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Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) and Neck Tissue in Chinese Patients

NCT03351335 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-08-28

Study results available
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Summary

To evaluate the Ulthera® System for lifting submental (under the chin) and neck tissue in Chinese patients

Conditions

  • Mild to Moderate Skin Laxity Under the Chin
  • Mild to Moderate Skin Laxity on Neck

Interventions

DEVICE

Microfocused ultrasound with visualization

All subjects will receive an Ultherapy® treatment at dual depth using the 4-4.5mm and 7-3.0mm transducers. Treatments will be provided to the lower face, submental (under the chin) and neck area.

Sponsors & Collaborators

  • Ulthera, Inc

    collaborator INDUSTRY

  • Merz North America, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter Kreymerman, MD, FA · Merz North America, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-10
Primary Completion
2018-08-09
Completion
2018-08-09
FDA Device
Yes

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 NCT03351335 on ClinicalTrials.gov