Feasibility Study: Lifting and Tightening of the Elbows
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01708382|
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Skin Laxity||Device: Ulthera System Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Elbow Tissue - A Feasibility Study|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||February 2013|
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™
- Overall improvement of skin laxity in the areas treated [ Time Frame: 90 days post-treatment ]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 ]GAIS scores will be obtained by the Investigator and subjects at all visits excluding baseline. Additionally, subject satisfaction questionnaires will also be obtained.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|