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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Skin Laxity

Intervention / Treatment
-----------------
* Drug: L.M.X.4.® cream
* Other: A placebo cream
* Device: Ulthera System Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged 30 to 65 years. Chosen an Ultherapy™ treatment as part of their treatment regimen. Subject in good health. Skin laxity on the face and neck. Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period. Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study Exclusion Criteria: Known sensitivity to lidocaine or any other anesthetic of the amide type. History of anaphylactic shock. Presence of an active systemic or local skin disease that may affect wound healing. Current therapy with class I antiarrhythmic drugs (e.g., tocainide, mexiletine). Known or suspected hypersensitivity to LMX-4 active substance, or any of the amide-type local anaesthetics, or any of the excipients (protocol section 10.3). Severe solar elastosis. Excessive subcutaneous fat in the face and neck. Body mass index of 30 or greater. Excessive skin laxity on the face and neck. Significant scarring in areas to be treated. Significant open facial wounds or lesions. Severe or cystic acne on the face. Presence of a metal stent or implant in the facial area to be treated.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical anesthetic - L.M.X.4.® cream<br>Topical anesthetic cream, L.M.X.4.® cream, applied to one side of the face and neck prior to Ulthera System treatment. | Drug: L.M.X.4.® cream<br>* A lidocaine topical anesthetic cream<br>* Other names: A lidocaine topical anesthetic cream;Device: Ulthera System Treatment<br>* Focused ultrasound energy delivered below the surface of the skin<br>* Other names: Ultrasound treatment for skin tightening;|
| Placebo Comparator: Placebo cream<br>A placebo cream with similar consistency and color will be applied to the other side of the face and neck prior to Ulthera System treatment. | Other: A placebo cream<br>* Placebo cream containing no anesthetic properties.<br>Device: Ulthera System Treatment<br>* Focused ultrasound energy delivered below the surface of the skin<br>* Other names: Ultrasound treatment for skin tightening;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related pain | The validated 10-point pain NRS scale will be used to measure average pain scores reported by subject immediately after each facial region is treated. | During treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in skin laxity. | Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs. | 90 days post-treatment |