A Retrospective Study to Evaluate the Effectiveness of the Ulthera System

Study Overview
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Brief Summary
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Up to 120 subjects within the study site's practice who have already had an Ultherapy™ treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained at each follow-up visit.

Detailed Description
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This is a retrospective, single-center clinical trial to evaluate the efficacy of the Ulthera System for non-invasive treatment of skin texture and laxity six months after treatment. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.

Official Title
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Retrospective Evaluation of the Ulthera System for Lifting and Tightening of the Face and Neck

Conditions
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Skin Laxity, Wrinkles

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age 25-85 years. Subject in good health. Received Ultherapy™ treatment prior to or on October 1, 2011, and must have had pre-treatment baseline photographs taken. Willingness and ability to comply with protocol requirements, including returning for follow-up visits. Absence of physical or psychological conditions unacceptable to the investigator. Exclusion Criteria: Presence of an active systemic or local skin disease that may affect wound healing. Significant scarring in areas treated. Open wounds or lesions in the areas treated. Severe or cystic acne on the areas treated. Inability to understand the protocol or to give informed consent.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 85 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ulthera-treated subjects<br>All enrolled subjects will have received an Ulthera treatment prior to enrollment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Overall Lifting and Tightening of the Skin | Determined by a masked, qualitative assessment of photographs at 180 days post treatment compared to pre-treatment baseline photographs. A panel of three blinded assessors reviewed pre-treatment and post-treatment photos. Each blinded assessor was provided an identical set of pre-treatment and Day 180 post-treatment photos to assess. The pre/post treatment photos were consistent in lighting, subject positioning and focus. The visit interval of each photo, i.e. pre and post treatment, was NOT marked. Each blinded assessor conducted their assessment independently with no input from another blinded assessor, comparing each set of photos. Each assessor indicated those subjects assessed as improved. | Baseline to 180 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Aesthetic Improvement | Overall aesthetic improvement was assessed based on a Global Aesthetic Improvement Scale (GAIS) scores; PGAIS completed by a clinician assessor, SGAIS completed by the study subject. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: = Very Much Improved = Much Improved = Improved = No Change = Worse | Baseline to 180 days post-treatment | 
| Subject Perception of Age | Percentage of subjects rated as looking younger as measured using a Subject Perception of Age questionnaire. | Baseline to 180 days post-treatment | 
| Patient Satisfaction | Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire. | 180 days post-treatment | 

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