Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device

December 1, 2021 updated by: Murad Alam, Northwestern University
This study is being done to measure the amount of skin shrinkage caused by a non-invasive skin tightening device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine, Department of Dermatology

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

26 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 30-60 y/o
  • Mild to moderate laxity of arm skin
  • Skin of Fitzpatrick levels I-III

Exclusion Criteria:

  • Any active local arm infections
  • Scarring or abnormalities in upper arm area
  • Major systemic illnesses
  • Any condition with delayed wound healing
  • History of psychiatrist illnesses

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Treatment using a non-invasive skin tightening radiofrequency device to observe skin shrinkage in the arms
Device: Radiofrequency device
One treatment pass on one arm. 2-5 treatment passes on the other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in Skin Tightening in the Upper Inner or Outer Arm (as Measured by Millimeters)
Time Frame: immediately following treatment and 30 days after last treatment
The documented variable was shrinkage length in millimeters as measured by the same straight ruler used throughout the experimentation. Measurements were taken immediately following treatment and thirty days following the last treatment
immediately following treatment and 30 days after last treatment

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

April 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

May 5, 2009

First Submitted That Met QC Criteria

May 5, 2009

First Posted (Estimate)

May 6, 2009

Study Record Updates

Last Update Posted (Actual)

December 28, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STU1178

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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