NCT02736825

Simulines Non-Inferiority Pivotal Study

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

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 description

This is a prospective, randomized, double blinded, multi-center, parallel arm, non-inferiority, pivotal clinical trial to demonstrate the efficacy of the Ultherapy treatment with prototype 2 simulines transducers (4-3.0 Smm and 4-4.5 Smm) at energy level (EL) 2 is non-inferior to treatment with standard transducers (7-3.0 mm and 4-4.5mm) at EL 2 for lifting the lower face and neck and to demonstrate the safety of treatment with prototype 2 simulines transducers is similar to treatment with standard transducers. 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.

Conditions

• Skin Laxity

Interventions

Type	Name	Description
DEVICE	Ulthera System with standard transducer	Focused ultrasound energy delivered below the surface of the skin using commercially available transducer to deliver one line of treatment at a time
DEVICE	Ulthera System with prototype 2 simulines transducer	Focused ultrasound energy delivered below the surface of the skin using new transducer to deliver two lines of treatment simultaneously

Timeline

• Start date: 2016-04-11
• Primary completion: 2017-01-20
• Completion: 2017-04-25
• First posted: 2016-04-13
• Last updated: 2020-02-19
• Results posted: 2020-02-19

Locations

8 sites across 1 country: United States