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

October 15, 2012
June 27, 2013
July 2011
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01708447 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Skin Laxity
  • Drug: L.M.X.4.® cream
    A lidocaine topical anesthetic cream
    Other Name: 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
    Other Names:
    • Ulthera® System
    • Ultherapy™ Treatment
    • Ulthera, Inc.
    • Ultrasound treatment for skin tightening
  • 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.
    Interventions:
    • Drug: L.M.X.4.® cream
    • Device: Ulthera System Treatment
  • 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.
    Interventions:
    • Other: A placebo cream
    • Device: Ulthera System Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
January 2012
December 2011   (final data collection date for primary outcome measure)

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.
Both
30 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01708447
ULT-117
No
Ulthera, Inc
Ulthera, Inc
Not Provided
Principal Investigator: Steven Gitt, MD North Valley Plastic Surgery
Ulthera, Inc
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP