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

NCT ID: NCT01708447

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Skin Laxity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

L.M.X.4.® cream

Intervention Type DRUG

A lidocaine topical anesthetic cream

Ulthera System Treatment

Intervention Type DEVICE

Focused ultrasound energy delivered below the surface of the skin

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.

Group Type PLACEBO_COMPARATOR

A placebo cream

Intervention Type OTHER

Placebo cream containing no anesthetic properties.

Ulthera System Treatment

Intervention Type DEVICE

Focused ultrasound energy delivered below the surface of the skin

Interventions

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L.M.X.4.® cream

A lidocaine topical anesthetic cream

Intervention Type DRUG

A placebo cream

Placebo cream containing no anesthetic properties.

Intervention Type OTHER

Ulthera System Treatment

Focused ultrasound energy delivered below the surface of the skin

Intervention Type DEVICE

Other Intervention Names

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A lidocaine topical anesthetic cream Ulthera® System Ultherapy™ Treatment Ulthera, Inc. Ultrasound treatment for skin tightening

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ulthera, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Gitt, MD

Role: PRINCIPAL_INVESTIGATOR

North Valley Plastic Surgery

Locations

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North Valley Plastic Surgery

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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ULT-117

Identifier Type: -

Identifier Source: org_study_id