CClinicalTrials.gg
Sign In
CompletedNCT04795622Updated Mar 23, 2023Results posted

Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum

An interventional study of Ultherapy treatment and Untreated-control / delayed-treatment in Improvement in Skin Laxity of the Lower Face and Submentum, sponsored by Merz North America, Inc.. Completed at 5 sites in China. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-23.

Sponsored by Merz North America, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
201
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Improvement in Skin Laxity of the Lower Face and Submentum

Browse trials for

03

In context

Cutis Laxa

147 studies on the registry are indexed under Cutis Laxa; 35 are open to participants now.

This study's enrollment of 201 is above the median of 30 across 129 interventional studies indexed under Cutis Laxa.

Browse Cutis Laxa studies →

Lead sponsor

Merz North America, Inc. is the lead sponsor of 52 studies on the registry; 2 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 18 (95%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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;

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
201 participants (actual)

Study arms

  • Experimental
    Treatment Ulthera System

    Device: Ultherapy treatment

  • Other
    Delayed-treatment Ulthera System

    Device: Untreated-control / delayed-treatment

Interventions

  • DeviceUltherapy treatment

    Focused ultrasound energy delivered below the surface of the skin

  • DeviceUntreated-control / delayed-treatment

    Untreated-control, followed by Ultherapy treatment (focused ultrasound energy delivered below the surface of the skin)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 90

Secondary outcomes

  1. 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).

    Time frame: Day 90

  2. 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.

    Time frame: Day 90

  3. 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.

    Time frame: Day 90

  4. 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).

    Time frame: Baseline up to Day 90

  5. 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)

07

Results

Posted Feb 15, 2023

Participant flow

Subjects were recruited from 5 investigational sites in China.

Participant flow — Overall Study
MilestoneTreatment With Ulthera DeepSEE SystemUntreated Control/Delayed-treatment With Ulthera DeepSEE System
Started101100
Safety evaluation set (ses)9796
Completed8884
Not completed1316
Withdrew: Adverse event10
Withdrew: Withdrawal by subject33
Withdrew: Protocol violation02
Withdrew: Lost to follow-up23
Withdrew: Other78

Outcome measures

PrimaryPercentage 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.

Time frame:
Day 90
Reported as:
Number · percentage of subjects
Percentage of Subjects With Improvement in Lower Face and Submental Skin Laxity at Day 90
percentage of subjectsTreatment With Ulthera DeepSEE SystemUntreated Control/Delayed-treatment With Ulthera DeepSEE System
Percentage of Subjects With Improvement in Lower Face and Submental Skin Laxity at Day 9054.247.0
Statistical analysis
  • Treatment With Ulthera DeepSEE System vs Untreated Control/Delayed-treatment With Ulthera DeepSEE System · Odds ratio (or): 1.3545 · 95% CI 0.7530 to 2.4365
SecondaryDisplacement 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).

Time frame:
Day 90
Reported as:
Mean · millimeter (mm)
Displacement of Skin in the Submentum at Day 90
millimeter (mm)Treatment With Ulthera DeepSEE SystemUntreated Control/Delayed-treatment With Ulthera DeepSEE System
X-axis-0.0229 ± 0.56710.0571 ± 0.5125
Y-axis-0.1693 ± 0.7151-0.1352 ± 0.6336
Z-axis-0.2279 ± 1.1749-0.4086 ± 1.1509
Statistical analysis
  • Treatment With Ulthera DeepSEE System vs Untreated Control/Delayed-treatment With Ulthera DeepSEE System · Point estimate: -0.0856 · 95% CI -0.2395 to 0.0683
  • Treatment With Ulthera DeepSEE System vs Untreated Control/Delayed-treatment With Ulthera DeepSEE System · Point estimate: -0.0330 · 95% CI -0.2268 to 0.1608
  • Treatment With Ulthera DeepSEE System vs Untreated Control/Delayed-treatment With Ulthera DeepSEE System · Point estimate: 0.1791 · 95% CI -0.1551 to 0.5133
SecondaryPercentage 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.

