Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue

Study Overview
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Brief Summary
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The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment to obtain lift and tightening of the cheek tissue and improve jawline definition and submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a focused manner below the surface of the skin

Detailed Description
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The primary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment to obtain lift and tighten the cheek tissue. The secondary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment for improvement in jawline definition and submental skin laxity at 3 and 6 months compared to baseline based on the consensus of the three masked reviewers.

Official Title
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Evaluation of the Ulthera™ System For Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity

Conditions
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Mild to Moderate Skin Laxity on Cheek, Mild to Moderate Skin Laxity on Upper Neck, Mild to Moderate Subcutaneous Fat on Cheek, Mild to Moderate Subcutaneous Fat on Upper Neck

Intervention / Treatment
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* Device: Ulthera treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 35 to 60 years Subject in good health Desire lift and tightening of cheek tissue, improvement of jawline definition or submental skin laxity Exclusion Criteria: Pregnant or lactating Has an active systemic or local skin disease that may alter wound healing Severe solar elastosis Excessive subcutaneous fat on the cheeks Excessive skin laxity on the lower face and neck Has significant scarring in areas to be treated Has significant open facial wounds or lesions Has severe or cystic acne on the face

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulthera treatment<br> | Device: Ulthera treatment<br>* treatment of cheeks and upper neck area of face<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions. | The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit. | 90D | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Submental and Neck Skin Laxity by Quantitative Analysis | The percentage of participants assessed as having an improvement in tissue lift, i.e., >20mm2 in submental and neck skin laxity, at 90 Days post-treatment compared to baseline based on quantitative analysis. | 90D | 
| Patient Satisfaction Questionnaire | Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated. | 90D |