Evaluation of the Ulthera System for the Treatment of the Decolletage

Study Overview
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Brief Summary
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This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera® treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Official Title
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Prospective, Multi-center, Pivotal Trial Evaluating the Safety and Effectiveness of the Ulthera® System for Improvement in Lines and Wrinkles of the Décolletage

Conditions
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Chest 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: Female, aged 35 to 70 years. Subject in good health. Moderate to severe skin lines and wrinkles on the décolletage; grade of ≥4 on a chest wrinkle scale. 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. Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating. Absence of physical conditions unacceptable to the investigator. Willingness and ability to provide written consent for study-required photography. Willingness and ability to provide written informed consent. 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. 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 hypertrophic scarring. Inability to understand the protocol or to give informed consent. Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the décolletage area within two weeks prior to study participation or during the study. Marked décolletage asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin. History of chronic drug or alcohol abuse. History of autoimmune disease. Concurrent therapy that would interfere with the evaluation of the safety or effectiveness of the study device. Subjects who anticipate the need for surgery or overnight hospitalization during the study. Subjects who have a history of poor cooperation, noncompliance with medical treatment, or unreliability. Concurrent enrollment in any study involving the use of investigational devices or drugs. Current smoker or history of smoking in the last one year. History of using the following prescription medications: Topical Retinoids to the area within the past two weeks; Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix). Psychiatric drugs that would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulthera System Treatment<br>A single triple-depth Ulthera System treatment of the decolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. | 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 |
| --- | --- | --- |
| Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment | Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Improvement = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set and correctly chose the Post treatment photo. Incorrect = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo. | 90 Days post-treatment | 
| Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment | Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline. Improvement = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set and correctly chose the Post treatment photo. Incorrect = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo. | 180 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Aesthetic Improvement at 90 Days Post-treatment | The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors: Very much improved Much improved Improved No change Worse The scale was completed in two steps: Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs. Improved = Very Much Improved + Much Improved + Improved | 90 days post-treatment | 
| Overall Aesthetic Improvement at 180 Days Post-treatment | The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors: Very much improved Much improved Improved No change Worse The scale was completed in two steps: Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs. Improved = Very Much Improved + Much Improved + Improved | 180 days post-treatment | 
| Subject Satisfaction at 90 Days Post-treatment | Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors: Very Satisfied Satisfied Neither Satisfied or Dissatisfied Dissatisfied Very Dissatisfied Satisfied= Very Satisfied + Satisfied Dissatisfied=Dissatisfied + Very Dissatisfied | 90 days post-treatment | 
| Subject Satisfaction at 180 Days Post-treatment | Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors: Very Satisfied Satisfied Neither Satisfied or Dissatisfied Dissatisfied Very Dissatisfied Satisfied = Very Satisfied + Satisfied Dissatisfied = Dissatisfied + Very Dissatisfied | 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., Micro-focused Ultrasound with Visualization (MFU-V)