Time frame:
Day 90
Reported as:
Number · percentage of subjects
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
percentage of subjectsTreatment With Ulthera DeepSEE System
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 Group96.8
SecondaryPercentage 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.

Time frame:
Day 90
Reported as:
Number · percentage of subjects
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
percentage of subjectsTreatment With Ulthera DeepSEE System
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 Group94.7
SecondaryChange 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).

Time frame:
Baseline up to Day 90
Reported as:
Mean · score on a scale
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
score on a scaleTreatment With Ulthera DeepSEE System
Change From Baseline in FACE-Q Satisfaction With Lower Face and Jawline Score (Rasch-transformed) at Day 90, as Assessed by Subjects in Treatment Group30.3 ± 23.39
SecondaryNumber 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)
Reported as:
Count of participants · Participants
Number of Subjects With at Least One Treatment-related Treatment-emergent Adverse Events (TEAEs)
ParticipantsTreatment With Ulthera DeepSEE SystemUntreated Control/Delayed-treatment With Ulthera DeepSEE System
Number of Subjects With at Least One Treatment-related Treatment-emergent Adverse Events (TEAEs)3634

Adverse events

Collected over From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment With Ulthera DeepSEE System0/97 (0%)3/97 (3.1%)34/97 (35.1%)
Untreated Control/Delayed-treatment With Ulthera DeepSEE System0/96 (0%)0/96 (0%)32/96 (33.3%)
Most frequent serious events
Most frequent serious events
EventTreatment With Ulthera DeepSEE SystemUntreated Control/Delayed-treatment With Ulthera DeepSEE System
CholelithiasisHepatobiliary disorders1/970/96
Fractured sacrumInjury, poisoning and procedural complications1/970/96
Radius fractureInjury, poisoning and procedural complications1/970/96
Gastric leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/970/96
Most frequent other events
Most frequent other events
EventTreatment With Ulthera DeepSEE SystemUntreated Control/Delayed-treatment With Ulthera DeepSEE System
Application site painGeneral disorders22/9724/96
Application site swellingGeneral disorders16/973/96
Application site vesiclesGeneral disorders9/973/96
UrticariaSkin and subcutaneous tissue disorders8/973/96
Application site discomfortGeneral disorders6/972/96
Application site erythemaGeneral disorders5/974/96

Baseline characteristics

SES included all subjects who were treated.

Age, Continuous
Age, Continuous(years)Treatment With Ulthera DeepSEE SystemUntreated Control/Delayed-treatment With Ulthera DeepSEE SystemTotal
Mean46.8 ± 7.5747.3 ± 7.2447.1 ± 7.39
Sex: Female, Male
Sex: Female, Male(Participants)Treatment With Ulthera DeepSEE SystemUntreated Control/Delayed-treatment With Ulthera DeepSEE SystemTotal
Female9194185
Male628
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Treatment With Ulthera DeepSEE SystemUntreated Control/Delayed-treatment With Ulthera DeepSEE SystemTotal
Asian9796193
08

Study locations

5 sites
  • Peking University First Hospital, Merz Investigational Site #0860003
    Beijing, 100034, China
  • Air Force General Hospital, Merz Investigational Site #0860002
    Beijing, 100142, China
  • Beijing Hospital, Plastic Surgery, Merz Investigational Site #0860029
    Beijing, 100730, China
  • Shanghai 9th Hospital, Plastic Surgery, Merz Investigational Site #0860015
    Shanghai, 200011, China
  • Huashan Hospital Shanghai, Merz Investigational Site #0860004
    Shanghai, 200040, China
09

References and documents

Study documents

  • Study protocol · Jan 16, 2023
  • Statistical analysis plan · Jan 16, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04795622
Lead sponsor
Merz North America, Inc.
Collaborators
Ulthera, Inc
Responsible party
Sponsor
First posted
Mar 12, 2021
Start date
Mar 16, 2021
Primary completion
Jan 18, 2022
Completion
May 17, 2022
Results posted
Feb 15, 2023
Last update
Mar 23, 2023

Study contacts

Merz Medical Expert
study director · Merz North America, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cutis Laxa→

Other studies from this sponsor

Merz North America, Inc.

Start the discussion