NCT01981252

Peri-orbital and Peri-oral Wrinkle Reduction Trial

Evaluation of the Safety and Efficacy of the Ulthera® System for Wrinkle Reduction in the Peri-orbital and Peri-oral Regions

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is prospective, multi-center, single-blinded, non-randomized clinical trial. Enrolled subjects will receive two Ulthera® treatments on the peri-orbital and peri-oral regions, each treatment provided 30 days apart. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Conditions

• Peri-orbital Wrinkles
• Peri-oral Wrinkles

Interventions

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

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-11-11
• Last updated: 2017-11-24

Locations

5 sites across 1 country: United States