MedTrace Logo

Ultherapy® for Treating the Face and Neck Using Standard Versus Simulines Transducers

NCT02416076 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-04-23

No results posted yet for this study

Summary

Up to 40 participants will be enrolled, randomized and treated. Enrolled participants will receive one, split-face Ulthera® treatment on the face and neck using a Ulthera System standard transducer on one side of the face and a Ulthera System prototype simulines transducers on the other side of the face. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Conditions

  • Skin Laxity

Interventions

DEVICE

Ulthera Treatment at EL2

Focused ultrasound energy delivered below the surface of the skin.

DEVICE

Ulthera Treatment at EL4

Focused ultrasound energy delivered below the surface of the skin.

Sponsors & Collaborators

  • Ulthera, Inc

    lead INDUSTRY

Principal Investigators

  • Merz Medical Expert · Merz North America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-12-15
Primary Completion
2015-09-23
Completion
2016-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT02416076 on ClinicalTrials.gov