Combination of Ultrasound Treatment and Neck Liposuction for Skin Tightening

December 2, 2021 updated by: Murad Alam, Northwestern University

Evaluating the Combined Skin Tightening Benefit of Non-Invasive Ultrasound Treatment and Neck Liposuction

The purpose of this study is to find out the effectiveness of ultrasound treatment and liposuction combined on skin tightening around the neck.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women 35-60 years old
  • Exhibit mild to moderate neck skin laxity on clinical examination
  • No other serious health problems, including psychiatric illness.

Exclusion Criteria:

  • Prior neck surgery or face lift.
  • Bleeding disorders or coagulopathy.
  • Botulinum toxin or filler injections to neck area within past 6 months.
  • Severe neck skin laxity or sagging
  • Other serious medical conditions that in the opinion of the surgeon could compromise safety

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neck Liposuction and Ultrasound Treatment
Subject will receive neck liposuction and ultrasound treatment.
Procedure: Neck Liposuction and Ultrasound Treatment
Sham Comparator: Sham
Subject will receive sham treatment
Procedure: Sham Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in photo ratings at 8 weeks.
Time Frame: Baseline and 8 weeks
Two blinded raters will compare baseline and 8 week photos of subjects that received the combined treatments or the sham treatments.
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

November 21, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Actual)

December 6, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU68167

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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