Skin Laxity (Submental and Neck)NCT07229430
Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue
A study testing ULTRAFORMER MPT PLUS and Ulthera System in people with Skin Laxity (Submental and Neck) and Facial Skin Laxity, run by CLASSYS Inc. at 5 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity (Submental and Neck), Facial Skin Laxity, Submental Tissue Laxity
- What is being tested?
- ULTRAFORMER MPT PLUS and Ulthera System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Oct 2025to 26 Nov 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 30 to 65 years, inclusive, at the time of informed consent.
- Subjects presenting with mild to moderate submental and/or neck skin laxity, as determined by the investigator.
- Subjects in good general health with stable body weight (±5%) for at least 6 months prior to screening.
- Subjects willing to avoid other aesthetic or dermatologic procedures (surgical or non-surgical) to the treatment area during the study period.
- Subjects able to understand and sign informed consent and comply with all study visits and procedures.
- Female subjects of child-bearing potential who agree to use reliable contraception throughout study participation.
Who cannot join
- Prior facelift, neck lift, liposuction, or contouring surgery involving the lower face, submental, or neck areas.
- 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.
- Presence of any implanted electronic medical device, such as a pacemaker, defibrillator, or neurostimulator.
- Active skin infection, wound, cystic acne, inflammation, or severe scarring within or near the treatment area.
- History of keloid formation or abnormal wound healing.
- Known bleeding disorder, or use of anticoagulant or antiplatelet medications that cannot be safely discontinued for the procedure.
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- Pregnant or breastfeeding women.
- Subjects with a known sensitivity or contraindication to ultrasound-based procedures.
- Any medical or psychiatric condition that, in the investigator's judgment, could interfere with study participation, safety, or data integrity.
- Participation in another investigational study within 30 days prior to screening.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
James Lim contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Dermatology
Charlotte, North Carolina, 28405
M, MD, +1 (704) 375-6766
- Recruiting
Dermatology
Los Angeles, California, 90004
J, MD, +1 (323) 464-8046
- Recruiting
Dermatology
Nashville, Tennessee, 37203
B, MD, +1 (615) 329-1110
- Recruiting
Dermatology
Spokane, Washington, 99204
W, MD, +1-509-343-3710
- Recruiting
Dermatology
Wilmington, North Carolina, 28405
G, MD, +1 (910) 256-4350
About this study
Official title: 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
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.
Approximately 273 subjects will be enrolled at multiple investigational sites across the United States.
Read more
Participants 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.
The 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.
Read the detailed description
This prospective, multicenter, randomized, evaluator-blinded, parallel-controlled, non-inferiority clinical investigation is conducted under an FDA Investigational Device Exemption (IDE #G250041) to evaluate the safety and effectiveness of the ULTRAFORMER MPT PLUS (Class II high-intensity focused ultrasound system) for aesthetic improvement of submental and neck tissue laxity.
A total of approximately 273 subjects aged 30-65 years with mild-to-moderate skin laxity in the submental and neck areas will be enrolled across up to 5 U.S. investigational sites. Subjects will be randomized 1:1 to receive either ULTRAFORMER MPT PLUS or the comparator device (ULTHERA® System, Merz Aesthetics, USA).
Primary endpoints include blinded investigator-assessed improvement using the validated Facial Laxity Grading Scale and safety outcomes based on the incidence and severity of device-related adverse events. Secondary endpoints include participant-reported improvement scores, digital image analysis, and durability of effect at 8-week and 12-week follow-ups.
The study consists of two sequential safety stages (Stage 1A and 1B; 20 subjects total) followed by the pivotal Stage 2 phase (approximately 253 subjects). Data from the safety stages will be reviewed by an independent Data Safety Monitoring Board (DSMB) prior to progression to Stage 2.
All treatments will be performed by trained investigators according to the protocol-defined parameters. Subjects will be evaluated at baseline, post-treatment, and during follow-up visits up to 6 months. The final statistical analysis will assess non-inferiority of ULTRAFORMER MPT PLUS to the predicate device with respect to the primary efficacy endpoint and confirm overall safety.
- Being tested
- ULTRAFORMER MPT PLUS, Ulthera System
- Keywords
- ULTRAFORMER MPT PLUS, High-Intensity Focused Ultrasound, HIFU, Submental Lifting, Skin Laxity, Non-surgical Lift, Aesthetic Device, Classys, Non-Inferiority Clinical Trial
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULTRAFORMER MPT PLUSDevice
ULTRAFORMER MPT PLUS (Classys Inc., Seoul, Korea) is a high-intensity focused ultrasound (HIFU) system that delivers focused energy at multiple depths to induce neocollagenesis and tissue contraction for non-surgical lifting and tightening of submental and neck tissue. The device includes both Default and MP modes and is under investigation under FDA IDE G250041.
