Trial Outcomes & Findings for Evaluation of the Ulthera® System and Efficacy Correlation to Morphological Differences (NCT NCT03599349)
NCT ID: NCT03599349
Last Updated: 2019-06-11
Results Overview
TCP = Thermal Coagulation Points. The average Superficial Musculo-Aponeurotic System (SMAS) depth in the eyebrow and lower face regions (cheeks, submental and submandibular) will be compared to quantitative measurement of lift in the eyebrow and submental/neck lift at day 90 post-treatment
COMPLETED
NA
20 participants
Day 90 post treatment
2019-06-11
Participant Flow
Participant milestones
| Measure |
Microfocused Ultrasound w/ Visualization
Subject were treated on the full-face and neck area treatment using a standard 800 line treatment with set energy levels (0.90 joules for the 4-4.5mm transducer, 0.30 joules for the 7-3.0mm/7-3.0N transducers and 0.75 joules for the 7-4.5mm transducer). Ultrasound images were captured at the beginning, middle, and end of each treatment section during treatment.
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Overall Study
STARTED
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20
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Overall Study
Treated
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20
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Overall Study
COMPLETED
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19
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Microfocused Ultrasound w/ Visualization
Subject were treated on the full-face and neck area treatment using a standard 800 line treatment with set energy levels (0.90 joules for the 4-4.5mm transducer, 0.30 joules for the 7-3.0mm/7-3.0N transducers and 0.75 joules for the 7-4.5mm transducer). Ultrasound images were captured at the beginning, middle, and end of each treatment section during treatment.
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Evaluation of the Ulthera® System and Efficacy Correlation to Morphological Differences
Baseline characteristics by cohort
| Measure |
Microfocused Ultrasound w/ Visualization
n=20 Participants
Subject were treated on the full-face and neck area treatment using a standard 800 line treatment with set energy levels (0.90 joules for the 4-4.5mm transducer, 0.30 joules for the 7-3.0mm/7-3.0N transducers and 0.75 joules for the 7-4.5mm transducer). Ultrasound images were captured at the beginning, middle, and end of each treatment section during treatment.
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Age, Continuous
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50.7 years
STANDARD_DEVIATION 3.7 • n=99 Participants
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Sex: Female, Male
Female
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17 Participants
n=99 Participants
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Sex: Female, Male
Male
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3 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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18 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Race/Ethnicity, Customized
Race · Asian
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1 Participants
n=99 Participants
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Race/Ethnicity, Customized
Race · Black/African Amercican
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0 Participants
n=99 Participants
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Race/Ethnicity, Customized
Race · White
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19 Participants
n=99 Participants
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Region of Enrollment
United States
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20 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Day 90 post treatmentPopulation: Quantitative assessment of lift was not performed due to lack of quality of pre- and post-treatment images and inconsistencies in head positioning of the subjects. A correlation analysis could therefore not be performed.
TCP = Thermal Coagulation Points. The average Superficial Musculo-Aponeurotic System (SMAS) depth in the eyebrow and lower face regions (cheeks, submental and submandibular) will be compared to quantitative measurement of lift in the eyebrow and submental/neck lift at day 90 post-treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 90 and 180 post-treatmentPopulation: CGAIS data was not collected. A correlation analysis could therefore not be performed.
The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a CGAIS assessing overall aesthetic improvement at day 90 and 180 post-treatment. The CGAIS will be compared to average SMAS and average dermal thickness of the treated areas to determine if there is or is not a correlation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 90 and 180 post-treatmentPopulation: SGAIS data was not collected. A correlation analysis could therefore not be performed.
The subject will complete a SGAIS assessing overall aesthetic improvement at day 90 and 180 post-treatment which will be compared to average SMAS and average dermal thickness of the treated areas to determine if there is or is not a correlation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 90 and 180 post-treatmentPopulation: A total of 20 subjects were enrolled and treated. Of these, data on this secondary outcome was available for 20 subjects at day 90 and for 19 subjects at day 180. Correlation was analyzed for the overall duration of the study (including both D90 and D180 data).
Degree of overall aesthetic improvement determined by a masked, qualitative assessment of photographs at 90 and 180 days post-treatment compared to baseline, based on level of clearance/improvement. The percent improvement will be compared to the average SMAS and average dermal thickness of the treated areas to determine if there is or is not a correlation. Level of improvement scale: 1. 0 = 0% Improvement (None) 2. 1 = \< 25% Improvement (Mild) 3. 2 = 26 to 50% Improvement (Moderate) 4. 3 = 51 to 75% Improvement (Significant) 5. 4 = 76 to 100% Improvement (Very Significant)
Outcome measures
| Measure |
Microfocused Ultrasound w/ Visualization
n=20 Participants
Subject were treated on the full-face and neck area treatment using a standard 800 line treatment with set energy levels (0.90 joules for the 4-4.5mm transducer, 0.30 joules for the 7-3.0mm/7-3.0N transducers and 0.75 joules for the 7-4.5mm transducer). Ultrasound images were captured at the beginning, middle, and end of each treatment section during treatment.
