NCT01708512

Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck

Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of Facial and Neck Skin Laxity Using a Customized, High-Density and Vectoring Treatment Approach

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

Summary

All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.

Detailed description

This is a prospective, single-center clinical trial to evaluate the efficacy of the Ulthera® System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.

Conditions

• Skin Laxity

Interventions

Type	Name	Description
DEVICE	Ulthera System Treatment	Focused ultrasound energy delivered below the surface of the skin

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-12-01
• Completion: 2013-07-01
• First posted: 2012-10-17
• Last updated: 2017-11-24

Locations

1 site across 1 country: United States