NCT01485107

Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté

Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Décolleté

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: Female
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.

Detailed description

This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale scores and chest measurements will be assessed prior to study treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.

Conditions

• Skin Laxity of the décolleté

Interventions

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

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-01-01
• Completion: 2012-05-01
• First posted: 2011-12-05
• Last updated: 2017-11-24

Locations

1 site across 1 country: United States