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 ]

The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos


Original Primary Outcome: Improvement in overall lifting and tightening of skin [ Time Frame: 90 days post treatment compared to baseline ]

Improvement in overall lifting and tightening of skin as determined by masked qualitative assessment of 90 day post treatment photographs 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