Lifting and Tightening of the Face and Neck Following an Increased Density Treatment

Not Applicable

Completed

Conditions: Skin Laxity

Interventions: Device: Ulthera System Treatment

Registration Number: NCT01519206

Lead Sponsor: Ulthera, Inc

Brief Summary: The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.

Detailed Description: All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days, 90 days, 180 days and 1 year following treatment.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

Inclusion Criteria

Male or female, aged 30 to 65 years
Subject in good health
Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study

Exclusion Criteria

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
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, a pacemaker, or cochlear implants

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultherapy treatment	Ulthera System Treatment	Ulthera System Treatment

Primary Outcome Measures

Name	Time	Method
Improvement in Overall Lifting and Tightening of Skin	Baseline to 90 days post treatment	Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.

Secondary Outcome Measures

Name	Time	Method
Subjects' Assessment of Pain	During Ulthera treatment	Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Subjects rated pain for each transducer, in each treatment region. For statistical analyses, NRS scores were averaged for each transducer depth.
Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment	Baseline to 90 days, 180 days and 1 year post-treatment	Subject satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days, 180 days and 1 year post-treatment. Subjects indicated how satisfied they were with their study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and post-treatment photographs were available for viewing at each follow-up visit interval. Subjects also had a mirror available for real time assessment, comparing their image in the mirror with pre-treatment and post-treatment photos.
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.	Baseline to 60 days, 90 days, 180 days and 1 year post-treatment	Improvement was assessed based on Global Aesthetic Improvement Scale (GAIS) scores. The GAIS was completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos. The PGAIS was completed by a clinician assessor; SGAIS was completed by the study subject. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows: 1. - Very Much Improved 2. - Much Improved 3. - Improved 4. - No Change 5. - Worse