Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté

Study Overview
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Brief Summary
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Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.

Detailed Description
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This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale scores and chest measurements will be assessed prior to study treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.

Official Title
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Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Décolleté

Conditions
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Skin Laxity of the décolleté

Intervention / Treatment
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* Device: Ulthera® System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, aged 35 to 60 years. Subject in good health. Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté. 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. Scarring in areas to be treated. Tattoos in the areas to be treated. Patients with ports or defibrillators. Breast size >400cc each as measured by water displacement method. History of breast reduction surgery. Any open wounds or lesions in the area. Active and severe inflammatory acne in the region to be treated. Patients who have a history with keloid formation or hypertropic scarring

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

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 on the décolleté<br>All enrolled subjects will receive the study treatment. | Device: Ulthera® System<br>* Focused ultrasound energy delivered below the surface of the skin.<br>* Other names: Ultherapy™ treatment;|

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 skin | Lifting and tightening of décolleté skin as determined by a masked, qualitative assessment of photographs at 90 days posttreatment compared to baseline. | 90 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Laxity of the Décolleté | The amount of skin laxity will be assessed using the Fabi/Bolton 5-Point Chest Wrinkle Scale. Skin laxity will be assessed at each follow-up visit compared to baseline. | 90 and 180 days post-treatment | 
| Bilateral chest measurements | Measurements from mid-clavicle to nipple obtained at each follow-up visit compared to baseline to assess for lifting and tightening of skin. | 90 and 180 days post-treatment | 
| Overall aesthetic improvement | Based on Global Aesthetic Improvement Scale (GAIS) scores. | 90 and 180 days post-treatment | 
| Patient satisfaction | Subject-completed questionnaire. | 90 and 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