Clinical Trial: Simulines Non-Inferiority Pivotal Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Non-Inferiority Study of the Safety and Efficacy of Ultherapy® Using Standard Versus Simulines Transducers at a Reduced Energy Level for Patient Comfort

Brief Summary: Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one of two treatment groups. Subjects meeting all entrance criteria will receive study treatment, then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365 days post treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit for qualitative and quantitative assessments of efficacy.

Detailed Summary:

This is a prospective, randomized, double blinded, multi-center, parallel arm, non-inferiority, pivotal clinical trial to demonstrate that the safety and efficacy of a new transducer which delivers two simultaneous lines of treatment at the same treatment depth is not inferior to a standard transducer to improve jawline definition and submental skin laxity.

Changes from baseline in quantitative measures of neck and submental lift will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, Merz Jawline Grading Scale scores, 3D volumetric changes from baseline to post treatment, patient satisfaction and patient-reported improvement will be obtained.


Sponsor: Ulthera, Inc

Current Primary Outcome: Quantitative measurements of neck and submental lift [ Time Frame: 90 days post treatment ]

Subject response as assessed by methodology and success criteria used to support the FDA clearance of the submental/neck lift indication for Ultherapy®. Response is defined as ≥20 mm2 reduction in 2D submental area from baseline.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quantitative measurements of neck and submental lift [ Time Frame: 180 days post treatment ]
    Subject response as assessed by methodology and success criteria used to support the FDA clearance of the submental/neck lift indication for Ultherapy®. Response is defined as ≥20 mm2 reduction in 2D submental area from baseline.
  • Quantitative measurements of neck and submental lift [ Time Frame: 365 days post treatment ]
    Subject response as assessed by methodology and success criteria used to support the FDA clearance of the submental/neck lift indication for Ultherapy®. Response is defined as ≥20 mm2 reduction in 2D submental area from baseline.
  • Overall lifting and tightening of skin [ Time Frame: 90 days post treatment ]
    As determined by a masked, qualitative assessment of post treatment photographs compared to baseline.
  • Overall lifting and tightening of skin [ Time Frame: 180 days post treatment ]
    As determined by a masked, qualitative assessment of post treatment photographs compared to baseline.
  • Overall lifting and tightening of skin [ Time Frame: 365 days post treatment ]
    As determined by a masked, qualitative assessment of post treatment photographs compared to baseline.
  • Mean change from baseline to post treatment on the validated Merz Jawline Grading Scale (MJGS) [ Time Frame: 90 days post treatment ]
    As assessed by independent masked evaluators comparing baseline study photographs to post treatment study photographs.
  • Volumetric changes from baseline [ Time Frame: 90 days ]
    As determined by comparing 3D imaging at baseline to post treatment.
  • Volumetric changes from baseline [ Time Frame: 180 days ]
    As determined by comparing 3D imaging at baseline to post treatment.
  • Volumetric changes from baseline [ Time Frame: 365 days ]
    As determined by comparing 3D imaging at baseline to post treatment.
  • Treatment times using Simulines versus Standard transducers [ Time Frame: During study treatment (Day 0 post treatment) ]
    Based on a comparison of average time to complete treatment using each transducer type.
  • Subjects' treatment-related comfort level [ Time Frame: During study treatment (Day 0 post treatment) ]
    Based on a comparison of average pain scores using a validated Numeric Rating Scale using each transducer type.
  • 90-day Subject Global Aesthetic Improvement (SGAIS) Scale [ Time Frame: 90 days post treatment ]

    SGAIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:

    • 1=very much improved
    • 2=much improved
    • 3=improved
    • 4=no change
    • 5=worse
  • 180-day Subject Global Aesthetic Improvement (SGAIS) Scale [ Time Frame: 180 days post treatment ]

    SGAIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:

    • 1=very much improved
    • 2=much improved
    • 3=improved
    • 4=no change
    • 5=worse
  • 365-day Subject Global Aesthetic Improvement (SGAIS) Scale [ Time Frame: 365 days post treatment ]

    SGAIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:

    • 1=very much improved
    • 2=much improved
    • 3=improved
    • 4=no change
    • 5=worse
  • 90-day Clinician Global Aesthetic Improvement (CGAIS) Scale [ Time Frame: 90 days post treatment ]

    CGAIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:

    • 1=very much improved
    • 2=much im

      Original Secondary Outcome: Same as current

      Information By: Ulthera, Inc

      Dates:
      Date Received: April 4, 2016
      Date Started: April 4, 2016
      Date Completion: November 1, 2017
      Last Updated: May 1, 2017
      Last Verified: May 2017