NCT01422538

Ultherapy™ Treatment Following Sculptra® Treatment

Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Following Sculptra® Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.

Detailed description

This study is a prospective,single-center, randomized clinical trial. Up to thirty (30) subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up to 10 subjects per group.

Conditions

• Skin Laxity

Interventions

Type	Name	Description
DEVICE	Ulthera® System	Focused ultrasound energy delivered below the surface of the skin on the lower face.
DRUG	Sculptra®	Injectable filler reconstituted prior to use. Injections are administered to the lower face in a combination of cross-hatching and fanning techniques. The Sculptra is injected in two treatment sessions 6 weeks apart.
OTHER	Sculptra® treatment followed by Ultherapy™ treatment	Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-06-01
• Completion: 2012-09-01
• First posted: 2011-08-24
• Last updated: 2017-12-13
• Results posted: 2013-08-27

Locations

1 site across 1 country: United States