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Completed

NCT Number: NCT01708447

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

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

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Key information

Conditions

Skin Laxity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Valley Plastic Surgery

Phoenix, Arizona, 85050, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L.M.X.4.® cream

Drug

A lidocaine topical anesthetic cream

Other names: A lidocaine topical anesthetic cream

A placebo cream

Other

Placebo cream containing no anesthetic properties.

Ulthera System Treatment

Device

Focused ultrasound energy delivered below the surface of the skin

Other names: Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening

Primary outcomes

  1. Treatment-related pain

    Time frame: During treatment

    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.

Secondary outcomes

  1. Improvement in skin laxity.

    Time frame: 90 days post-treatment

    Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs.

Sponsors and collaborators

Lead sponsor

Ulthera, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Oct 17, 2012
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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