Clinical trial NCT01708447: 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
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-17
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Treatment-related pain
timeFrame: During treatment
Secondary outcomes:
measure: Improvement in skin laxity.
timeFrame: 90 days post-treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: North Valley Plastic Surgery
state: Arizona
Study officials:
affiliation: North Valley Plastic Surgery
name: Steven Gitt, MD
role: PRINCIPAL_INVESTIGATOR
References: