Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck
All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of Facial and Neck Skin Laxity Using a Customized, High-Density and Vectoring Treatment Approach|
- Improvement in overall lifting and tightening of the skin [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]As determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline. The clinical response of Ulthera treatment will be assessed by comparing photographic images taken before and after the procedure.
- Overall aesthetic improvement [ Time Frame: 365 days post-treatment ] [ Designated as safety issue: No ]Global Aesthetic Improvement Scale scores will be obtained from the Investigator and subject, assessing improvement in skin laxity based on a comparison of post-treatment photos to pre-treatment photos.
|Study Start Date:||April 2012|
|Study Completion Date:||July 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Ultherapy™ study treatment
Each subject will receive a customized, high-density, vectored Ulthera System Treatment.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
This is a prospective, single-center clinical trial to evaluate the efficacy of the Ulthera® System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.