Clinical trial Recruiting at 7 sites Interventional Ages 35 to 65

Ulthera System for skin laxity in the lower face, chin, and neck

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

Run by Merz North America, Inc. · NCT07614997 · Data updated 2026-11-12

This study tests whether the Ulthera System can improve loose skin under the chin and on the neck compared with not treating it.

More Cutis Laxa trials

Quick facts

Study typeInterventional
Ages35 Years to 65 Years
SexAll
Enrollment218 (estimated)
SponsorMerz North America, Inc.
Industry-sponsored
Locations7 sites (Beijing, Beijing Municipality and 6 other locations)
StatusRecruiting
StartedJune 15, 2026
Main results expectedDecember 2026
Study endsMarch 2027
Registry record updatedJune 17, 2026
Trial IDNCT07614997 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with mild to moderate non-surgicalable laxity of the lower face, submentum, or neck who commit to avoiding other aesthetic treatments during the study and can comply with protocol requirements.

Probably not a fit

Individuals with severe laxity or conditions requiring surgical intervention, or those not benefiting from non-invasive skin tightening, may not experience improvement.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the safety and effectiveness of the Ulthera System for improving laxity of the lower face, submental area, and neck. Participants receive Ulthera treatments and are compared to an untreated control to determine relative improvements. Eligibility requires mild to moderate laxity suitable for non-surgical intervention, no other aesthetic procedures during the study, and language proficiency in Chinese. Exclusion criteria include active skin issues, implants, wounds, and certain medical conditions that could affect treatment safety. The study is sponsored by Merz North America, with Ulthera as a collaborator, and conducted at-site locations in Beijing and Guangzhou, China.

Why it matters

Potential benefit: If successful, participants may experience improved skin tightness in the lower face, chin, and neck without surgery.

How similar studies have gone: Prior non-surgical skin-tightening approaches have shown varying levels of benefit; this study focuses on a specific device and direct comparison to no treatment.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Merz Investigative Site
    Beijing, Beijing Municipality, China
    Recruiting
  • Merz Investigative Site
    Beijing, Beijing Municipality, China
    Recruiting
  • Merz Investigative Site
    Guangzhou, Guangdong, China
    Recruiting
  • Merz Investigative Site
    Nanjing, Jiangsu, China
    Recruiting
  • Merz Investigative Site
    Xi'an, Shaanxi, China
    Recruiting
  • Merz Investigative Site
    Shanghai, Shanghai Municipality, China
    Recruiting
Show 1 more location
  • Merz Investigative Site
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.