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NCT03351335 · ClinicalTrials.gov registry record · NA

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

A NA study of Mild to Moderate Skin Laxity Under the Chin and Mild to Moderate Skin Laxity on Neck, sponsored by Merz North America.

Completed
Registry status
NA
Development phase
60
Enrollment target
7
Study locations

NCT03351335: Completed NA study of Mild to Moderate Skin Laxity Under the Chin and Mild to Moderate Skin Laxity on Neck, sponsored by Merz North America.

NCT03351335 is a NA study of Mild to Moderate Skin Laxity Under the Chin and Mild to Moderate Skin Laxity on Neck that has completed, run by Merz North America. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03351335, a NA study of Mild to Moderate Skin Laxity Under the Chin and Mild to Moderate Skin Laxity on Neck, has completed, sponsored by Merz North America.

COMPLETED
Registry status
NA
Development phase
60 participants
Enrollment target
7
Study locations

Study Summary

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

Primary Outcome

Lifting was determined by a quantitative measure of tissue lift in the area using photographs taken with Mirror Photofile software and a Vectra 3 dimensional (3D) digital imaging system. Mean change was calculated as mean of left and right side 90 day area minus mean of left and right baseline area.

Interventions

  • DEVICE Microfocused ultrasound with visualization

Study Locations (7)

Texas

  • Merz Investigational Site # 0010410 - Austin
  • Merz Investigational Site # 0010422 - Bellaire
  • Merz Investigational Site # 0010423 - Houston
  • Merz Investigational Site # 0010125 - Plano

California

  • Merz Investigational Site # 0010411 - Los Gatos
  • Merz Investigational Site # 0010321 - San Diego
  • Merz Investigational Site # 0010358 - Vista

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2017-08-10
Est. Completion 2018-08-09
Phase NA
Merz North America

35 total trials

What the finished NCT03351335 record still lists

NCT03351335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 2 conditions, with Mild to Moderate Skin Laxity Under the Chin appearing as the primary indexed condition, and to 1 intervention - of which Microfocused ultrasound with visualization is the first listed.

NCT03351335 lists 7 locations in 2 states (Texas, California).

Frequently Asked Questions

What is clinical trial NCT03351335 about?

NCT03351335 is a clinical study titled "Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) and Neck Tissue in Chinese Patients". To evaluate the Ulthera® System for lifting submental (under the chin) and neck tissue in Chinese patients

What is the current status of trial NCT03351335?

This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2017-08-10. Estimated completion is 2018-08-09.

What conditions does trial NCT03351335 study?

This clinical trial studies the following conditions: Mild to Moderate Skin Laxity Under the Chin, Mild to Moderate Skin Laxity on Neck.

What interventions are being tested in trial NCT03351335?

The interventions under investigation include: Microfocused ultrasound with visualization (DEVICE).

Who is sponsoring clinical trial NCT03351335?

This trial is sponsored by Merz North America, which has 35 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03351335 being conducted?

This trial has 7 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03351335's enrollment target sits among peer trials

60 1164th of 2000 higher than 745 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03351335, the US trial registry maintained by the National Library of Medicine. NCT03351335 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.