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Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215) (ULT-215)

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ClinicalTrials.gov Identifier: NCT03545412
Recruitment Status : Completed
First Posted : June 4, 2018
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Facial Skin Laxity
Intervention Device: Microfocused ultrasound with visualization
Enrollment 25
Recruitment Details The study was conducted at 1 site in Taiwan.
Pre-assignment Details A total of 25 participants were screened, enrolled and treated in the study.
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths.
Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
Baseline analysis population included all participants that were enrolled and treated with Ultherapy.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
23
  92.0%
Male
2
   8.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Caucasian
0
   0.0%
African American/ Black
0
   0.0%
Hispanic/ Latino
0
   0.0%
Asian
25
 100.0%
Native Amer. Indian/ Alaskan Native
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 25 participants
25
Body Mass Index (BMI)  
Mean (Full Range)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 25 participants
22.0
(18.6 to 26.0)
Fitzpatrick Skin Type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Skin Type I
0
   0.0%
Skin Type II
0
   0.0%
Skin Type III
3
  12.0%
Skin Type IV
22
  88.0%
Skin Type V
0
   0.0%
Skin Type VI
0
   0.0%
[1]
Measure Description: Skin type I = white; very fair, red or blonde hair blue eyes; freckles; always burns, never tans, skin type II = white, fair, red or blond hair; blue, hazel or green eyes; usually burns, tans with difficulty, skin type III = cream white; fair with any eye or hair color (common); sometimes mild burn, gradually tans, skin type IV = brown; typical Mediterranean Caucasian skin; rarely burns, tans with ease, skin type V = dark brown; mid-eastern skin types; very rarely burns, tans easily, and skin type VI = black; never burns, tans very easily
1.Primary Outcome
Title Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90
Hide Description Lift improvement as measured by quantitative analysis was considered greater than or equal to (>=) 20.0 square millimeter (mm^2) of the submental area Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points on the neck. Area was calculated in between each of the 5 points and then sum of the five calculations was the total area of the region of interest.
Time Frame Baseline, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled and treated with Ultherapy. Only participants categorized as good candidates for photographs were included in the analysis. Good candidates for photographs was defined as those participants who had sufficient distance between the menton and neck, and enough lower face volume to allow for accurate measurements.
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description:
Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths.
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
8
  61.5%
2.Primary Outcome
Title Number of Participants With Lift in Brow Region at Day 90
Hide Description Lift improvement as measured by quantitative analysis was considered minimum 0.5 millimeter (mm) Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points along the natural outline of each participant’s brow. Brow height was calculated using the sum and average of the five calculations in each brow area.
Time Frame Baseline, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were treated with Ultherapy were included for the assessment. The analysis included all participants who had the measurement available for brows. One participant excluded due to inability to measure brow.
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description:
Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths.
Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
12
  50.0%
3.Secondary Outcome
Title Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90
Hide Description Overall aesthetic improvement was assessed by the principal investigator using global aesthetic improvement scale (GAIS). At 90 days post-treatment, each principal investigator completed a GAIS, known as physician global aesthetic improvement scale (PGAIS) .The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.
Time Frame Baseline, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were treated with Ultherapy were included for the assessment.
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description:
Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths.
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
21
  84.0%
4.Secondary Outcome
Title Number of Participants With Overall Aesthetic Improvement as Assessed by the Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90
Hide Description Overall aesthetic improvement was assessed by participants using global aesthetic improvement scale (GAIS). At 90 days post-treatment, each participant completed a GAIS, known as SGAIS.The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.
Time Frame Baseline, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were treated with Ultherapy were included for the assessment.
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description:
Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths.
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
21
  84.0%
5.Secondary Outcome
Title Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90
Hide Description Participants completed a PSQ at the 90-day visit. The PSQ has 5 satisfaction categories ranging from 'very dissatisfied' to 'very satisfied'.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were treated with Ultherapy were included for the assessment.
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description:
Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths.
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
21
  84.0%
6.Secondary Outcome
Title Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180
Hide Description Overall aesthetic improvement was assessed by the principal investigator using the GAIS. At 180 days post-treatment, each principal investigator completed a GAIS, known as PGAIS .The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.
Time Frame Baseline, Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were treated with Ultherapy were included for the assessment.
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description:
Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths.
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
22
  88.0%
7.Secondary Outcome
Title Number of Participants With Overall Aesthetic Improvement as Assessed by the SGAIS at Day 180
Hide Description Overall aesthetic improvement was assessed by participants using GAIS. At 180 days post-treatment, each participant completed a GAIS, known as SGAIS. The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.
Time Frame Baseline, Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were treated with Ultherapy were included for the assessment.
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description:
Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths.
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
20
  80.0%
Time Frame Baseline up to Day 180
Adverse Event Reporting Description The investigator asked the participant for adverse events (AEs) systematically at each visit.
 
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths.
All-Cause Mortality
Ultherapy Treatment
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ultherapy Treatment
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ultherapy Treatment
Affected / at Risk (%)
Total   19/25 (76.00%) 
General disorders   
Application site edema   3/25 (12.00%) 
Application site tenderness   3/25 (12.00%) 
Application site burn   1/25 (4.00%) 
Immune system disorders   
Hypersensitivity   1/25 (4.00%) 
Injury, poisoning and procedural complications   
Contusion   17/25 (68.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Public Disclosure Manager
Organization: Merz Pharmaceuticals GmbH
Phone: +49 69 1503 1
Responsible Party: Merz North America, Inc. ( Ulthera, Inc )
ClinicalTrials.gov Identifier: NCT03545412     History of Changes
Other Study ID Numbers: ULT-215
First Submitted: May 22, 2018
First Posted: June 4, 2018
Results First Submitted: November 20, 2018
Results First Posted: December 12, 2018
Last Update Posted: December 12, 2018