Trial Outcomes & Findings for Simulines Non-Inferiority Pivotal Study (NCT NCT02736825)
NCT ID: NCT02736825
Last Updated: 2020-02-19
Results Overview
Participant response was defined as \>=20 mm\^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 90-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.
TERMINATED
NA
262 participants
Day 90
2020-02-19
Participant Flow
The study was conducted at 8 sites in the United States.
A total of 262 participants were screened, enrolled, and treated in the study. Of these, 240 participants completed the 180-days evaluation. The study was terminated at 180 days.
Participant milestones
| Measure |
Group A
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 percent \[%\]) at the 4.5 millimeter (mm) and 3.0 mm depths at EL 2, using standard transducers DeepSEE (DS) 4-4.5 at 0.9 joules (J) with pitch of 1.5 mm and 17 thermal coagulation points (TCPs) per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
135
|
|
Overall Study
COMPLETED
|
117
|
123
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
| Measure |
Group A
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 percent \[%\]) at the 4.5 millimeter (mm) and 3.0 mm depths at EL 2, using standard transducers DeepSEE (DS) 4-4.5 at 0.9 joules (J) with pitch of 1.5 mm and 17 thermal coagulation points (TCPs) per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
11
|
|
Overall Study
Early Termination
|
0
|
1
|
Baseline Characteristics
Simulines Non-Inferiority Pivotal Study
Baseline characteristics by cohort
| Measure |
Group A
n=127 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
n=135 Participants
Participants received single comparable treatment with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducer DS 4-4.5 at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0 S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
Total
n=262 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 Years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
52.6 Years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
53.3 Years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/ Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
123 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
127 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
Height
|
65.5 Centimeter (cm)
STANDARD_DEVIATION 3.0 • n=5 Participants
|
65.3 Centimeter (cm)
STANDARD_DEVIATION 3.0 • n=7 Participants
|
65.4 Centimeter (cm)
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Weight
|
145.1 Kilogram (kg)
STANDARD_DEVIATION 23.0 • n=5 Participants
|
142.1 Kilogram (kg)
STANDARD_DEVIATION 22.3 • n=7 Participants
|
143.6 Kilogram (kg)
STANDARD_DEVIATION 22.6 • n=5 Participants
|
|
Body mass index (BMI)
|
23.7 Kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.8 • n=5 Participants
|
23.4 Kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.8 • n=7 Participants
|
23.6 Kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 90Population: The intent-to-treat (ITT) population consisted of all participants in the SES for whom the primary efficacy variable was available.
Participant response was defined as \>=20 mm\^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 90-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.
Outcome measures
| Measure |
Group A
n=126 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
n=132 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
|---|---|---|
|
Number of Participants Who Achieved Greater Than or Equal to (>=) 20 mm^2 Reduction in Submental Area at Day 90
|
64 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Day 180Population: No data was collected because the study was terminated at 180 days.
Participant response was defined as \>=20 mm\^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 180-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 365Population: No data was collected because the study was terminated at 180 days.
Participant response was defined as \>=20 mm\^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 180-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 90Population: The ITT population consisted of all participants in the SES for whom the primary efficacy variable was available.
Improvement was determined by qualitative assessment of photographs by a masked physician.
Outcome measures
| Measure |
Group A
n=126 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
n=132 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
|---|---|---|
|
Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 90
|
67 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Day 180Population: The ITT population consisted of all participants in the SES for whom the primary efficacy variable was available. Participants who were evaluable for this measure at given time period were included.
Improvement was determined by qualitative assessment of photographs by a masked physician.
Outcome measures
| Measure |
Group A
n=117 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
n=123 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
|---|---|---|
|
Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 180
|
55 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Day 365Population: No data was collected because the study was terminated at 180 days.
Improvement was determined by qualitative assessment of photographs by a masked physician.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 90Population: The ITT population consisted of all participants in the SES for whom the primary efficacy variable was available. Participants who were evaluable for this measure at given time period were included.
Additional images were obtained using a 3D digital photo system. QuantifiCare 3D imaging was used to assess the volumetric changes. Four views (Face, UnderRight, UnderLeft, and Neck) were compared for each participant.
