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

Merz North America, Inc.201 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

201

Conditions

Improvement in Skin Laxity of the Lower Face and Submentum

Interventions

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)

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

Peking University First Hospital, Merz Investigational Site #0860003

Beijing, China

Air Force General Hospital, Merz Investigational Site #0860002

Beijing, China

Beijing Hospital, Plastic Surgery, Merz Investigational Site #0860029

Beijing, China

Shanghai 9th Hospital, Plastic Surgery, Merz Investigational Site #0860015

Shanghai, China

Outcomes

Primary Outcomes

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

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

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

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

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).

Data from ClinicalTrials.gov

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