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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01708447
First received: October 15, 2012
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Skin Laxity
Drug: L.M.X.4.® cream
Other: A placebo cream
Device: Ulthera System Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Feasibility Study: Evaluation of the Efficacy of a Liposome-encapsulated Lidocaine Topical Anesthetic for Reducing Discomfort Associated With Ultherapy™ Treatment

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Treatment-related pain [ Time Frame: During treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Improvement in skin laxity. [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
    Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs.


Enrollment: 16
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: L.M.X.4.® cream
A lidocaine topical anesthetic cream
Other Name: A lidocaine topical anesthetic cream
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Names:
  • Ulthera® System
  • Ultherapy™ Treatment
  • Ulthera, Inc.
  • Ultrasound treatment for skin tightening
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.
Other: A placebo cream
Placebo cream containing no anesthetic properties.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Names:
  • Ulthera® System
  • Ultherapy™ Treatment
  • Ulthera, Inc.
  • Ultrasound treatment for skin tightening

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708447

Locations
United States, Arizona
North Valley Plastic Surgery
Phoenix, Arizona, United States, 85050
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Steven Gitt, MD North Valley Plastic Surgery
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01708447     History of Changes
Other Study ID Numbers: ULT-117
Study First Received: October 15, 2012
Last Updated: June 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases
Anesthetics
Lidocaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014