Combination of Ultrasound Treatment and Neck Liposuction for Skin Tightening
Primary Purpose
Skin Laxity
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neck Liposuction and Ultrasound Treatment
Sham Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Skin Laxity
Eligibility Criteria
Inclusion Criteria:
- Women 35-60 years old
- Exhibit mild to moderate neck skin laxity on clinical examination
- No other serious health problems, including psychiatric illness.
Exclusion Criteria:
- Prior neck surgery or face lift.
- Bleeding disorders or coagulopathy.
- Botulinum toxin or filler injections to neck area within past 6 months.
- Severe neck skin laxity or sagging
- Other serious medical conditions that in the opinion of the surgeon could compromise safety
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Neck Liposuction and Ultrasound Treatment
Sham
Arm Description
Subject will receive neck liposuction and ultrasound treatment.
Subject will receive sham treatment
Outcomes
Primary Outcome Measures
Change from baseline in photo ratings at 8 weeks.
Two blinded raters will compare baseline and 8 week photos of subjects that received the combined treatments or the sham treatments.
Secondary Outcome Measures
Full Information
NCT ID
NCT01735929
First Posted
November 5, 2012
Last Updated
December 2, 2021
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT01735929
Brief Title
Combination of Ultrasound Treatment and Neck Liposuction for Skin Tightening
Official Title
Evaluating the Combined Skin Tightening Benefit of Non-Invasive Ultrasound Treatment and Neck Liposuction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Study Start Date
March 2016 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to find out the effectiveness of ultrasound treatment and liposuction combined on skin tightening around the neck.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neck Liposuction and Ultrasound Treatment
Arm Type
Experimental
Arm Description
Subject will receive neck liposuction and ultrasound treatment.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Subject will receive sham treatment
Intervention Type
Procedure
Intervention Name(s)
Neck Liposuction and Ultrasound Treatment
Intervention Type
Procedure
Intervention Name(s)
Sham Treatment
Primary Outcome Measure Information:
Title
Change from baseline in photo ratings at 8 weeks.
Description
Two blinded raters will compare baseline and 8 week photos of subjects that received the combined treatments or the sham treatments.
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women 35-60 years old
Exhibit mild to moderate neck skin laxity on clinical examination
No other serious health problems, including psychiatric illness.
Exclusion Criteria:
Prior neck surgery or face lift.
Bleeding disorders or coagulopathy.
Botulinum toxin or filler injections to neck area within past 6 months.
Severe neck skin laxity or sagging
Other serious medical conditions that in the opinion of the surgeon could compromise safety
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Combination of Ultrasound Treatment and Neck Liposuction for Skin Tightening
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