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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Withdrawn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
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Laxity

Eligibility Criteria

35 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    November 5, 2012
    Last Updated
    December 2, 2021
    Sponsor
    Northwestern University
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    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    Withdrawn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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