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Qualitative Assessment of Overall Aesthetic Improvement Will be Compared to the Average SMAS and Average Dermal Thickness of the Treated Areas to Determine if There is or is Not a Correlation
Dermal thickness to overall aesthetic improvement
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0.2791 Correlation coefficient
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Qualitative Assessment of Overall Aesthetic Improvement Will be Compared to the Average SMAS and Average Dermal Thickness of the Treated Areas to Determine if There is or is Not a Correlation
SMAS thickness to overall aesthetic improvement
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-1.0156 Correlation coefficient
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SECONDARY outcome
Timeframe: Day 90 and 180 post-treatmentPopulation: A total of 20 subjects were enrolled and treated. Of these, data on this secondary outcome was available for 20 subjects at day 90 and for 19 subjects at day 180. Correlation was analyzed for the overall duration of the study (including both D90 and D180 data).
The subject will complete a patient satisfaction questionnaire at the 90 and 180 day follow-up visits which will be compared to average SMAS and average dermal thickness of the treated areas to determine if there is or is not a correlation.
Outcome measures
| Measure |
Microfocused Ultrasound w/ Visualization
n=20 Participants
Subject were treated on the full-face and neck area treatment using a standard 800 line treatment with set energy levels (0.90 joules for the 4-4.5mm transducer, 0.30 joules for the 7-3.0mm/7-3.0N transducers and 0.75 joules for the 7-4.5mm transducer). Ultrasound images were captured at the beginning, middle, and end of each treatment section during treatment.
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|---|---|
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The Subject Will Complete a Patient Satisfaction Questionnaire at the 90 and 180 Day Follow-up Visits Which Will be Compared to Average SMAS and Average Dermal Thickness of the Treated Areas to Determine if There is or is Not a Correlation
Dermis Depth to patient satisfaction
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-2.1597 Correlation coefficient
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The Subject Will Complete a Patient Satisfaction Questionnaire at the 90 and 180 Day Follow-up Visits Which Will be Compared to Average SMAS and Average Dermal Thickness of the Treated Areas to Determine if There is or is Not a Correlation
SMAS thickness to patient satisfaction
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0.0216 Correlation coefficient
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SECONDARY outcome
Timeframe: Day 90 and 180 post-treatmentPopulation: Quantitative assessment of lift was not performed due to lack of consistency and usability of pre- and post-treatment images and inconsistencies in head positioning of the subjects. A correlation analysis could therefore not be performed.
The depth of the following frontal region tissue layers; dermis, subq adipose/fibrous septae, suprafrontalis fascia, frontalis muscle and subfrontalis fascia will be compared to the quantitative measurement of lift in the eyebrow region to determine if there is or is not a correlation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 90 and 180 post-treatmentPopulation: Quantitative assessment of lift was not performed due to lack of consistency and usability of pre- and post-treatment images and inconsistencies in head positioning of the subjects. A correlation analysis could therefore not be performed.
The depth of the following temple region tissue layers; dermis, subq adipose/fibrous septae, SMAS and temporalis muscle will be compared to the quantitative measurements of lift in the eyebrow region to determine if there is or is not a correlation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 90 and 180 post-treatmentPopulation: Quantitative assessment of lift was not performed due to lack of consistency and usability of pre- and post-treatment images and inconsistencies in head positioning of the subjects. A correlation analysis could therefore not be performed.
The depth of the following cheek tissue layers; dermis, subq adipose/fibrous septae, and SMAS will be compared to the quantitative measurement of lift in the lower face regions to determine if there is or is not a correlation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 90 and 180 post-treatmentPopulation: Quantitative assessment of lift was not performed. Lack of consistency and usability of pre- and post-treatment images and inconsistencies in head positioning of the subjects. A correlation analysis could therefore not be performed.
The depth of the following submental tissue layers; dermis, subq adipose/fibrous septae, supraplatysmal fascia, platysma and subplatysmal fascia will be compared to the quantitative measurement of lift in the lower face regions to determine if there is or is not a correlation.
Outcome measures
Outcome data not reported
Adverse Events
Microfocused Ultrasound w/ Visualization
Serious adverse events
| Measure |
Microfocused Ultrasound w/ Visualization
n=20 participants at risk
Subject were treated on the full-face and neck area treatment using a standard 800 line treatment with set energy levels (0.90 joules for the 4-4.5mm transducer, 0.30 joules for the 7-3.0mm/7-3.0N transducers and 0.75 joules for the 7-4.5mm transducer). Ultrasound images were captured at the beginning, middle, and end of each treatment section during treatment.
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Gastrointestinal disorders
Pancreatitis Acute
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5.0%
1/20 • Number of events 1 • Baseline up to 180 days
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Other adverse events
| Measure |
Microfocused Ultrasound w/ Visualization
n=20 participants at risk
Subject were treated on the full-face and neck area treatment using a standard 800 line treatment with set energy levels (0.90 joules for the 4-4.5mm transducer, 0.30 joules for the 7-3.0mm/7-3.0N transducers and 0.75 joules for the 7-4.5mm transducer). Ultrasound images were captured at the beginning, middle, and end of each treatment section during treatment.
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Injury, poisoning and procedural complications
Tibia fracture
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5.0%
1/20 • Number of events 1 • Baseline up to 180 days
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Injury, poisoning and procedural complications
Ligament rupture
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5.0%
1/20 • Number of events 1 • Baseline up to 180 days
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Surgical and medical procedures
Bunion operation
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5.0%
1/20 • Number of events 1 • Baseline up to 180 days
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place