Evaluation of the Ulthera® System for Treatment of the Brachia

Study Overview
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Brief Summary
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This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.

Detailed Description
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This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study photographs of the upper arms will be taken prior to treatment, immediately post-treatment, and at each follow-up visit. Brachial volume and dermal thickness measurements will be obtained.

Official Title
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Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Brachia

Conditions
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Brachial Ptosis

Intervention / Treatment
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* Device: Ulthera® System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 19 - 55 years. Subject in good health. Subjects who desire lift and tightening of the brachia and improvement in skin laxity. Mild to moderate laxity of the upper arm. Mild to moderate subcutaneous fat of the upper arm. Mild crepiness of the skin of the upper arm. 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 in the upper arm. Excessive skin laxity in the upper arm. Significant scarring in areas to be treated. Significant open wounds or lesions in the treatment areas. 7. Severe or cystic acne in the treatment areas.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultherapy™ treatment<br>Each enrolled subject will receive a bilateral Ultherapy™ treatment of the upper arms | Device: Ulthera® System<br>* Focused ultrasound energy delivered below the surface of the skin.<br>* Other names: Ultrasound treatment for skin tightening;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity | Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. | Baseline to 90 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Improvement in Skin Laxity | Assess change in brachial volume based on brachial tissue measurements. | Baseline to 90 days post-treatment | 
| Change in Dermal Thickness | Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated. | Baseline to 90 days post-treatment | 
| Change in Dermal Thickness | Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated. | Baseline to180 days post-treatment | 
| Overall Aesthetic Improvement | Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows: - Very Much Improved - Much Improved - Improved - No Change - Worse | Baseline to 60 days post-treatment | 
| Overall Aesthetic Improvement | Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows: - Very Much Improved - Much Improved - Improved - No Change - Worse | Baseline to 90 days post-treatment | 
| Overall Aesthetic Improvement | Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows: - Very Much Improved - Much Improved - Improved - No Change - Worse | Baseline to180 days post-treatment | 
| Patient Satisfaction | Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. | Baseline to 90 days post-treatment | 
| Patient Satisfaction | Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. | Baseline to 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.