Outcome measures
| Measure |
Group A
n=7 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
n=8 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
|---|---|---|
|
Percent Change From Baseline in Volume as Assessed by Quantificare 3 D Imaging System at Day 90
|
-0.8 Percent change
Standard Deviation 4.3
|
-4.1 Percent change
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Day 180Population: The ITT population consisted of all participants in the SES for whom the primary efficacy variable was available.
Additional images were obtained using a 3D digital photo system. QuantifiCare 3D imaging was used to assess the volumetric changes. Four views (Face, UnderRight, UnderLeft, and Neck) were compared for each participant.
Outcome measures
| Measure |
Group A
n=7 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
n=8 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
|---|---|---|
|
Percent Change From Baseline in Volume as Assessed by Quantificare 3D Imaging System at Day 180
|
-4.7 Percent change
Standard Deviation 5.6
|
0.5 Percent change
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Day 365Population: No data was collected because the study was terminated at 180 days.
Additional images were obtained using a 3D digital photo system. QuantifiCare 3D imaging was used to assess the volumetric changes. Four views (Face, UnderRight, UnderLeft, and Neck) were compared for each participant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 90Population: The ITT population consisted of all participants in the SES for whom the primary efficacy variable was available. Participants who were evaluable for this measure at given time period were included.
Participants completed a patient satisfaction questionnaire (PSQ) at the 90-day visit. The PSQ has 5 improvement and satisfaction categories ranging from "worse" to "much improved" and "dissatisfied' to "very satisfied".
Outcome measures
| Measure |
Group A
n=125 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
n=132 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
|---|---|---|
|
Number of Participants With Some Level of Improvement and Satisfaction on Day 90
Much improved
|
23 Participants
|
10 Participants
|
|
Number of Participants With Some Level of Improvement and Satisfaction on Day 90
No change
|
21 Participants
|
36 Participants
|
|
Number of Participants With Some Level of Improvement and Satisfaction on Day 90
Improved
|
30 Participants
|
35 Participants
|
|
Number of Participants With Some Level of Improvement and Satisfaction on Day 90
A little improved
|
48 Participants
|
49 Participants
|
|
Number of Participants With Some Level of Improvement and Satisfaction on Day 90
Worse
|
3 Participants
|
2 Participants
|
|
Number of Participants With Some Level of Improvement and Satisfaction on Day 90
Very satisfied
|
21 Participants
|
10 Participants
|
|
Number of Participants With Some Level of Improvement and Satisfaction on Day 90
Satisfied
|
40 Participants
|
40 Participants
|
|
Number of Participants With Some Level of Improvement and Satisfaction on Day 90
Slightly satisfied
|
28 Participants
|
37 Participants
|
|
Number of Participants With Some Level of Improvement and Satisfaction on Day 90
Neither satisfied or dissatisfied
|
26 Participants
|
37 Participants
|
|
Number of Participants With Some Level of Improvement and Satisfaction on Day 90
Dissatisfied
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: The SES was the subset of all participants who were exposed to study treatment at least once.
Mean treatment time was based on a comparison of average time to complete treatment using each transducer type. The time to complete the study treatment for each group was recorded on the system treatment logs as treatment start time (time treatment started on the Ulthera system) and stop time (time treatment ended on the Ulthera system).
Outcome measures
| Measure |
Group A
n=127 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
n=135 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
|---|---|---|
|
Mean Treatment Times
|
55.6 Minutes
Standard Deviation 15.2
|
33.1 Minutes
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: BaselinePopulation: The SES was the subset of all participants who were exposed to study treatment at least once.
Participant's treatment-related pain scores were obtained using a validated 11-point NRS with 0: no pain; 5: moderate pain; and 10: worst possible pain. Pain scores were obtained following each region treated (submandibular/submental and cheeks) and for each transducer used during treatment. Average pain score was calculated for each arm by adding all the scores of all participants in each arm to obtain the mean NRS score.
Outcome measures
| Measure |
Group A
n=127 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
n=135 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
|---|---|---|
|
Mean Pain Scores to Assess Participant's Treatment Related Comfort Level Based on Numeric Rating Scale (NRS)
4.5 mm Depth
|
5.5 Score on a scale
Standard Deviation 2.1
|
4.6 Score on a scale
Standard Deviation 2.0
|
|
Mean Pain Scores to Assess Participant's Treatment Related Comfort Level Based on Numeric Rating Scale (NRS)
3.0 mm Depth
|
3.1 Score on a scale
Standard Deviation 1.8
|
4.6 Score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Day 90Population: The ITT population consisted of all participants in SES for whom primary efficacy variable was available.
