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: May 22, 2014
Last verified: May 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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 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 ] [ 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


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

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 5, 2009
Results First Received: February 7, 2012
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014