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

Recruiting now · Not applicable

Conditions studied: Cutis Laxa

In brief

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.

Key facts

Study ID

NCT07614997

Run by

Merz North America, Inc.

People needed

218

Starts

2026-06-15

Expected to finish

2027-03-01

Last updated by the study team

2026-06-17

Who can join

Age: 35 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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
• 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.

Where it is running

• Merz Investigative Site — Beijing, Beijing Municipality, China (enrolling)
• Merz Investigative Site — Beijing, Beijing Municipality, China (enrolling)
• Merz Investigative Site — Guangzhou, Guangdong, China (enrolling)
• Merz Investigative Site — Nanjing, Jiangsu, China (enrolling)
• Merz Investigative Site — Xi'an, Shaanxi, China (enrolling)
• Merz Investigative Site — Shanghai, Shanghai Municipality, China (enrolling)
• Merz Investigative Site — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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