Ulthera SystemDevice
The Ulthera System (Merz Aesthetics, USA) is an FDA-cleared high-intensity focused ultrasound (HIFU) device indicated for non-invasive lifting and tightening of lax tissue in the submental and neck areas. It serves as the active comparator for this non-inferiority clinical study.
| Study group | Role | What they receive |
|---|---|---|
| ULTRAFORMER MPT PLUS Group | Experimental | ULTRAFORMER MPT PLUS (Classys Inc., Seoul, Korea) delivers high-intensity focused ultrasound (HIFU) energy to the subdermal tissue to induce neocollagenesis and tissue contraction for non-surgical skin tightening and lifting. Receives: Device: ULTRAFORMER MPT PLUS |
| Ulthera Comparator Group | Active comparator | The Ulthera® System (Merz Aesthetics, USA) uses focused ultrasound energy to lift and tighten submental and neck skin and serves as the reference comparator in this non-inferiority clinical trial. Receives: Device: Ulthera System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Submental Area Lift [Time Frame: 90 Days Post-Treatment]
The primary endpoint of the study is the Submental Area Lift "Success" evaluated at 90 days post-treatment.
A "Success" is defined as a reduction in the measured submental area of ≥ 20 mm² compared with baseline. Both left and right lateral 2D images will be derived from 3D photographs and analyzed by certified technicians using the Submental Lift Application (Canfield Scientific Inc.).
Measured: 90 Days Post-Treatment
Secondary outcomes (6)
Submental Area Lift [Time Frame: 60 Days Post-Treatment]
Submental Area Lift ≥ 20 mm² vs baseline.
Measured: 60 Days Post-Treatment
Submental Area Lift [Time Frame: 90 Days Post-Treatment]
Submental Area Lift ≥ 20 mm² vs baseline.
Measured: 90 Days Post-Treatment
Change in Overall Lifting of Treated Tissue on Submental and Neck Regions [Time Frame: 60 and 90 Days Post-Treatment]
Percentage of patients assessed to have improvement in skin laxity (lifted skin) by ≥ 2 of 3 independent blinded evaluators comparing pre-, 60-, and 90-day post-treatment images. Images will be prepared and randomized for review per Canfield SOPs (FDA K121700).
Measured: 60 and 90 Days Post-Treatment
Global Aesthetic Improvement Scale (GAIS) Results [Time Frame: 60 and 90 Days Post-Treatment]
Overall aesthetic improvement rated on a 5-point scale (1 = Very Much Improved to 5 = Worse) by the investigator comparing pre- and post-treatment photographs. Assessed by PI or delegated qualified staff at each visit.
Measured: 60 and 90 Days Post-Treatment
Subject Satisfaction Questionnaire[Time Frame: 60 and 90 Days Post-Treatment]
5-point Likert scale (1 = Very Satisfied to 5 = Very Dissatisfied). "Satisfied" = Very Satisfied or Satisfied.
Completed at each follow-up visit.
Measured: 60 and 90 Days Post-Treatment
Visual Analog Scale (VAS) - Pain Score[Time Frame:Immediately Post-Treatment]
Subject-reported pain (0 = No pain, 10 = Worst pain possible) recorded immediately after treatment completion.
Pain management at investigator's discretion; if applicable, documented as AE.
Measured: Immediately Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start16 Oct 2025
- Primary completion26 Nov 2026 (estimated)
- Study completion26 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Laxity (Submental and Neck)Studies 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
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either ULTRAFORMER MPT PLUS treatment or the comparator device (Ulthera® System). Each subject receives a single assigned treatment without crossover.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 273 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CLASSYS Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229430
- Sponsor's protocol ID
- CS-483
- Status last verified
- Apr 2026
- First submitted
- 13 Nov 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07229430
- Acronym / sponsor ID
- CS-483
- Keywords
- ULTRAFORMER MPT PLUS, High-Intensity Focused Ultrasound, HIFU, Submental Lifting, Skin Laxity, Non-surgical Lift, Aesthetic Device, Classys
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 273 participants (estimated)
- Lead sponsor
- CLASSYS Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 26 Nov 2026 (estimated)
- Study completion
- 26 Nov 2026 (estimated)
- First posted
- 17 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.
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.
Approximately 273 subjects will be enrolled at multiple investigational sites across the United States.
Participants 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.
The 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.
Detailed description
This prospective, multicenter, randomized, evaluator-blinded, parallel-controlled, non-inferiority clinical investigation is conducted under an FDA Investigational Device Exemption (IDE #G250041) to evaluate the safety and effectiveness of the ULTRAFORMER MPT PLUS (Class II high-intensity focused ultrasound system) for aesthetic improvement of submental and neck tissue laxity.
A total of approximately 273 subjects aged 30-65 years with mild-to-moderate skin laxity in the submental and neck areas will be enrolled across up to 5 U.S. investigational sites. Subjects will be randomized 1:1 to receive either ULTRAFORMER MPT PLUS or the comparator device (ULTHERA® System, Merz Aesthetics, USA).
Primary endpoints include blinded investigator-assessed improvement using the validated Facial Laxity Grading Scale and safety outcomes based on the incidence and severity of device-related adverse events. Secondary endpoints include participant-reported improvement scores, digital image analysis, and durability of effect at 8-week and 12-week follow-ups.
