A Retrospective Study to Evaluate the Effectiveness of the Ulthera System
Up to 120 subjects within the study site's practice who have already had an Ultherapy™ treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained at each follow-up visit.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Retrospective Evaluation of the Ulthera System for Lifting and Tightening of the Face and Neck|
- Improvement in overall lifting and tightening of the skin [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]Determined by a masked, qualitative assessment of photographs at 180 days post treatment compared to pre-treatment baseline photographs.
- Overall aesthetic improvement [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]According to the GAIS assessment by the investigator and the subject compared to pre-treatment photos.
- Subject lifestyle satisfaction [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]Measured using a Subject Lifestyle, Subject Perception of Age, Self-rating of Attractiveness and Patient Satisfaction Questionnaires.
|Study Start Date:||October 2011|
|Study Completion Date:||August 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
All enrolled subjects will have received an Ulthera treatment prior to enrollment.
This is a retrospective, single-center clinical trial to evaluate the efficacy of the Ulthera System for non-invasive treatment of skin texture and laxity six months after treatment. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.
|United States, California|
|Dermatology Cosmetic Laser Associates|
|San Diego, California, United States, 92121|
|Principal Investigator:||Mitchel Goldman, MD||Dermatology Cosmetic Laser Associates|