Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum
Primary Purpose
Improvement in Skin Laxity of the Lower Face and Submentum
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ultherapy treatment
Untreated-control / delayed-treatment
Sponsored by
About this trial
This is an interventional treatment trial for Improvement in Skin Laxity of the Lower Face and Submentum
Eligibility Criteria
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.
Sites / Locations
- Peking University First Hospital, Merz Investigational Site #0860003
- Air Force General Hospital, Merz Investigational Site #0860002
- Beijing Hospital, Plastic Surgery, Merz Investigational Site #0860029
- Shanghai 9th Hospital, Plastic Surgery, Merz Investigational Site #0860015
- Huashan Hospital Shanghai, Merz Investigational Site #0860004
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Treatment Ulthera System
Delayed-treatment Ulthera System
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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.
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).
Number of Subjects With at Least One Treatment-related Treatment-emergent Adverse Events (TEAEs)
Full Information
NCT ID
NCT04795622
First Posted
March 9, 2021
Last Updated
March 21, 2023
Sponsor
Merz North America, Inc.
Collaborators
Ulthera, Inc
1. Study Identification
Unique Protocol Identification Number
NCT04795622
Brief Title
Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum
Official Title
Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
January 18, 2022 (Actual)
Study Completion Date
May 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz North America, Inc.
Collaborators
Ulthera, Inc
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Improvement in Skin Laxity of the Lower Face and Submentum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Ulthera System
Arm Type
Experimental
Arm Title
Delayed-treatment Ulthera System
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Ultherapy treatment
Intervention Description
Focused ultrasound energy delivered below the surface of the skin
Intervention Type
Device
Intervention Name(s)
Untreated-control / delayed-treatment
Intervention Description
Untreated-control, followed by Ultherapy treatment (focused ultrasound energy delivered below the surface of the skin)
Primary Outcome Measure Information:
Title
Percentage of Subjects With Improvement in Lower Face and Submental Skin Laxity at Day 90
Description
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 Outcome Measure Information:
Title
Displacement of Skin in the Submentum at Day 90
Description
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
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merz Medical Expert
Organizational Affiliation
Merz North America, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Peking University First Hospital, Merz Investigational Site #0860003
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Air Force General Hospital, Merz Investigational Site #0860002
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Beijing Hospital, Plastic Surgery, Merz Investigational Site #0860029
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Shanghai 9th Hospital, Plastic Surgery, Merz Investigational Site #0860015
City
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Huashan Hospital Shanghai, Merz Investigational Site #0860004
City
Shanghai
ZIP/Postal Code
200040
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum
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