Feasibility Study: Lifting and Tightening of the Elbows
Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on the elbows. 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Elbow Tissue - A Feasibility Study|
- Overall improvement of skin laxity in the areas treated [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]Determined by masked assessment analysis of photographs at 90 days post treatment compared to baseline.
- Aesthetic improvement [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]GAIS scores will be obtained by the Investigator and subjects at all visits excluding baseline. Additionally, subject satisfaction questionnaires will also be obtained.
|Study Start Date:||September 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Ultherapy treatment on the elbows
All enrolled subjects will receive one Ultherapy treatment to the elbows.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve skin laxity above the elbows. Masked assessment of pre- and post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708382
|United States, New York|
|New York Cosmetic, Skin and Laser Surgery Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Cameron K Rokhsar, MD||New York Cosmetic, Skin, and Laser Surgery Center|