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

NCT01708447 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-11-24

No results posted yet for this study

Summary

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

Conditions

  • Skin Laxity

Interventions

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

Sponsors & Collaborators

  • Ulthera, Inc

    lead INDUSTRY

Principal Investigators

  • Steven Gitt, MD · North Valley Plastic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-12-31
Completion
2012-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01708447 on ClinicalTrials.gov