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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ulthera, Inc
• Treatments: Anesthetics; Anesthetics, Local; Lidocaine

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.