Evaluate if there is a correlation between efficacy results and where the Thermal Coagulation Points (TCPs) produced during a treatment with the Ulthera System make contact with anatomical layers of the skin and underlying tissues.
This is a prospective, single-site, non-randomized study designed to evaluate if there is a correlation between efficacy results and where the Thermal Coagulation Points (TCPs), produced during treatment with the Ulthera System, make contact with the anatomical layers of skin and underlying tissues. The study consists of one Ultherapy treatment administered at two depths using DeepSEE transducers on the full-face and neck area. Ultrasound images will be captured at the beginning, middle and end of each treatment section during treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Clinical Testing of Beverly Hills
Beverly Hills, California, United States
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.
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
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.
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
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
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
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
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 90 and 180 post-treatment
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
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
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.
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
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.
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
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.
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
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
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