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

NCT07229430 | Recruiting DMC FDA Device

• 1 other identifier: CS-483
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 5

Brief 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 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.

Conditions

Skin Laxity (Submental and Neck); Facial Skin Laxity; Submental Tissue Laxity

Keywords

ULTRAFORMER MPT PLUS; High-Intensity Focused Ultrasound; HIFU; Submental Lifting; Skin Laxity; Non-surgical Lift; Aesthetic Device; Classys; Non-Inferiority Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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.).

  90 Days Post-Treatment

Secondary Outcomes (6)

• Submental Area Lift [Time Frame: 60 Days Post-Treatment]

  60 Days Post-Treatment

• Submental Area Lift [Time Frame: 90 Days Post-Treatment]

  90 Days Post-Treatment

• Change in Overall Lifting of Treated Tissue on Submental and Neck Regions [Time Frame: 60 and 90 Days Post-Treatment]

  60 and 90 Days Post-Treatment

• Global Aesthetic Improvement Scale (GAIS) Results [Time Frame: 60 and 90 Days Post-Treatment]

  60 and 90 Days Post-Treatment

• Subject Satisfaction Questionnaire[Time Frame: 60 and 90 Days Post-Treatment]

  60 and 90 Days Post-Treatment

Study Arms (2)

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.

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.

Device: Ulthera System

Interventions

ULTRAFORMER MPT PLUS DEVICE

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.

ULTRAFORMER MPT PLUS Group

Ulthera System DEVICE

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.

Ulthera Comparator Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• CLASSYS Inc.: lead

Study Sites (5)

Dermatology

Los Angeles, California, 90004, United States

RECRUITING

Dermatology

Charlotte, North Carolina, 28405, United States

RECRUITING

Dermatology

Wilmington, North Carolina, 28405, United States

RECRUITING

Dermatology

Nashville, Tennessee, 37203, United States

RECRUITING

Dermatology

Spokane, Washington, 99204, United States

RECRUITING

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Megan Kim

CONTACT

+82-10-3723-4829; jihyekim@classys.com

James Lim

CONTACT

h.lim@classys.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is evaluator-blinded. Participants and outcomes assessors will remain blinded to treatment allocation, while treatment providers will be unblinded to operate the assigned device.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: October 16, 2025
• Primary Completion (Estimated): November 26, 2026
• Study Completion (Estimated): November 26, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)