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

Completed · Not applicable · Has a placebo group

Conditions studied: Skin Laxity

In brief

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

Key facts

Study ID

NCT01708447

Run by

Ulthera, Inc

People needed

16

Starts

2011-07-01

Expected to finish

2012-01-01

Last updated by the study team

2017-11-24

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• North Valley Plastic Surgery — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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