Overall aesthetic improvement was assessed by participants using SGAIS. Each participant completed a SGAIS. The SGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Outcome measures
| Measure |
Group A
n=126 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
n=132 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
|---|---|---|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90
Improved
|
55 Participants
|
73 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90
Very much improved
|
12 Participants
|
3 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90
Much improved
|
18 Participants
|
13 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90
No change
|
37 Participants
|
41 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90
Worse
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 180Population: The ITT population consisted of all participants in SES for whom primary efficacy variable was available. Participants who were evaluable for this measure at given time period were included.
Overall aesthetic improvement was assessed by participants using SGAIS. Each participant completed a SGAIS. The SGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Outcome measures
| Measure |
Group A
n=118 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
n=127 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
|---|---|---|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by SGAIS at Day 180
Much improved
|
18 Participants
|
18 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by SGAIS at Day 180
Improved
|
53 Participants
|
62 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by SGAIS at Day 180
No change
|
36 Participants
|
34 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by SGAIS at Day 180
Worse
|
2 Participants
|
3 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by SGAIS at Day 180
Very much improved
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 365Population: No data was collected because the study was terminated at 180 days.
Overall aesthetic improvement was assessed by participants using SGAIS. Each participant completed a SGAIS. The SGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 90Population: The ITT population consisted of all participants in SES for whom primary efficacy variable was available.
Overall aesthetic improvement was assessed by the clinician using a CGAIS. The CGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Outcome measures
| Measure |
Group A
n=126 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
n=132 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
|---|---|---|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by Clinician Global Aesthetic Improvement Scale (CGAIS) at Day 90
Very much improved
|
10 Participants
|
8 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by Clinician Global Aesthetic Improvement Scale (CGAIS) at Day 90
Much improved
|
33 Participants
|
34 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by Clinician Global Aesthetic Improvement Scale (CGAIS) at Day 90
No change
|
20 Participants
|
24 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by Clinician Global Aesthetic Improvement Scale (CGAIS) at Day 90
Worse
|
0 Participants
|
1 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by Clinician Global Aesthetic Improvement Scale (CGAIS) at Day 90
Improved
|
63 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: Day 180Population: The ITT population consisted of all participants in SES for whom primary efficacy variable was available. Participants who were evaluable for this measure at given time period were included.
Overall aesthetic improvement was assessed by the clinician using a CGAIS. The CGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Outcome measures
| Measure |
Group A
n=118 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
n=127 Participants
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
|---|---|---|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by CGAIS at Day 180
Very much improved
|
5 Participants
|
11 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by CGAIS at Day 180
Much improved
|
32 Participants
|
20 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by CGAIS at Day 180
Improved
|
57 Participants
|
68 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by CGAIS at Day 180
No change
|
24 Participants
|
28 Participants
|
|
Number of Participants With Overall Aesthetic Improvement as Assessed by CGAIS at Day 180
Worse
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 365Population: No data was collected because the study was terminated at 180 days.
Overall aesthetic improvement was assessed by the clinician using a CGAIS. The CGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Outcome measures
Outcome data not reported
Adverse Events
Group A
Group B
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=127 participants at risk
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
|
Group B
n=135 participants at risk
Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
|
|---|---|---|
|
General disorders
Bruising/Ecchymosis
|
3.1%
4/127 • Baseline up to 180 days
The investigator asked the participant for adverse events systematically at each visit.
|
2.2%
3/135 • Baseline up to 180 days
The investigator asked the participant for adverse events systematically at each visit.
|
|
General disorders
Edema
|
9.4%
12/127 • Baseline up to 180 days
The investigator asked the participant for adverse events systematically at each visit.
|
3.0%
4/135 • Baseline up to 180 days
The investigator asked the participant for adverse events systematically at each visit.
|
|
General disorders
Tenderness/Soreness/Pain/ Sensitivity to Touch
|
11.8%
15/127 • Baseline up to 180 days
The investigator asked the participant for adverse events systematically at each visit.
|
6.7%
9/135 • Baseline up to 180 days
The investigator asked the participant for adverse events systematically at each visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
- Publication restrictions are in place
Restriction type: OTHER