Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck

NCT07614997 | Recruiting FDA Device

• 1 other identifier: ULT-LAX-CN002
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to demonstrate superiority of treatment with the Ulthera System compared to untreated control for the improvement of skin laxity of the lower face, submental area and neck and to demonstrate the safety of treatment with the Ulthera System for the improvement of skin laxity of the lower face, submental area and neck.

Conditions

Cutis Laxa

Keywords

Skin laxity

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With at Least "Improved" in Lower Face, Submental and Neck Skin Laxity on Global Aesthetic Improvement Scale as Determined by the Blinded Live Evaluator (eGAIS) at Day 90 Compared to Baseline Photographs

  Blinded live evaluator will use eGAIS to evaluate global aesthetic improvement in the facial appearance of participants. The GAIS is a 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Higher scores indicate a worse outcome.

  Day 90

Secondary Outcomes (3)

• Three Independent, Blinded Raters GAIS (rGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs

  Day 90

• Treating Investigator's GAIS (iGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs

  Day 90

• Participant's GAIS (pGAIS) Scores in Lower Face, Submental Skin and Neck Laxity at Day 90 Compared to Baseline Photographs

  Day 90

Study Arms (2)

Treatment With Ulthera System

EXPERIMENTAL

Participants randomized to receive a single treatment with Ulthera system to lower face, submentum and neck on Day 1.

Device: Ulthera System

Control/Delayed treatment With Ulthera System

OTHER

Participants will remain untreated until Day 90 and then receive a single treatment with Ulthera system to lower face, submentum and neck.

Device: Ulthera System

Interventions

Ulthera System DEVICE

Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.

Control/Delayed treatment With Ulthera System; Treatment With Ulthera System

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate lower face, submental and/or neck laxity, that is amenable to improvement with non-invasive intervention and not severe enough for surgical intervention.
• Willing to abstain from all other aesthetic treatments on ANY part of the face, submentum or neck, including but not limited to injectable fillers, implants, neurotoxin, skin peels, laser treatments, surgical treatments, etc. for the clinical investigation's duration.
• Willing and able to refrain from chronic use of aspirin, ibuprofen, naproxen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) for 10 to 14 days post-treatment.
• Has an adequate understanding of the Chinese language.
• Willing and able to comply with protocol requirements.

You may not qualify if:

• Scarring in area(s) to be treated.
• Any active implants.
• Any metallic implants in area(s) to be treated.
• Any open wounds or lesions, including active herpes simplex, in the area(s) to be treated.
• Presence of an active systemic or local skin disease, including active, cystic, or severe inflammatory acne in the area(s) to be treated.
• History of keloid formation or hypertrophic scarring.
• History of the following cosmetic treatments in area(s) to be treated:
• Skin-tightening procedure,
• Injectable crosslinked hyaluronic acid (HA)/collagen temporary dermal fillers of the lower face, submentum or neck within the past 12 months.
• Injectable non-crosslinked HA dermal fillers of the lower face, submentum or neck within the past 6 months.
• Injectable semi-permanent/permanent facial fillers
• Neurotoxin treatment of the lower face, submentum or neck within the past 6 months.
• Liposuction of the lower face, submentum or neck within the last 12 months.
• Fat grafting of the lower face, submentum or neck within the last 12 months.
• Deoxycholic acid within the last 12 months; and/or

Sponsors & Collaborators

• Merz North America, Inc.: lead
• Ulthera, Inc: collaborator

Study Sites (7)

Merz Investigative Site

Beijing, Beijing Municipality, 100034, China

RECRUITING

Merz Investigative Site

Beijing, Beijing Municipality, 100730, China

RECRUITING

Merz Investigative Site

Guangzhou, Guangdong, 510317, China

RECRUITING

Merz Investigative Site

Nanjing, Jiangsu, 210003, China

RECRUITING

Merz Investigative Site

Xi'an, Shaanxi, 710004, China

RECRUITING

Merz Investigative Site

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Merz Investigative Site

Shanghai, Shanghai Municipality, 200443, China

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

Study Officials

• Merz Medical Expert

  Merz North America, Inc.

  STUDY DIRECTOR

Central Study Contacts

Public Disclosure Manager Merz Aesthetics

CONTACT

+1 984-301-3095; Aesthetic.Trials@merz.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)