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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00894244
First received: May 5, 2009
Last updated: September 14, 2012
Last verified: September 2012
History of Changes

May 5, 2009
September 14, 2012
April 2009
September 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
The degree of skin tightening in the upper inner or outer arm [ Time Frame: 30 days after last treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00894244 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device
Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device

This study is being done to measure the amount of skin shrinkage caused by a non-invasive skin tightening device.
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Healthy
Device: Radiofrequency device
One treatment pass on one arm. 2-5 treatment passes on the other
Experimental: Treatment
Treatment using a non-invasive skin tightening radiofrequency device to observe skin shrinkage in the arms
Intervention: Device: Radiofrequency device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
30 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00894244
STU1178
No
Murad Alam, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Murad Alam, MD Northwestern University
Northwestern University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP