Feasibility Study: Ulthera Treatment of the Buttocks and Thighs
|ClinicalTrials.gov Identifier: NCT01708460|
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 :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening the Buttocks and Thighs|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||July 2013|
Experimental: Ulthera-treated subjects
All enrolled subjects will receive one Ultherapy treatment to one side of the body in the lateral buttock region. Following study completion, subjects may elect to receive a balancing treatment to the other side of the body.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ultherapy™
- Overall lifting and tightening of the buttocks and thighs. [ Time Frame: 90 days post-treatment ]As determined by a masked, qualitative assessment of photographs at three months post-treatment compared to baseline.
- Overall aesthetic improvement. [ Time Frame: 90 and 180 days post-treatment. ]As determined by GAIS completed by the Investigator and subject.
- Overall subject satisfaction. [ Time Frame: 90 and 180 days post-treatment ]As determined by subjects' completion of a Patient Satisfaction Questionnaire.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708460
|United States, New York|
|Skin Laser and Surgery Specialist of New York and New Jersey|
|New York, New York, United States, 10022|
|Principal Investigator:||David Goldberg, MD||Skin Laser and Surgery Specialist of New York and New Jersey|