NCT01713907

Evaluation of the Ulthera® System for Treatment of the Face and Neck

Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Facial Tissue and Improvement in Jawline Definition and Submental Skin Laxity

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 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 is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.

Conditions

• Wrinkles
• Rhytids
• Skin Laxity

Interventions

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

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-10-01
• Completion: 2012-01-01
• First posted: 2012-10-25
• Last updated: 2017-11-24

Locations

1 site across 1 country: United States