Lifting and Tightening of the Face and Neck Following an Increased Density Treatment
The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Efficacy and Safety of the Ulthera® System for Lifting and Tightening of the Face and Neck Following an Increased Density Treatment.|
- Improvement in Overall Lifting and Tightening of Skin [ Time Frame: Baseline to 90 days post treatment ] [ Designated as safety issue: No ]Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.
- Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment. [ Time Frame: Baseline to 60 days, 90 days, 180 days and 1 year post-treatment ] [ Designated as safety issue: No ]
Improvement was assessed based on Global Aesthetic Improvement Scale (GAIS) scores. The GAIS was completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos. The PGAIS was completed by a clinician assessor; SGAIS was completed by the study subject. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- - Very Much Improved
- - Much Improved
- - Improved
- - No Change
- - Worse
- Subjects' Assessment of Pain [ Time Frame: During Ulthera treatment ] [ Designated as safety issue: Yes ]Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Subjects rated pain for each transducer, in each treatment region. For statistical analyses, NRS scores were averaged for each transducer depth.
- Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment [ Time Frame: Baseline to 90 days, 180 days and 1 year post-treatment ] [ Designated as safety issue: No ]Subject satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days, 180 days and 1 year post-treatment. Subjects indicated how satisfied they were with their study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and post-treatment photographs were available for viewing at each follow-up visit interval. Subjects also had a mirror available for real time assessment, comparing their image in the mirror with pre-treatment and post-treatment photos.
|Study Start Date:||August 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: Ultherapy treatment
Ulthera System Treatment
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin.
All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days, 90 days, 180 days and 1 year following treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519206
|United States, New York|
|Laser & Skin Surgery Center of NY|
|New York, New York, United States, 10016|
|Principal Investigator:||Roy Geronemus, M.D.||Laser & Skin Surgery Center of NY|