The study consists of two sequential safety stages (Stage 1A and 1B; 20 subjects total) followed by the pivotal Stage 2 phase (approximately 253 subjects). Data from the safety stages will be reviewed by an independent Data Safety Monitoring Board (DSMB) prior to progression to Stage 2.
All treatments will be performed by trained investigators according to the protocol-defined parameters. Subjects will be evaluated at baseline, post-treatment, and during follow-up visits up to 6 months. The final statistical analysis will assess non-inferiority of ULTRAFORMER MPT PLUS to the predicate device with respect to the primary efficacy endpoint and confirm overall safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either ULTRAFORMER MPT PLUS treatment or the comparator device (Ulthera® System). Each subject receives a single assigned treatment without crossover.
| Arm | Type | Receives |
|---|---|---|
| ULTRAFORMER MPT PLUS Group | Experimental | Device: ULTRAFORMER MPT PLUSULTRAFORMER MPT PLUS (Classys Inc., Seoul, Korea) delivers high-intensity focused ultrasound (HIFU) energy to the subdermal tissue to induce neocollagenesis and tissue contraction for non-surgical skin tightening and lifting. |
| Ulthera Comparator Group | Active comparator | Device: Ulthera SystemThe Ulthera® System (Merz Aesthetics, USA) uses focused ultrasound energy to lift and tighten submental and neck skin and serves as the reference comparator in this non-inferiority clinical trial. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects aged 30 to 65 years, inclusive, at the time of informed consent.
- Subjects presenting with mild to moderate submental and/or neck skin laxity, as determined by the investigator.
- Subjects in good general health with stable body weight (±5%) for at least 6 months prior to screening.
- Subjects willing to avoid other aesthetic or dermatologic procedures (surgical or non-surgical) to the treatment area during the study period.
- Subjects able to understand and sign informed consent and comply with all study visits and procedures.
Key exclusion criteria (10 listed)
- Prior facelift, neck lift, liposuction, or contouring surgery involving the lower face, submental, or neck areas.
- 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.
- Presence of any implanted electronic medical device, such as a pacemaker, defibrillator, or neurostimulator.
- Active skin infection, wound, cystic acne, inflammation, or severe scarring within or near the treatment area.
- History of keloid formation or abnormal wound healing.
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 |
|---|---|---|
| ULTRAFORMER MPT PLUSULTRAFORMER MPT PLUS (Classys Inc., Seoul, Korea) is a high-intensity focused ultrasound (HIFU) system that delivers focused energy at multiple depths to induce neocollagenesis and tissue contraction for non-surgical lifting and tightening of submental and neck tissue. The device includes both Default and MP modes and is under investigation under FDA IDE G250041. | Device | ULTRAFORMER MPT PLUS Group |
| Ulthera SystemThe Ulthera System (Merz Aesthetics, USA) is an FDA-cleared high-intensity focused ultrasound (HIFU) device indicated for non-invasive lifting and tightening of lax tissue in the submental and neck areas. It serves as the active comparator for this non-inferiority clinical study. | Device | Ulthera Comparator Group |
Primary outcome
Submental Area Lift [Time Frame: 90 Days Post-Treatment]
Time frame: 90 Days Post-Treatment
The primary endpoint of the study is the Submental Area Lift "Success" evaluated at 90 days post-treatment. A "Success" is defined as a reduction in the measured submental area of ≥ 20 mm² compared with baseline. Both left and right lateral 2D images will be derived from 3D photographs and analyzed by certified technicians using the Submental Lift Application (Canfield Scientific Inc.).
6 secondary outcomes
Submental Area Lift [Time Frame: 60 Days Post-Treatment]
Time frame: 60 Days Post-Treatment
Submental Area Lift [Time Frame: 90 Days Post-Treatment]
Time frame: 90 Days Post-Treatment
Change in Overall Lifting of Treated Tissue on Submental and Neck Regions [Time Frame: 60 and 90 Days Post-Treatment]
Time frame: 60 and 90 Days Post-Treatment
Global Aesthetic Improvement Scale (GAIS) Results [Time Frame: 60 and 90 Days Post-Treatment]
Time frame: 60 and 90 Days Post-Treatment
Subject Satisfaction Questionnaire[Time Frame: 60 and 90 Days Post-Treatment]
Time frame: 60 and 90 Days Post-Treatment
Visual Analog Scale (VAS) - Pain Score[Time Frame:Immediately Post-Treatment]
Time frame: Immediately Post-Treatment
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 20 Apr 2026.
- 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.
James Lim contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ULTRAFORMER MPT PLUS and Ulthera System in people with Skin Laxity (Submental and Neck) and Facial Skin Laxity, run by CLASSYS Inc. at 5 sites 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 6 inclusion and 10 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 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Megan Kim (+82-10-3723-4829, jihyekim@classys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Submental Area Lift [Time Frame: 90 Days Post-Treatment] (time frame: 90 Days 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 20 Apr 2026.