Lifting and Tightening of the Face and Neck Following an Increased Density Treatment
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Efficacy and Safety of the Ulthera® System for Lifting and Tightening of the Face and Neck Following an Increased Density Treatment.|
- Improvement in overall lifting and tightening of skin [ Time Frame: 90 days post treatment ] [ Designated as safety issue: No ]Determined by a masked, qualitative assessment of photographs at three months post-treatment compared to baseline.
- Improvement in lower face skin laxity, jawline definition, and/or submental skin laxity. [ Time Frame: 60, 90, 180 days and 1 year post-treatment ] [ Designated as safety issue: No ]Assessed by a quantitative measure of submental skin lift, as assessed at all visits.
|Study Start Date:||August 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: Ultherapy treatment
Ulthera System Treatment
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin.
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.
|United States, New York|
|Laser & Skin Surgery Center of NY|
|New York, New York, United States, 10016|
|Principal Investigator:||Roy Geronemus, M.D.||Laser & Skin Surgery Center of NY|