Back to resultsFeasibility Study: Evaluate the Effectiveness of Using a Topical Anesthetic Prior to Ultherapy™ Treatment
Primary Purpose
Skin Laxity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
L.M.X.4.® cream
A placebo cream
Ulthera System Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Skin Laxity
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.
Sites / Locations
- North Valley Plastic Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Topical anesthetic - L.M.X.4.® cream
Placebo cream
Arm Description
Topical anesthetic cream, L.M.X.4.® cream, applied to one side of the face and neck prior to Ulthera System treatment.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Improvement in skin laxity.
Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01708447
Brief Title
Feasibility Study: Evaluate the Effectiveness of Using a Topical Anesthetic Prior to Ultherapy™ Treatment
Official Title
Feasibility Study: Evaluation of the Efficacy of a Liposome-encapsulated Lidocaine Topical Anesthetic for Reducing Discomfort Associated With Ultherapy™ Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ulthera, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical anesthetic - L.M.X.4.® cream
Arm Type
Active Comparator
Arm Description
Topical anesthetic cream, L.M.X.4.® cream, applied to one side of the face and neck prior to Ulthera System treatment.
Arm Title
Placebo cream
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
L.M.X.4.® cream
Other Intervention Name(s)
A lidocaine topical anesthetic cream
Intervention Description
A lidocaine topical anesthetic cream
Intervention Type
Other
Intervention Name(s)
A placebo cream
Intervention Description
Placebo cream containing no anesthetic properties.
Intervention Type
Device
Intervention Name(s)
Ulthera System Treatment
Other Intervention Name(s)
Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Intervention Description
Focused ultrasound energy delivered below the surface of the skin
Primary Outcome Measure Information:
Title
Treatment-related pain
Description
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.
Time Frame
During treatment
Secondary Outcome Measure Information:
Title
Improvement in skin laxity.
Description
Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs.
Time Frame
90 days post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Gitt, MD
Organizational Affiliation
North Valley Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Valley Plastic Surgery
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study: Evaluate the Effectiveness of Using a Topical Anesthetic Prior to Ultherapy™ Treatment
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