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

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.

Study Overview

• Status: Completed
• Conditions: Improvement in Skin Laxity of the Lower Face and Submentum
• Intervention / Treatment: Device: Ultherapy treatment; Device: Untreated-control / delayed-treatment

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 Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Ulthera System	Device: Ultherapy treatment; Focused ultrasound energy delivered below the surface of the skin
Other: Delayed-treatment Ulthera System	Device: Untreated-control / delayed-treatment; Untreated-control, followed by Ultherapy treatment (focused ultrasound energy delivered below the surface of the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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).	Baseline up to Day 90
Number of Subjects With at Least One Treatment-related Treatment-emergent Adverse Events (TEAEs)		From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180)

Collaborators and Investigators

• Sponsor: Merz North America, Inc.
• Collaborators: Ulthera, Inc

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Actual): January 18, 2022
• Study Completion (Actual): May 17, 2022

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: M960101056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes