NCT01708447

Feasibility Study: Evaluate the Effectiveness of Using a Topical Anesthetic Prior to Ultherapy™ Treatment

Feasibility Study: Evaluation of the Efficacy of a Liposome-encapsulated Lidocaine Topical Anesthetic for Reducing Discomfort Associated With Ultherapy™ Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for reducing discomfort associated with Ultherapy™ treatment.

Detailed description

All subjects will receive a full face and neck Ultherapy™ treatment. Thirty (30) minutes prior to treatment, a topical anesthetic (numbing cream) will be applied to one side of the face and neck and a placebo cream with similar consistency and color will be applied to the other side of the face and neck, in a randomized fashion. The subject and investigator or sub-investigator performing Ultherapy™ treatment will be blinded to the side to which the topical anesthetic is applied. Pain scores will be collected following treatment of each section of the face and neck on both sides. Subjects will return for a 90-day post-treatment visit to assess improvement in skin laxity, and overall lifting and tightening of skin.

Conditions

• Skin Laxity

Interventions

Type	Name	Description
DRUG	L.M.X.4.® cream	A lidocaine topical anesthetic cream
OTHER	A placebo cream	Placebo cream containing no anesthetic properties.
DEVICE	Ulthera System Treatment	Focused ultrasound energy delivered below the surface of the skin

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2012-10-17
• Last updated: 2017-11-24

Locations

1 site across 1 country: United States