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

NCT01708447 | Completed

• 1 other identifier: ULT-117
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Laxity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement in skin laxity.

  90 days post-treatment

Study Arms (2)

Topical anesthetic - L.M.X.4.® cream

ACTIVE COMPARATOR

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; Device: Ulthera System Treatment

Placebo cream

PLACEBO COMPARATOR

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; Device: Ulthera System Treatment

Interventions

L.M.X.4.® cream DRUG

A lidocaine topical anesthetic cream

Also known as: A lidocaine topical anesthetic cream

Topical anesthetic - L.M.X.4.® cream

A placebo cream OTHER

Placebo cream containing no anesthetic properties.

Placebo cream

Ulthera System Treatment DEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening

Placebo cream; Topical anesthetic - L.M.X.4.® cream

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

North Valley Plastic Surgery

Phoenix, Arizona, 85050, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Steven Gitt, MD

  North Valley Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 17, 2012
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: November 24, 2017

Record last verified: 2013-06

Locations

US (1)