Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device
This study has been completed.
Sponsor:
Northwestern University
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
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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
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: | September 14, 2012 |
| 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 May 16, 2013