Evaluation of the Ulthera® System for Treatment of the Brachia

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Ultherapy™ treatment	Ulthera® System	Each enrolled subject will receive a bilateral Ultherapy™ treatment of the upper arms

Primary Outcome Measures

Name	Time	Method
Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity	Baseline to 90 days post-treatment	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.

Secondary Outcome Measures

Name	Time	Method
Change in Dermal Thickness	Baseline to180 days post-treatment	Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.
Overall Aesthetic Improvement	Baseline to180 days post-treatment	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: 1. - Very Much Improved 2. - Much Improved 3. - Improved 4. - No Change 5. - Worse
Patient Satisfaction	Baseline to 180 days post-treatment	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.
Quantitative Improvement in Skin Laxity	Baseline to 90 days post-treatment	Assess change in brachial volume based on brachial tissue measurements.