Evaluation of the Ulthera® System for Treatment of the Brachia
This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Brachia|
- Improvement in obtaining lift and tightening of brachial skin laxity [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]Assess improvement based on a masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.
- Quantitative improvement in skin laxity [ Time Frame: Participants will be followed up to 180 days post-treatment ] [ Designated as safety issue: No ]Assess change in brachial volume based on brachial tissue measurements.
- Improvement in dermal thickness [ Time Frame: Participants will be followed for up to 180 days following treatment #2. ] [ Designated as safety issue: No ]Based on ultrasonic skin analysis
- Overall aesthetic improvement [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]Based on GAIS scores
- Patient satisfaction [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]Based on Patient Satisfaction questionnaires
|Study Start Date:||June 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: Ultherapy™ treatment
Each enrolled subject will receive a bilateral Ultherapy™ treatment of the upper arms
Device: Ulthera® System
Focused ultrasound energy delivered below the surface of the skin.
This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study photographs of the upper arms will be taken prior to treatment, immediately post-treatment, and at each follow-up visit. Brachial volume and dermal thickness measurements will be obtained.
|United States, California|
|Sasaki Advanced Aesthetic Medical Center|
|Pasadena, California, United States, 91105|
|Principal Investigator:||Gordon Sasaki, MD FACS||Sasaki Advanced Aesthetic Medical Center|