Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin on the Neck

Study Overview
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Brief Summary
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Study is a prospective clinical trial to evaluate the efficacy of the Ulthera® System to improve Lifting Skin on the Neck. Changes from baseline in the FACE-Q Appraisal of Neck scale score and Global Aesthetic Improvement Scale scores will be assessed at study follow-up visits.

Detailed Description
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Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed, and all subjects will check the FACE-Q Appraisal of Neck scale score Treatment: The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 200 260 lines of 3.0 and 4.5 probe respectively on the subject's neck. Post-Treatment: All subjects will visit the Institution at 12 weeks from the day of procedure, and will take photos of the neck. Efficacy evaluation will performed by the Photographic Evaluator.

Official Title
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Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin

Conditions
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Wrinkles

Intervention / Treatment
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* Device: Ultherapy™ System


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 Subjects who desire improvement in neck skin Exclusion Criteria: Presence of an active systemic infectious disease general disease or skin disorder in the area to be treated Pregnant or lactating subjects Previous episode of facial or neck surgery for wrinkle correction Subjects who have aesthetic addiction, drug abuse, alcohol abuse Subjects who were treated Botox or Filler at the neck area Subjects who had Auto-Immune disease

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultherapy™ System<br>Ultherapy™ System | Device: Ultherapy™ System<br>* The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 200 260 lines of 3.0 and 4.5 probe respectively on the subject's neck.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Assessment of Improvement at 12 weeks post-treatment | Investigator complete Global Aesthetic Improvement Scale at 12 weeks post-treatment by comparing subject's photographs | 12 weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Assessment of Improvement at 12 weeks post-treatment | Subjects complete a Patient Assessment Global Aesthetic Improvement Scale at 12 weeks posttreatment | 12 weeks post-treatment | 
| Subjects' Assessment of Pain during treatment | Pain score record using a Numeric Rating Scale (NRS,0-10) , with 0 representing no pain and 10 representing the worst pain possible. | Subjects were assessed for the duration of study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhytids, Skin Laxity