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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00894244
First Posted: May 6, 2009
Last Update Posted: June 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Murad Alam, Northwestern University
  Purpose
This study is being done to measure the amount of skin shrinkage caused by a non-invasive skin tightening device.

Condition Intervention
Healthy Device: Radiofrequency device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device

Further study details as provided by Murad Alam, Northwestern University:

Primary Outcome Measures:
  • 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


Enrollment: 25
Study Start Date: April 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894244


Locations
United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT00894244     History of Changes
Other Study ID Numbers: STU1178
First Submitted: May 5, 2009
First Posted: May 6, 2009
Results First Submitted: February 7, 2012
Results First Posted: September 3, 2012
Last Update Posted: June 4, 2014
Last Verified: May 2014

Keywords provided by Murad Alam, Northwestern University:
None- Normal healthy upper arm skin will be used.