NCT02441036

Gene Expression Following Ultherapy® Treatment

Evaluation of Changes in Gene Expression Following Ultherapy® Treatment

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Up to 25 subjects will be enrolled and randomized. Randomized subjects will receive one single-side Ulthera® treatment in the pre-auricular region on the face. At each subject's scheduled facelift procedure, resected tissue will be obtained for analysis.

Detailed description

This is a prospective, multi-center, pilot clinical trial to evaluate the molecular changes following an Ultherapy® treatment. Subjects will be randomized to one of five treatment groups and, based on study group assignment, will receive one single-side Ultherapy® treatment at varying timepoints prior to an already planned facelift procedure. Treatment will be delivered to the pre-auricular region on one side of the face; the contralateral side will serve as control. During an already planned facelift procedure, treated and non-treated resected tissue will be obtained for analysis.

Conditions

• Skin Laxity

Interventions

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

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-08-18
• Completion: 2016-08-18
• First posted: 2015-05-12
• Last updated: 2019-02-20
• Results posted: 2019-02-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study