Treatment of the Face and Neck With Lower Ulthera System Energy Settings

Study Overview
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Brief Summary
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Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Detailed Description
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This trial is a prospective, single-site, double-blinded, randomized, split-face design. Subjects will be randomized to one of three treatment groups, receiving treatment using different energy levels. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.

Official Title
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Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck With Lower Energy Settings

Conditions
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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, age 30 to 65 years. Subject in good health. Skin laxity on the face and neck Exclusion Criteria: Presence of an active systemic or local skin disease that may affect wound healing. Severe solar elastosis. Excessive subcutaneous fat in the face or neck. Excessive skin laxity on the face or neck. Significant scarring in areas to be treated. Open wounds or lesions in the area to be treated. Severe or cystic acne on the 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Subjects will receive an increased density Ulthera System Treatment over the full face but with the energy turned down to the second highest level of four possible energy settings on one side of the face. | Device: Ulthera System Treatment<br>* Focused ultrasound energy delivered below the surface of the skin<br>* Other names: Ultherapy™;|
| Active Comparator: Group B<br>Subjects will receive an increased density guideline Ulthera System Treatment over the full face but with the energy turned down to the lowest level of four possible energy settings on one side of the face. | Device: Ulthera System Treatment<br>* Focused ultrasound energy delivered below the surface of the skin<br>* Other names: Ultherapy™;|
| Active Comparator: Group C<br>Subjects will receive an increased density guideline Ulthera System Treatment over the full face with the exception that a 4 MHz transducer will be used on the upper face in place of a7 MHz transducer, with the energy turned down to the lowest level of four possible energy settings. | 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 |
| --- | --- | --- |
| Subjects' Assessment of Pain During Treatment With Lower Energy Settings | Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible. Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed. | Participants were assessed for the duration of study treatment, an average of 75 minutes | 
| Overall Improvement in Skin Laxity on the Face and Neck | A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group. | 90 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Assessment of Brow Lift at 90 Days Post-treatment | Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings. The number of subjects with 1 mm or more brow lift is reported. Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed. | 90 days post-treatment | 
| Subject Assessment of Improvement at 90 Days Post-treatment | Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck. | 90 days post-treatment | 
| Subject Assessment of Improvement at 180 Days Post-treatment | Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck. | 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