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

Skin Laxity Clinical Trial

Official title:

Feasibility Study: Evaluation of the Efficacy of a Liposome-encapsulated Lidocaine Topical Anesthetic for Reducing Discomfort Associated With Ultherapy™ Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708447
• Other study ID #: ULT-117
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: November 21, 2017
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: June 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

Drug:
• L.M.X.4.® cream
A lidocaine topical anesthetic cream

Other:
• A placebo cream
Placebo cream containing no anesthetic properties.

Device:
• Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin

Locations

Country	Name	City	State
United States	North Valley Plastic Surgery	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-related pain	The validated 10-point pain NRS scale will be used to measure average pain scores reported by subject immediately after each facial region is treated.	During treatment
Secondary	Improvement in skin laxity.	Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs.	90 days post-treatment