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Evaluation of the Ulthera® System and Efficacy Correlation to Morphological Differences

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ClinicalTrials.gov Identifier: NCT03599349
Recruitment Status : Completed
First Posted : July 25, 2018
Results First Posted : June 11, 2019
Last Update Posted : June 11, 2019
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 and Neck Skin Laxity
Intervention Device: Microfocused ultrasound w/ visualization
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Microfocused Ultrasound w/ Visualization
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 20
Treated 20
Completed 19
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Microfocused Ultrasound w/ Visualization
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
50.7  (3.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
17
  85.0%
Male
3
  15.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
2
  10.0%
Not Hispanic or Latino
18
  90.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 20 participants
Asian
1
   5.0%
Black/African Amercican
0
   0.0%
White
19
  95.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
1.Primary Outcome
Title Determine if There is a Correlation Between D90 Quantitative Efficacy Results of the Eyebrow and Lower Face Region With Where the TCPs Produced During Ultherapy Treatment Make Contact With Anatomical Layers of the Skin and Underlying Tissues.
Hide Description 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
Time Frame Day 90 post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Microfocused Ultrasound w/ Visualization
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Comparison of CGAIS Ratings to Average SMAS and Average Dermal Thickness of the Treated Areas to Determine if There is or is Not a Correlation.
Hide Description 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.
Time Frame Day 90 and 180 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
CGAIS data was not collected. A correlation analysis could therefore not be performed.
Arm/Group Title Microfocused Ultrasound w/ Visualization
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 90 and 180 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
SGAIS data was not collected. A correlation analysis could therefore not be performed.
Arm/Group Title Microfocused Ultrasound w/ Visualization
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title 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
Hide Description

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)
Time Frame Day 90 and 180 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Microfocused Ultrasound w/ Visualization
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Correlation coefficient
Dermal thickness to overall aesthetic improvement 0.2791
SMAS thickness to overall aesthetic improvement -1.0156
5.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 90 and 180 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Microfocused Ultrasound w/ Visualization
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Correlation coefficient
Dermis Depth to patient satisfaction -2.1597
SMAS thickness to patient satisfaction 0.0216
6.Secondary Outcome
Title The Depth of Frontal Region Tissue Layers Will be Compared to the Quantitative Measurements of Lift in the Eyebrow Region to Determine if There is or is Not a Correlation.
Hide Description 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
Time Frame Day 90 and 180 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Microfocused Ultrasound w/ Visualization
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title The Depth of the Temple Region Tissue Layers Will be Compared to the Quantitative Measurement of Lift the Eyebrow Region to Determine if There is or is Not a Correlation.
Hide Description 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.
Time Frame Day 90 and 180 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Microfocused Ultrasound w/ Visualization
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title The Depth of Cheek Tissue Layers Will be Compared to the Quantitative Measurement of Lift in the Lower Face Regions to Determine if There is or is Not a Correlation.
Hide Description 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.
Time Frame Day 90 and 180 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Microfocused Ultrasound w/ Visualization
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title The Depth of Submental Tissue Layers Will be Compared to the Quantitative Measurement of Lift in the Lower Face Regions to Determine if There is or is Not a Correlation
Hide Description 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.
Time Frame Day 90 and 180 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Microfocused Ultrasound w/ Visualization
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline up to 180 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Microfocused Ultrasound w/ Visualization
Hide Arm/Group Description 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.
All-Cause Mortality
Microfocused Ultrasound w/ Visualization
Affected / at Risk (%)
Total   0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Microfocused Ultrasound w/ Visualization
Affected / at Risk (%) # Events
Total   1/20 (5.00%)    
Gastrointestinal disorders   
Pancreatitis Acute  1  1/20 (5.00%)  1
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Microfocused Ultrasound w/ Visualization
Affected / at Risk (%) # Events
Total   3/20 (15.00%)    
Injury, poisoning and procedural complications   
Tibia fracture  1  1/20 (5.00%)  1
Ligament rupture  1  1/20 (5.00%)  1
Surgical and medical procedures   
Bunion operation  1  1/20 (5.00%)  1
1
Term from vocabulary, MedDRA 21.1
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
Layout table for Results Point of Contact information
Name/Title: Public Disclosure Manager
Organization: Merz Pharmaceuticals GmbH
Phone: +49 69 1503 865
EMail: clinicaltrials@merz.com
Layout table for additonal information
Responsible Party: Merz North America, Inc. ( Ulthera, Inc )
ClinicalTrials.gov Identifier: NCT03599349     History of Changes
Other Study ID Numbers: ULT-145
First Submitted: July 4, 2018
First Posted: July 25, 2018
Results First Submitted: May 17, 2019
Results First Posted: June 11, 2019
Last Update Posted: June 11, 2019