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

Ulthera

Status: Completed

Conditions: Skin Laxity

Treatments: Other: A placebo cream; Device: Ulthera System Treatment; Drug: L.M.X.4.® cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT01708447

ULT-117

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

Topical anesthetic - L.M.X.4.® cream

Active Comparator group

Description:

Topical anesthetic cream, L.M.X.4.® cream, applied to one side of the face and neck prior to Ulthera System treatment.

Treatment:

Drug: L.M.X.4.® cream

Device: Ulthera System Treatment

Placebo cream

Placebo Comparator group

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.

Treatment:

Other: A placebo cream

Device: Ulthera System Treatment