MedTrace Logo

Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck

NCT07614997 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2026-05-29

No results posted yet for this study

Summary

The purpose of this study is to demonstrate superiority of treatment with the Ulthera System compared to untreated control for the improvement of skin laxity of the lower face, submental area and neck and to demonstrate the safety of treatment with the Ulthera System for the improvement of skin laxity of the lower face, submental area and neck.

Conditions

  • Cutis Laxa

Interventions

DEVICE

Ulthera System

Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.

Sponsors & Collaborators

  • Ulthera, Inc

    collaborator INDUSTRY

  • Merz North America, 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
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-12-31
Completion
2027-03-31

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 NCT07614997 on ClinicalTrials.gov