Ultherapy Prime Treatment (1.5 mm) | Experimental | 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. Receives: Device: Ultherapy Prime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skin Laxity and Wrinkle Severity of the Lower Face and Neck
Clinical improvement in skin laxity, lines, and wrinkles of the lower face, submentum, and neck will be assessed by the Principal Investigator using the Global Aesthetic Improvement Scale (GAIS) and standardized 2D/3D photographs. The primary endpoint evaluates whether treatment with Ultherapy Prime results in a measurable improvement in lifting, tightening, and skin smoothness compared with baseline. GAIS scores range from "Very Much Improved" to "Worse," with higher ratings indicating greater aesthetic improvement.
Measured: Baseline to 3 months post-treatment
Secondary outcomes (1)
Change in Skin Laxity, Lines, and Wrinkle Severity at 6 and 12 Months
Evaluation of whether aesthetic improvement persists at 12 months using GAIS, photography, and patient satisfaction surveys to assess the duration of clinical benefit following a single MFU-V treatment.
Measured: Baseline to 6 months, and Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start24 Oct 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laxity; SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Levine Center for Plastic Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Levine, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224308
- Sponsor's protocol ID
- IIT10912
- Status last verified
- Oct 2025
- First submitted
- 31 Oct 2025
- Last updated
- 4 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Efficacy and Duration of MFU-V at Multiple Depths and at 1.5 mm
- ClinicalTrials.gov ID
- NCT07224308
- Acronym / sponsor ID
- IIT10912
- Conditions
- Laxity; Skin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Levine Center for Plastic SurgeryUniversity, hospital or other
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The main questions this study aims to answer are:
Does 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?
Does treatment with Ultherapy Prime stimulate measurable improvements in collagen-related skin quality, patient satisfaction, and investigator-assessed aesthetic outcomes?
Because 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.
What Participants Will Do
Participants will:
Attend a total of 5 study visits over 12 months (Screening/Treatment, 1-month, 3-month, 6-month, and 12-month follow-ups).
Undergo a single Ultherapy Prime treatment session at either multiple depths or at the 1.5 mm depth only.
Complete standardized photography, including 2D and 3D images, at all timepoints.
Participate in clinical assessments, including GAIS scoring, cutometer elasticity measurements (if applicable), and investigator- and patient-reported satisfaction scales.
Follow pre-visit requirements, including:
No moisturizers, lotions, or topical products on the treatment area before each visit
No hair in the treatment area (shave the day prior if needed)
Complete questionnaires evaluating satisfaction, comfort, and perceived treatment benefits.
Adhere to follow-up schedules, avoiding elective aesthetic procedures to the lower face, submentum, or neck during the study period.
Detailed description
This study is a prospective, single-center clinical trial designed to evaluate the long-term safety and effectiveness of Ultherapy Prime (MFU-V) for improving lines, wrinkles, and skin laxity of the lower face, submentum, and neck. Ultherapy Prime is an FDA-cleared focused ultrasound device indicated for non-invasive lifting and tightening of the skin under the chin, on the neck, and on the brow, as well as for improving lines and wrinkles of the décolleté. The device delivers precise micro-focused ultrasound energy at controlled depths beneath the skin's surface to stimulate neocollagenesis-the natural production of new collagen that contributes to skin firmness, elasticity, and support.
The objective of this study is to assess clinical outcomes following a single Ultherapy Prime treatment using either a multi-depth protocol or a single-depth protocol at 1.5 mm. The study will enroll 20 adult subjects aged 25 to 65 with moderate to severe laxity or crepiness of the lower face and neck who are appropriate candidates for non-invasive energy-based treatment.
Participants will be randomized to receive Ultherapy Prime at either multiple treatment depths or at the 1.5 mm depth alone. All subjects will undergo standardized 2D and 3D digital photography, clinical assessments, and patient-reported outcome measures over a 12-month follow-up period. Investigator-assessed and patient-reported evaluations-including the Global Aesthetic Improvement Scale (GAIS), cutometer elasticity measurements (if applicable), and satisfaction scales-will be used to assess changes in skin quality, lifting, tightening, and overall aesthetic improvement.
The study includes five visits: a combined Screening/Treatment Visit, and follow-up visits at 1 month, 3 months, 6 months, and 12 months post-treatment. The Screening/Treatment Visit will include informed consent, eligibility confirmation, pregnancy testing if applicable, baseline imaging, and delivery of the assigned Ultherapy Prime treatment. Participants must avoid applying any lotions, moisturizers, or topical products to the treatment area prior to each visit. The treatment area must be free of hair; if shaving is required, participants must shave the day before treatment.
To reduce confounding variables, subjects must refrain from undergoing elective aesthetic procedures involving the lower face, submentum, or neck for the duration of the 12-month study. Safety will be monitored throughout the trial through documentation of adverse events, subject-reported symptoms, and clinical examinations. Because Ultherapy Prime is already FDA-cleared for the anatomical regions being treated, and because treatment involves a single non-invasive procedure, the study is considered minimal risk.
This research will contribute to a deeper understanding of the duration and extent of clinical benefits associated with Ultherapy Prime, as well as whether multi-depth treatment results in greater or longer-lasting improvement compared to treatment at a single depth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-Depth Ultherapy Prime Treatment | Experimental | Device: Ultherapy PrimeParticipants 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. |
| Single-Depth Ultherapy Prime Treatment (1.5 mm) | Experimental | Device: Ultherapy PrimeParticipants 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects between 25 and 65 years of age at the time of screening.
- Presence of moderate to severe laxity, fine lines, or crepiness of the lower face, submentum, and/or neck that is appropriate for improvement with non-invasive MFU-V treatment.
- Skin condition not advanced enough to require surgical correction.
- Willingness to refrain from elective aesthetic procedures involving the face, submentum, or neck for the entire 12-month duration of the study.
- Ability and willingness to comply with all study visits, procedures, and follow-up requirements.
Key exclusion criteria (22 listed)
- Male or female subjects between 25 and 65 years of age at the time of screening.
- Presence of moderate to severe laxity, fine lines, or crepiness of the lower face, submentum, and/or neck that is appropriate for improvement with non-invasive MFU-V treatment.
- Skin condition not advanced enough to require surgical correction.
- Willingness to refrain from elective aesthetic procedures involving the face, submentum, or neck for the entire 12-month duration of the study.
- Ability and willingness to comply with all study visits, procedures, and follow-up requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultherapy PrimeUltherapy 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. | Device | Multi-Depth Ultherapy Prime Treatment, Single-Depth Ultherapy Prime Treatment (1.5 mm) |
Primary outcome
Change in Skin Laxity and Wrinkle Severity of the Lower Face and Neck
Time frame: Baseline to 3 months post-treatment
Clinical improvement in skin laxity, lines, and wrinkles of the lower face, submentum, and neck will be assessed by the Principal Investigator using the Global Aesthetic Improvement Scale (GAIS) and standardized 2D/3D photographs. The primary endpoint evaluates whether treatment with Ultherapy Prime results in a measurable improvement in lifting, tightening, and skin smoothness compared with baseline. GAIS scores range from "Very Much Improved" to "Worse," with higher ratings indicating greater aesthetic improvement.
1 secondary outcome
Change in Skin Laxity, Lines, and Wrinkle Severity at 6 and 12 Months
Time frame: Baseline to 6 months, and Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Levine, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultherapy Prime in people with Laxity; Skin, run by The Levine Center for Plastic Surgery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer M Levine, MD (2125179400, info@drjenniferlevine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin Laxity and Wrinkle Severity of the Lower Face and Neck (time frame: Baseline to 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.