NCT01713998

Treatment of the Face and Neck With Lower Ulthera System Energy Settings

Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck With Lower Energy Settings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Detailed description

This trial is a prospective, single-site, double-blinded, randomized, split-face design. Subjects will be randomized to one of three treatment groups, receiving treatment using different energy levels. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will 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: 2011-09-01
• Primary completion: 2012-06-01
• Completion: 2012-10-01
• First posted: 2012-10-25
• Last updated: 2017-12-11
• Results posted: 2014-02-21

Locations

1 site across 1 country: United States