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

Improvement in Skin Laxity of the Lower Face and Submentum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04795622
• Other study ID #: M960101056
• Status: Completed
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: May 17, 2022

Study information

• Verified date: March 2023
• Source: Merz North America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: May 17, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutis Laxa
• Improvement in Skin Laxity of the Lower Face and Submentum

Intervention

Device:
• Ultherapy treatment
Focused ultrasound energy delivered below the surface of the skin
• Untreated-control / delayed-treatment
Untreated-control, followed by Ultherapy treatment (focused ultrasound energy delivered below the surface of the skin)

Locations

Country	Name	City	State
China	Air Force General Hospital, Merz Investigational Site #0860002	Beijing
China	Beijing Hospital, Plastic Surgery, Merz Investigational Site #0860029	Beijing
China	Peking University First Hospital, Merz Investigational Site #0860003	Beijing
China	Huashan Hospital Shanghai, Merz Investigational Site #0860004	Shanghai
China	Shanghai 9th Hospital, Plastic Surgery, Merz Investigational Site #0860015	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Merz North America, Inc.	Ulthera, Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)