Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System

Study Overview
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Brief Summary
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This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner below the surface of the skin.

Detailed Description
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The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System to obtain improvement in overall lifting and tightening of skin.

Official Title
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Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck

Conditions
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Facial and Neck Skin Laxity

Intervention / Treatment
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* Device: Ulthera® System treatment


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. Skin laxity in the lower face and neck. Willingness and ability to comply with protocol requirements and return for follow-up visits. Provides written informed consent and HIPAA authorization. Exclusion Criteria: Pregnant or lactating. Presence of an active systemic or local skin disease that may affect wound healing. Severe solar elastosis. Excessive subcutaneous fat in the face and lower neck. Excessive skin laxity on the face and neck. Significant scarring in areas to be treated. Significant open facial wounds or lesions. Severe or cystic acne on the face. Presence of a metal stent or implant in the facial area to be treated.

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Ulthera® System treatment of the submental and submandibular regions at two treatment depths, and the lower neck region at one treatment depth. | Device: Ulthera® System treatment<br>* Single treatment of focused ultrasound energy delivered below the surface of the skin.<br>* Other names: Ultherapy;|
| Active Comparator: Group B<br>Ulthera® System treatment of skin above the jawline, as well as the submental, submandibular and lower neck regions. | Device: Ulthera® System treatment<br>* Single treatment of focused ultrasound energy delivered below the surface of the skin.<br>* Other names: Ultherapy;|
| Active Comparator: Group C<br>Ulthera® System treatment of the submental, submandibular, and the lower neck regions at two treatment depths. | Device: Ulthera® System treatment<br>* Single treatment of 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 |
| --- | --- | --- |
| Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity | Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis. | 90 Days post-treatment | 
| Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP | Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis. A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results. | 90 Days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively. | At 60 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows: - Very Much Improved - Much Improved - Improved - No Change - Worse Any Improvement includes participants assessed in categories 1-3 | 60 days post-treatment | 
| Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively. | At 90 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows: - Very Much Improved - Much Improved - Improved - No Change - Worse Any Improvement includes participants assessed in categories 1-3 | 90 days post-treatment | 
| Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity , as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively. | At 180 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows: - Very Much Improved - Much Improved - Improved - No Change - Worse Any Improvement includes participants assessed in categories 1-3 | 180 days post-treatment | 
| Patient Satisfaction 90 Days Post-treatment | Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the areas treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 90 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included. | 90 Days post-treatment | 
| Patient Satisfaction Questionnaire 180 Days Post-treatment | Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the ares treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 180 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included. | 180 days post-treatment | 
| L'Oreal Photographic Scale Baseline | At baseline, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category: Horizontal neck folds (Grades 0-6) Neck sagging (Grades 0-7); Texture (Female grades 0-5; male grades 0-7); Ptosis (Female grades 0-5; males grades 0-7). | Baseline | 
| L'Oreal Photographic Scale 90 Days Post-treatment | At 90 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category: Horizontal neck folds (Grades 0-6) Neck sagging (Grades 0-7); Texture (Female grades 0-5; male grades 0-7); Ptosis (Female grades 0-5; males grades 0-7). | 90 Days post-treatment | 
| L'Oreal Photographic Scale 180 Days Post-treatment | At 180 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category: Horizontal neck folds (Grades 0-6) Neck sagging (Grades 0-7); Texture (Female grades 0-5; male grades 0-7); Ptosis (Female grades 0-5; males grades 0-7). | 180 Days post-treatment |