Evaluation of the Ulthera® System for Treatment of the Face and Neck

Study Overview
=================
Brief Summary
-----------------
Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Detailed Description
-----------------
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.

Official Title
-----------------
Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Facial Tissue and Improvement in Jawline Definition and Submental Skin Laxity

Conditions
-----------------
Wrinkles, Rhytids, Skin Laxity

Intervention / Treatment
-----------------
* Device: Ulthera® Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged 30 to 65 years. Subject in good health. Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale. Mild to moderate rhytids in the periorbital or perioral region. Mild to moderate laxity in the areas to be treated, which includes length and depth of lines. Mild to moderate vertical perioral lines Mild to moderate marionette lines. Subjects who desire lift and tightening of periorbital, perioral, and cheek tissue, improvement in jawline definition and/or submental skin laxity Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period. Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. Exclusion Criteria: 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. Deep wrinkles, numerous lines, with or without redundant skin in the areas to be treated. Excessive hooding with or without redundant skin in the areas to be treated.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulthera® treatment<br>All enrolled subjects will receive one full face and neck Ulthera® treatment. | Device: Ulthera® Treatment<br>* Focused ultrasound energy delivered below the surface of the skin.<br>* Other names: Ulthera, Inc.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in facial wrinkles and lifting and tightening of skin | Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline | 90 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall aesthetic improvement | Aesthetic improvement determined based on GAIS scores at follow-up, and the change in facial pigmentation and Fitzpatrick Facial Wrinkle Scale scores from baseline. | Participants will be followed up to 180 days post-treatment | 
| Overall patient satisfaction | Determined based on Patient Satisfaction and Quality of Life questionnaire scores. | 90 and 180 day post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultherapy™ treatment, Ulthera® System, Ulthera, Inc., Ultrasound treatment for skin tightening