High-Intensity Focused Ultrasound for Double Chin and Turkey Neck

Recruiting at 4 trial locations

Overseen By Megan Jihye Kim

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CLASSYS Inc.

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Facelift, Pacemaker, Keloid, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 61

Duration: 1 day

273 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ultrasound device, the ULTRAFORMER MPT PLUS, to evaluate its ability to tighten and lift sagging skin under the chin and neck compared to the already approved Ulthera System. It involves two groups: one using the new device and another using the existing one. The goal is to determine if the new device effectively reduces skin laxity and wrinkles. Individuals with mild to moderate sagging skin in these areas who have maintained a stable weight for at least six months might be suitable for this trial. Participants should not have had recent aesthetic treatments or surgeries in the neck or chin area. As an unphased trial, this study allows participants to contribute to innovative research in aesthetic treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on blood thinners (medications that prevent blood clots), you may need to stop them for the procedure. It's best to discuss your medications with the study team.

What prior data suggests that this device is safe for lifting and tightening submental and neck tissue?

Research has shown that the ULTRAFORMER MPT PLUS, a device using focused ultrasound, is generally safe for tightening loose skin under the chin and neck. Studies have found that people usually tolerate this treatment well. Common side effects, such as mild redness and swelling, typically resolve within two weeks. Importantly, previous research has found no serious side effects. Overall, this ultrasound treatment is considered a safe and effective option for non-surgical skin tightening and lifting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ULTRAFORMER MPT PLUS because it uses high-intensity focused ultrasound (HIFU) energy to target and tighten the skin under the chin and neck, a key area for many seeking non-surgical cosmetic solutions. Unlike traditional treatments like surgical lifts or injectables, ULTRAFORMER MPT PLUS stimulates neocollagenesis, encouraging the body to produce new collagen for a natural-looking lift and firmness over time. This approach offers a non-invasive alternative with the potential for less downtime and a more gradual, subtle enhancement, appealing to those cautious about more invasive procedures.

What evidence suggests that the ULTRAFORMER MPT PLUS device is effective for lifting and tightening submental and neck tissue?

Research has shown that the ULTRAFORMER MPT PLUS device, which participants in this trial may receive, can lift and tighten skin without surgery. Studies have found it works particularly well on the neck, with improvements of up to 3.55 mm. Skin elasticity, or how firm the skin feels, also improved within four weeks of treatment. After three months, patients noticed firmer cheeks and necks, along with fewer wrinkles. A review of several studies found that about 77% of people experienced positive results within 90 days. Overall, evidence supports that this treatment can effectively improve loose skin and reduce wrinkles in the neck and chin areas. Meanwhile, the Ulthera System, another treatment option in this trial, serves as the reference comparator and also uses focused ultrasound energy to lift and tighten submental and neck skin. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with loose skin under the chin or neck, often referred to as a double chin or turkey neck. Participants should be looking for non-surgical options to tighten this area. Specific eligibility criteria are not provided, but typically participants must be in good health and meet certain age and condition severity requirements.

Inclusion Criteria

I agree not to have any cosmetic procedures in the treatment area during the study.

Subjects able to understand and sign informed consent and comply with all study visits and procedures

I am a woman who can have children and agree to use birth control during the study.

Exclusion Criteria

I haven't had any cosmetic treatments like lasers or fillers in the last 6 months.

History of keloid formation or abnormal wound healing

I have an active skin issue like an infection or severe acne near the treatment area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the ULTRAFORMER MPT PLUS or the comparator device treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Multiple visits (in-person) at 60, 90, and 180 days post-treatment

Safety Review

Data from initial safety stages reviewed by DSMB before progression to pivotal phase

Ongoing during initial stages

What Are the Treatments Tested in This Trial?

Interventions

• Ulthera System
• ULTRAFORMER MPT PLUS

Trial Overview The trial is testing the ULTRAFORMER MPT PLUS against the Ulthera System, both high-intensity focused ultrasound devices designed to lift and tighten skin beneath the chin and on the neck. The goal is to show that ULTRAFORMER MPT PLUS works just as well as its comparator in improving appearance without surgery.

How Is the Trial Designed?

Group I: ULTRAFORMER MPT PLUS Group Experimental Treatment 1 Intervention

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.

Group II: Ulthera Comparator Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

CLASSYS Inc.

Lead Sponsor

Trials

3

Recruited

500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11452089/

Three-dimensional Analysis of Lifting Effects after High ... The results showed significant lifting effects across seven areas, with highest lift observed in the neck region (3.55 mm) and the most ...

2. ultraformer.com ultraformer.com/ultraformer-study-achieve-effective-non-surgical-face-lifting/

Achieve Effective Non-surgical Face Lifting - ultraformer The Ultraformer study showed effective non-surgical face lifting, tightening, and whitening using HIFU technology, treating multiple skin ...

3. ultraformer.com ultraformer.com/ultraformer-study-tightening-effects-of-hifu-on-skin/

ULTRAFORMER Study: Tightening Effects of HIFU on Skin Skin elasticity measured via cutometer was significantly improved 4 weeks after treatment at all treated sites (P<0.05>). All patients scored ...

4. labxclinic.com labxclinic.com/en/expected-results-from-ultraformer-mpt-reviews-and-real-case-studies/

Expected results from Ultraformer MPT, real case study After 1 month: Skin starts to tighten, wrinkles around the eyes are slightly reduced. After 3 months: Cheeks and neck are clearly firmer, wrinkles around the ...

5. researchgate.net researchgate.net/publication/367197928_A_Systematic_Review_of_the_Efficacy_of_Microfocused_Ultrasound_for_Facial_Skin_Tightening

(PDF) A Systematic Review of the Efficacy of Microfocused ... Ling and Zhao's meta-analysis of facial tightening and rejuvenation studies showed a response rate of 77% (95% CI: 58%, 96%) at 90 days and 69% ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07229430

Safety and Effectiveness Evaluation of the High-intensity ... Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue. ClinicalTrials.

7. researchgate.net researchgate.net/publication/391681134_Efficacy_and_Safety_of_High-Intensity_Focused_Ultrasound_HIFU_on_Reduction_of_Unwanted_Submental_Fat_in_Asian_Patients

Efficacy and Safety of High-Intensity Focused Ultrasound ... No significant side effects or adverse events were reported. Expected common side effects were noted but resolved within 2 weeks. The HIFU ...

8. mdpi.com mdpi.com/2076-3417/15/9/4958

Complications and Risks of High-Intensity Focused ... The findings confirm that HIFU is generally safe and effective, with most complications being mild and transient, such as temporary erythema, swelling, and ...