Lifting and Tightening of the Face in Subjects With Skin of Darker Color

Study Overview
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Brief Summary
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This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.

Detailed Description
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The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.

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 in Patients With Fitzpatrick Skin Phototypes 3 Through 6

Conditions
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Facial Skin Laxity

Intervention / Treatment
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* Device: Ulthera® System treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 30 to 65 years. Subject in good health. Subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity. Fitzpatrick skin phototypes of 3 through 6. Provide written informed consent and HIPAA authorization Exclusion Criteria: Pregnant or lactating. Presence of an active systemic or local skin disease that may affect wound healing. Severe solar elastosis. Excessive subcutaneous fat on the cheek. Excessive skin laxity on the lower face and neck. Significant scarring in areas to be treated. Significant open facial wounds or lesions. Severe or cystic acne on the face. Presence of a metal stent or implant in the facial area to be treated.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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® System treatment<br> | Device: Ulthera® System treatment<br>* Ulthera® System treatment delivering focused ultrasound energy<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 | 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 | 90 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Aesthetic Improvement at 90 Days Post-treatment | At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale. | 90 Days post-treatment | 
| Global Aesthetic Improvement at 180 Days Post-treatment | At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale. | 180 days post-treatment | 
| 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. | 90 Days post-treatment | 
| Patient Satisfaction Questionnaire | Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. Pre-treatment and Day 180 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. | 180 days post-treatment |