Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment

Study Overview
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Brief Summary
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Up to 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.

Detailed Description
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This is a prospective, single-site, non-randomized clinical trial efficacy of an additional Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous Ulthera clinical trial. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.

Official Title
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Feasibility Study: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Neck in Post-Surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ultherapy™ Treatment

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. BMI < 30. Skin laxity in the submental area as demonstrated by a grade II or III on the Knize scale for classification of cosmetic deformity of the cervicomental angle Previous participation in ULT-107, and adequate compliance with all treatment and follow-up visits. Groups (surgery or surgery naïve) will be designated based on group assigned in ULT-107). Have not had any concomitant surgical or skin tightening procedures since their Ultherapy™ treatment with ULT-107. Exclusion Criteria: Pregnant, lactating, or are planning to become pregnant, and/or not using a reliable form of birth control. Presence of an active systemic or local skin disease that may affect wound healing. Severe solar elastosis. Excessive subcutaneous fat on the cheeks. Excessive skin laxity on the lower face and 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulthera treatment group<br>All subjects will receive an Ulthera System Treatment | 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 |
| --- | --- | --- |
| Improvement in lower face and neck skin laxity | Efficacy will be assessed using the 90-day images compared to baseline | 90 days post-treatment | 
| Cervicomental angle | Efficacy will be assessed using the 90-day images compared to baseline. | 90 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall aesthetic improvement | Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 90 days post-treatment. | 90 days post-treatment | 
| Patient satisfaction | Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment. | 90 days post-treatment | 
| Pain Assessment | Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment. | Treatment visit | 
| Patient Satisfaction | Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment. | 180 days post-treatment | 
| Overall aesthetic improvement | Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 180 days post-treatment. | 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