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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cutis Laxa
• Intervention / Treatment: Device: Ulthera System

• Study Type: Interventional
• Enrollment (Estimated): 218
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Public Disclosure Manager Merz Aesthetics; Phone Number: +1 984-301-3095; Email: Aesthetic.Trials@merz.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
  • Chemical peeling or dermabrasion treatments within the past 12 months.
  • Cryolipolysis
• Had prior surgery in the lower-facial area and/or neck/submentum or has a permanent implant or graft in the lower-facial area that could interfere with effectiveness assessments.
• Has undergone oral surgery in the past 30 days.
• Participants who have used isotretinoin or other retinoid medications within 6 months prior to enrollment or have applied topical retinoid-containing medications on the face or neck area within 2 weeks prior to enrollment or planning such treatments during the study period.
• Marked facial asymmetry, deep dermal scarring, or thick sebaceous skin in the full face.
• Severe solar elastosis.
• Facial nerve palsy or history of facial nerve palsy.
• Tattoos in the area(s) to be treated (excluding microblading eyebrow).
• Current smoker or history of smoking in the last 12 months.
• Current daily user of any nicotine-containing products
• Is a female of childbearing potential1 and not using medically effective birth control 2 or is pregnant, lactating, or planning to become pregnant during the clinical investigation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment With Ulthera System; Participants randomized to receive a single treatment with Ulthera system to lower face, submentum and neck on Day 1.	Device: Ulthera System; Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.
Other: Control/Delayed treatment With Ulthera System; 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; Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Three Independent, Blinded Raters GAIS (rGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs	Three independent, blinded raters will use rGAIS 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
Treating Investigator's GAIS (iGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs	Treating investigators will use the iGAIS to assess overall aesthetic improvement of the lower face, submentum, and neck. 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. This outcome measure is prespecified for the Treatment Group only.	Day 90
Participant's GAIS (pGAIS) Scores in Lower Face, Submental Skin and Neck Laxity at Day 90 Compared to Baseline Photographs	Participants will self-report using the pGAIS to assess overall aesthetic improvement of the lower face, submentum, and neck. The pGAIS 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. This outcome measure is prespecified for the Treatment Group only.	Day 90

Collaborators and Investigators

• Sponsor: Merz North America, Inc.
• Collaborators: Ulthera, Inc
• Investigators: Study Director: Merz Medical Expert, Merz North America, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Skin laxity
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases; Skin Diseases, Genetic; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Cutis Laxa
• Other Study ID Numbers: ULT-LAX-CN002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No