Clinical Trial: Lifting and Tightening of the Face in Subjects With Skin of Darker Color
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity in Patients Wi
Brief Summary: This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.
Detailed Summary: The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.
Sponsor: Ulthera, Inc
Current Primary Outcome: Change in Overall Lifting and Tightening of Treated Tissue [ Time Frame: 90 days post treatment ]
Original Primary Outcome: Improvement in overall lifting and tightening of skin [ Time Frame: 90 days post treatment compared to baseline ]
Current Secondary Outcome:
- Global Aesthetic Improvement at 90 Days Post-treatment [ Time Frame: 90 Days post-treatment ]At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.
- Global Aesthetic Improvement at 180 Days Post-treatment [ Time Frame: 180 days post-treatment ]At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.
- Patient Satisfaction Questionnaire [ Time Frame: 90 Days post-treatment ]Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.
- Patient Satisfaction Questionnaire [ Time Frame: 180 days post-treatment ]Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.
Original Secondary Outcome:
Information By: Ulthera, Inc
Dates:
Date Received: June 6, 2011
Date Started: March 2011
Date Completion:
Last Updated: February 10, 2014
Last Verified: February 2014