Reducing Wrinkles Around the Eyes Using the Ulthera® System

Study Overview
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Brief Summary
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The purpose of this prospective, multi-center, single treatment study is to evaluate the clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of the skin.

Detailed Description
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The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for non-invasive treatment to reduce wrinkles around the eyes.

Official Title
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Evaluation of the Ulthera® System for Obtaining a Reduction of Wrinkles Around the Eyes

Conditions
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Periorbital Wrinkles

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. Mild to moderate rhytids in the periorbital region. Willingness and ability to comply with protocol requirements and return for follow-up visits. Not pregnant. Provide written informed consent and HIPAA authorization. Exclusion Criteria: Presence of an active systemic or local skin disease that may affect wound healing. Severe solar elastosis. Excessive subcutaneous fat in the face. Deep wrinkles, numerous lines, with or without redundant skin in the area to be treated. Excessive hooding, with or without redundant skin, in the areas to be treated. 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>Ulthera treatment to the upper face. | Device: Ulthera® System treatment<br>* Focused ultrasound energy delivered below the surface of the skin.<br>* Other names: Ultherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes | Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline. | 90 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment | At 60 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: = Very Much Improved = Much Improved = Improved = No Change = Worse Any Improvement includes subjects assessed in categories 1-3. | 60 days post-treatment | 
| Improvement in Periorbital Wrinkles and Rhytids Around the Eyes 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. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: = Very Much Improved = Much Improved = Improved = No Change = Worse Any Improvement includes subjects assessed in categories 1-3. | 90 days post-treatment | 
| Improvement in Periorbital Wrinkles and Rhytids Around the Eyes 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. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: = Very Much Improved = Much Improved = Improved = No Change = Worse Any Improvement includes subjects assessed in categories 1-3. | 180 days post-treatment | 
| Patient Satisfaction Questionnaire 90 Days Post-treatment | Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment. | 90 days post-treatment | 
| Patient Satisfaction Questionnaire at 180 Days Post-treatment | Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment. | 180 days post-treatment | 

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