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: Baseline to 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. A panel of three blinded assessors reviewed pre-treatment and post-treatment photos. Each blinded assessor was provided an identical set of pre-treatment and Day 180 post-treatment photos to assess. The pre/post treatment photos were consistent in lighting, subject positioning and focus. The visit interval of each photo, i.e. pre and post treatment, was NOT marked. Each blinded assessor conducted their assessment independently with no input from another blinded assessor, comparing each set of photos. Each assessor indicated those subjects assessed as improved.
- Overall Aesthetic Improvement [ Time Frame: Baseline to 180 days post-treatment ] [ Designated as safety issue: No ]
Overall aesthetic improvement was assessed based on a Global Aesthetic Improvement Scale (GAIS) scores; PGAIS completed by a clinician assessor, SGAIS completed by the study subject. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
- = Very Much Improved
- = Much Improved
- = Improved
- = No Change
- = Worse
- Subject Perception of Age [ Time Frame: Baseline to 180 days post-treatment ] [ Designated as safety issue: No ]Percentage of subjects rated as "looking younger" as measured using a Subject Perception of Age questionnaire.
- Patient Satisfaction [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519934
|United States, California|
|Dermatology Cosmetic Laser Associates|
|San Diego, California, United States, 92121|
|Principal Investigator:||Mitchel Goldman, MD||Dermatology Cosmetic Laser Associates|