NCT01368835

Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue

Evaluation of the Ulthera™ System For Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment to obtain lift and tightening of the cheek tissue and improve jawline definition and submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a focused manner below the surface of the skin

Detailed description

The primary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment to obtain lift and tighten the cheek tissue. The secondary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment for improvement in jawline definition and submental skin laxity at 3 and 6 months compared to baseline based on the consensus of the three masked reviewers.

Conditions

• Mild to Moderate Skin Laxity on Cheek
• Mild to Moderate Skin Laxity on Upper Neck
• Mild to Moderate Subcutaneous Fat on Cheek
• Mild to Moderate Subcutaneous Fat on Upper Neck

Interventions

Type	Name	Description
DEVICE	Ulthera treatment	treatment of cheeks and upper neck area of face

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-12-01
• Completion: 2011-04-01
• First posted: 2011-06-08
• Last updated: 2017-12-13
• Results posted: 2013-08-15