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

Not Applicable

Completed

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

• Registration Number: NCT04795622
• Lead Sponsor: Merz North America, Inc.

Brief 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.

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 Timeline

• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-12
• Study Start: 2021-03-16
• Primary Completion: 2022-01-18
• Study Completion: 2022-05-17
• Results First Submitted: 2023-01-18
• Results First Submitted QC: 2023-02-13
• Results First Posted: 2023-02-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Ulthera System	Ultherapy treatment	-
Delayed-treatment Ulthera System	Untreated-control / delayed-treatment	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Improvement in Lower Face and Submental Skin Laxity at Day 90	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.

Secondary Outcome Measures

Name	Time	Method
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	Baseline up to Day 90	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).
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	Day 90	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.
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	Day 90	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.
Displacement of Skin in the Submentum at Day 90	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).
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)

Trial Locations

Locations (5)

Peking University First Hospital, Merz Investigational Site #0860003; 🇨🇳 Beijing, China

Shanghai 9th Hospital, Plastic Surgery, Merz Investigational Site #0860015; 🇨🇳 Shanghai, China

Air Force General Hospital, Merz Investigational Site #0860002; 🇨🇳 Beijing, China

Huashan Hospital Shanghai, Merz Investigational Site #0860004; 🇨🇳 Shanghai, China

Beijing Hospital, Plastic Surgery, Merz Investigational Site #0860029; 🇨🇳 Beijing, China