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

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

Study Overview

• Status: Completed
• Conditions: Skin Laxity
• Intervention / Treatment: Device: Ulthera System Treatment; Drug: L.M.X.4.® cream; Other: A placebo cream

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85050
      • North Valley Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Topical anesthetic - L.M.X.4.® cream; Topical anesthetic cream, L.M.X.4.® cream, applied to one side of the face and neck prior to Ulthera System treatment.	Device: Ulthera System Treatment; Focused ultrasound energy delivered below the surface of the skin; Other Names: Ulthera, Inc.; Ultrasound treatment for skin tightening; Ulthera® System; Ultherapy™ Treatment; Drug: L.M.X.4.® cream; A lidocaine topical anesthetic cream; Other Names: A lidocaine topical anesthetic cream
Placebo Comparator: Placebo cream; 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.	Device: Ulthera System Treatment; Focused ultrasound energy delivered below the surface of the skin; Other Names: Ulthera, Inc.; Ultrasound treatment for skin tightening; Ulthera® System; Ultherapy™ Treatment; Other: A placebo cream; Placebo cream containing no anesthetic properties.

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

Collaborators and Investigators

• Sponsor: Ulthera, Inc
• Investigators: Principal Investigator: Steven Gitt, MD, North Valley Plastic Surgery

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 15, 2012
• First Submitted That Met QC Criteria: October 16, 2012
• First Posted (Estimate): October 17, 2012

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Membrane Transport Modulators; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics; Lidocaine; Anesthetics, Local
• Other Study ID Numbers: ULT-117