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Combination of Ultrasound Treatment and Neck Liposuction for Skin Tightening

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01735929
First Posted: November 28, 2012
Last Update Posted: June 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Murad Alam, Northwestern University
  Purpose
The purpose of this study is to find out the effectiveness of ultrasound treatment and liposuction combined on skin tightening around the neck.

Condition Intervention
Skin Laxity Procedure: Neck Liposuction and Ultrasound Treatment Procedure: Sham Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Combined Skin Tightening Benefit of Non-Invasive Ultrasound Treatment and Neck Liposuction

Resource links provided by NLM:


Further study details as provided by Murad Alam, Northwestern University:

Primary Outcome Measures:
  • Change from baseline in photo ratings at 8 weeks. [ Time Frame: Baseline and 8 weeks ]
    Two blinded raters will compare baseline and 8 week photos of subjects that received the combined treatments or the sham treatments.


Enrollment: 0
Study Start Date: March 2016
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neck Liposuction and Ultrasound Treatment
Subject will receive neck liposuction and ultrasound treatment.
Procedure: Neck Liposuction and Ultrasound Treatment
Sham Comparator: Sham
Subject will receive sham treatment
Procedure: Sham Treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735929


Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT01735929     History of Changes
Other Study ID Numbers: STU68167
First Submitted: November 5, 2012
First Posted: November 28, 2012
Last Update Posted: June 28, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases