Improvement in Skin Laxity of the Lower Face and SubmentumNCT04795622
Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum
A study testing Ultherapy treatment in people with Improvement in Skin Laxity of the Lower Face and Submentum, run by Merz North America, Inc. at 5 sites in China.
Trial summary
1. Demonstrate superiority of treatment with the Ulthera DeepSEE System compared to untreated control for the improvement of skin laxity of the lower face and submental area. 2. Demonstrate the safety of treatment with the Ulthera DeepSEE System for the improvement of skin laxity of the lower face and submental area. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Improvement in Skin Laxity of the Lower Face and Submentum
- What is being tested?
- Ultherapy treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 5 sitesChina
- Study dates
- 16 Mar 2021to 17 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 and/or submental laxity that is amenable to improvement with non-invasive intervention and is not severe enough for surgical intervention;
Who cannot join
- Scarring in area(s) to be treated;
- Any active implants (e.g., pacemakers or defibrillators) in the area(s) to be treated;
- Any metallic implants in area(s) to be treated;
- Any open wounds or lesions in the area(s) to be treated;
- Body mass index (BMI) less than 19 or greater than 30; or
- Gain or loss of ≥ 2 BMI units within the previous 90 days or has the intention to gain or lose ≥ 2 BMI units during the course of the trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Peking University First Hospital, Merz Investigational Site #0860003
Beijing, 100034
Air Force General Hospital, Merz Investigational Site #0860002
Beijing, 100142
Beijing Hospital, Plastic Surgery, Merz Investigational Site #0860029
Beijing, 100730
Shanghai 9th Hospital, Plastic Surgery, Merz Investigational Site #0860015
Shanghai, 200011
Huashan Hospital Shanghai, Merz Investigational Site #0860004
Shanghai, 200040
About this study
- Demonstrate superiority of treatment with the Ulthera DeepSEE System compared to untreated control for the improvement of skin laxity of the lower face and submental area.
- Demonstrate the safety of treatment with the Ulthera DeepSEE System for the improvement of skin laxity of the lower face and submental area.
Read the detailed description
Subjects in the study received a single treatment with Ulthera DeepSEE system on the midface, lower face, submental (under the chin) and upper neck area using 3 DeepSEE (DS) transducers (DS 10-1.5, DS 7-3.0, DS 7-4.5) at either Day 1 or Day 90. Subjects treated at Day 1 were followed for 180 days after treatment and subjects treated at Day 90 were followed for 90 days after treatment.
- Being tested
- Ultherapy treatment, Untreated-control / delayed-treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultherapy treatmentDevice
Focused ultrasound energy delivered below the surface of the skin
Untreated-control / delayed-treatmentDevice
Untreated-control, followed by Ultherapy treatment (focused ultrasound energy delivered below the surface of the skin)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Ulthera System | Experimental | Not described Receives: Device: Ultherapy treatment |
| Delayed-treatment Ulthera System | Other | Not described Receives: Device: Untreated-control / delayed-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Improvement in Lower Face and Submental Skin Laxity at Day 90
Lower face and submental skin laxity were determined by three blinded evaluators after comparing Day 90 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 90 photographs as "improved" compared to baseline.
Measured: Day 90
Secondary outcomes (5)
Displacement of Skin in the Submentum at Day 90
Displacement of skin (in millimeters [mm]) in the submentum was determined by three-dimensional (3D) quantitative photographic analysis by comparing Day 90 photographs with baseline photographs. X-axis (lateral), Y-axis (vertical), and Z-axis (anterior to posterior) direction components were provided for both sides of the face combined (that is, overall).
Measured: Day 90
Percentage of Subjects With Any Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) at Day 90 as Assessed by the Treating Investigator in the Treatment Group
iGAIS ratings (-3 to +3 scores; lower scores meant worse outcome) used baseline photographs for comparison. Improvement was defined as a rating of +1, +2, or +3 on the iGAIS.
Measured: Day 90
Percentage of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) at Day 90 as Assessed by the Subjects in the Treatment Group
sGAIS ratings (-3 to +3 scores; lower scores meant worse outcome) used baseline photographs for comparison. Improvement was defined as a rating of +1, +2, or +3 on the sGAIS.
Measured: Day 90
Change From Baseline in FACE-Q Satisfaction With Lower Face and Jawline Score (Rasch-transformed) at Day 90, as Assessed by Subjects in Treatment Group
The subject assessed satisfaction using the Face-Q Satisfaction with Lower Face and Jawline module (1 [very dissatisfied] to 4 [very satisfied] scores; Rasch transformed score 0-100; higher scores meant better outcome).
Measured: Baseline up to Day 90
Number of Subjects With at Least One Treatment-related Treatment-emergent Adverse Events (TEAEs)
Measured: From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start16 Mar 2021
- Primary completion18 Jan 2022
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Improvement in Skin Laxity of the Lower Face and SubmentumStudies 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
- 201 participants (actual)
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
- NCT04795622
- Sponsor's protocol ID
- M960101056
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2021
- Last updated
- 23 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum
- ClinicalTrials.gov ID
- NCT04795622
- Acronym / sponsor ID
- M960101056
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ulthera, Inc
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Posted 15 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Demonstrate superiority of treatment with the Ulthera DeepSEE System compared to untreated control for the improvement of skin laxity of the lower face and submental area.
- Demonstrate the safety of treatment with the Ulthera DeepSEE System for the improvement of skin laxity of the lower face and submental area.
Detailed description
Subjects in the study received a single treatment with Ulthera DeepSEE system on the midface, lower face, submental (under the chin) and upper neck area using 3 DeepSEE (DS) transducers (DS 10-1.5, DS 7-3.0, DS 7-4.5) at either Day 1 or Day 90. Subjects treated at Day 1 were followed for 180 days after treatment and subjects treated at Day 90 were followed for 90 days after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Ulthera System | Experimental | Device: Ultherapy treatment |
| Delayed-treatment Ulthera System | Other | Device: Untreated-control / delayed-treatment |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild to moderate lower face and/or submental laxity that is amenable to improvement with non-invasive intervention and is not severe enough for surgical intervention;
Key exclusion criteria (6 listed)
- Scarring in area(s) to be treated;
- Any active implants (e.g., pacemakers or defibrillators) in the area(s) to be treated;
- Any metallic implants in area(s) to be treated;
- Any open wounds or lesions in the area(s) to be treated;
- Body mass index (BMI) less than 19 or greater than 30; or
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 |
|---|---|---|
| Ultherapy treatmentFocused ultrasound energy delivered below the surface of the skin | Device | Treatment Ulthera System |
| Untreated-control / delayed-treatmentUntreated-control, followed by Ultherapy treatment (focused ultrasound energy delivered below the surface of the skin) | Device | Delayed-treatment Ulthera System |
Primary outcome
Percentage of Subjects With Improvement in Lower Face and Submental Skin Laxity at Day 90
Time frame: Day 90
Lower face and submental skin laxity were determined by three blinded evaluators after comparing Day 90 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 90 photographs as "improved" compared to baseline.
5 secondary outcomes
Displacement of Skin in the Submentum at Day 90
Time frame: Day 90
Percentage of Subjects With Any Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) at Day 90 as Assessed by the Treating Investigator in the Treatment Group
Time frame: Day 90
Percentage of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) at Day 90 as Assessed by the Subjects in the Treatment Group
Time frame: Day 90
Change From Baseline in FACE-Q Satisfaction With Lower Face and Jawline Score (Rasch-transformed) at Day 90, as Assessed by Subjects in Treatment Group
Time frame: Baseline up to Day 90
Number of Subjects With at Least One Treatment-related Treatment-emergent Adverse Events (TEAEs)
Time frame: From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Merz Medical Expert study director
Merz North America, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultherapy treatment in people with Improvement in Skin Laxity of the Lower Face and Submentum, run by Merz North America, Inc. at 5 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 15 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Improvement in Lower Face and Submental Skin Laxity at Day 90 (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 23 Mar 2023.