Can sound waves tighten your neck? new trial aims to find out
NCT ID NCT07614997
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if the Ulthera System, a non-invasive ultrasound device, can safely improve sagging skin on the lower face, under the chin, and neck. About 218 adults with mild to moderate skin laxity will receive treatment or no treatment, and results will be measured at 90 days. Participants must avoid other facial aesthetic treatments during the study.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 218 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Merz Investigative Site
RECRUITINGBeijing, Beijing Municipality, 100034, China
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Merz Investigative Site
RECRUITINGBeijing, Beijing Municipality, 100730, China
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Merz Investigative Site
RECRUITINGGuangzhou, Guangdong, 510317, China
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Merz Investigative Site
RECRUITINGNanjing, Jiangsu, 210003, China
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Merz Investigative Site
RECRUITINGXi'an, Shaanxi, 710004, China
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Merz Investigative Site
RECRUITINGShanghai, Shanghai Municipality, 200040, China
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Merz Investigative Site
RECRUITINGShanghai, Shanghai Municipality, 200443, China