Cutis LaxaNCT07614997
Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck
A study testing Ulthera System in people with Cutis Laxa, run by Merz North America, Inc. at 7 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutis Laxa
- What is being tested?
- Ulthera System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 7 sitesChina
- Study dates
- 15 Jun 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 27Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Merz Investigative Site
Beijing, Beijing Municipality, 100034
- Recruiting
Merz Investigative Site
Beijing, Beijing Municipality, 100730
- Recruiting
Merz Investigative Site
Guangzhou, Guangdong, 510317
- Recruiting
Merz Investigative Site
Nanjing, Jiangsu, 210003
- Recruiting
Merz Investigative Site
Shanghai, Shanghai Municipality, 200040
- Recruiting
Merz Investigative Site
Shanghai, Shanghai Municipality, 200443
- Recruiting
Merz Investigative Site
Xi'an, Shaanxi, 710004
About this study
Official title: 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.
- Conditions
- Cutis Laxa
- Being tested
- Ulthera System
- Keywords
- Skin laxity
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulthera SystemDevice
Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.
| Study group | Role | What they receive |
|---|---|---|
| Treatment With Ulthera System | Experimental | Participants randomized to receive a single treatment with Ulthera system to lower face, submentum and neck on Day 1. Receives: 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. Receives: Device: Ulthera System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start15 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutis LaxaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ulthera, Inc
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614997
- Sponsor's protocol ID
- ULT-LAX-CN002
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Safety of the Ulthera® System for Treating Skin Laxity in the Lower Face, Submentum and Neck
- ClinicalTrials.gov ID
- NCT07614997
- Acronym / sponsor ID
- ULT-LAX-CN002
- Conditions
- Cutis Laxa
- Keywords
- Skin laxity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ulthera, Inc
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment With Ulthera System | Experimental | Device: Ulthera SystemParticipants randomized to receive a single treatment with Ulthera system to lower face, submentum and neck on Day 1. |
| Control/Delayed treatment With Ulthera System | Other | Device: Ulthera SystemParticipants will remain untreated until Day 90 and then receive a single treatment with Ulthera system to lower face, submentum and neck. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulthera SystemParticipants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers. | Device | Control/Delayed treatment With Ulthera System, Treatment With Ulthera System |
Primary outcome
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
Time frame: Day 90
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.
3 secondary outcomes
Three Independent, Blinded Raters GAIS (rGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs
Time frame: Day 90
Treating Investigator's GAIS (iGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs
Time frame: Day 90
Participant's GAIS (pGAIS) Scores in Lower Face, Submental Skin and Neck Laxity at Day 90 Compared to Baseline Photographs
Time frame: Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Merz Medical Expert study director
Merz North America, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulthera System in people with Cutis Laxa, run by Merz North America, Inc. at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Public Disclosure Manager Merz Aesthetics (+1 984-301-3095, Aesthetic.Trials@merz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.