Trial Outcomes & Findings for Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215) (NCT NCT03545412)
NCT ID: NCT03545412
Last Updated: 2018-12-12
Results Overview
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.
COMPLETED
NA
25 participants
Baseline, Day 90
2018-12-12
Participant Flow
The study was conducted at 1 site in Taiwan.
A total of 25 participants were screened, enrolled and treated in the study.
Participant milestones
| Measure |
Ultherapy Treatment
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.
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|---|---|
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Overall Study
STARTED
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25
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Overall Study
COMPLETED
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25
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)
Baseline characteristics by cohort
| Measure |
Ultherapy Treatment
n=25 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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25 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
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Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Caucasian
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0 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
African American/ Black
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0 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Hispanic/ Latino
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0 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Asian
|
25 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Native Amer. Indian/ Alaskan Native
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0 Participants
n=5 Participants
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Region of Enrollment
Taiwan
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25 participants
n=5 Participants
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Body Mass Index (BMI)
|
22.0 kilogram per square meter (kg/m^2)
n=5 Participants
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Fitzpatrick Skin Type
Skin Type I
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0 Participants
n=5 Participants
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Fitzpatrick Skin Type
Skin Type II
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0 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type III
|
3 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type IV
|
22 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type V
|
0 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type VI
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 90Population: 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.
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.
Outcome measures
| Measure |
Ultherapy Treatment
n=13 Participants
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.
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|---|---|
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Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90
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8 Participants
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PRIMARY outcome
Timeframe: Baseline, Day 90Population: 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.
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.
Outcome measures
| Measure |
Ultherapy Treatment
n=24 Participants
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.
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|---|---|
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Number of Participants With Lift in Brow Region at Day 90
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12 Participants
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SECONDARY outcome
Timeframe: Baseline, Day 90Population: All participants who were treated with Ultherapy were included for the assessment.
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.
Outcome measures
| Measure |
Ultherapy Treatment
n=25 Participants
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.
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|---|---|
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Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90
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21 Participants
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SECONDARY outcome
Timeframe: Baseline, Day 90Population: All participants who were treated with Ultherapy were included for the assessment.
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.
Outcome measures
| Measure |
Ultherapy Treatment
n=25 Participants
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.
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|---|---|
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Number of Participants With Overall Aesthetic Improvement as Assessed by the Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90
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21 Participants
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SECONDARY outcome
Timeframe: Day 90Population: All participants who were treated with Ultherapy were included for the assessment.
Participants completed a PSQ at the 90-day visit. The PSQ has 5 satisfaction categories ranging from 'very dissatisfied' to 'very satisfied'.
Outcome measures
| Measure |
Ultherapy Treatment
n=25 Participants
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.
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|---|---|
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Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90
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21 Participants
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SECONDARY outcome
Timeframe: Baseline, Day 180Population: All participants who were treated with Ultherapy were included for the assessment.
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.
Outcome measures
| Measure |
Ultherapy Treatment
n=25 Participants
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.
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|---|---|
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Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180
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22 Participants
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SECONDARY outcome
Timeframe: Baseline, Day 180Population: All participants who were treated with Ultherapy were included for the assessment.
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.
Outcome measures
| Measure |
Ultherapy Treatment
n=25 Participants
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.
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|---|---|
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Number of Participants With Overall Aesthetic Improvement as Assessed by the SGAIS at Day 180
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20 Participants
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Adverse Events
Ultherapy Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ultherapy Treatment
n=25 participants at risk
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.
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|---|---|
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Injury, poisoning and procedural complications
Contusion
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68.0%
17/25 • Baseline up to Day 180
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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General disorders
Application site edema
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12.0%
3/25 • Baseline up to Day 180
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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General disorders
Application site tenderness
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12.0%
3/25 • Baseline up to Day 180
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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Immune system disorders
Hypersensitivity
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4.0%
1/25 • Baseline up to Day 180
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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General disorders
Application site burn
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4.0%
1/25 • Baseline up to Day 180
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place