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Combination of Ultrasound Treatment and Neck Liposuction for Skin Tightening

This study is currently recruiting participants.
Verified November 2012 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01735929
First received: November 5, 2012
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change from baseline in photo ratings at 8 weeks. [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Two blinded raters will compare baseline and 8 week photos of subjects that received the combined treatments or the sham treatments.


Estimated Enrollment: 36
Study Start Date: October 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (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

Ages Eligible for Study:   35 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735929

Contacts
Contact: Emily Poon, PhD 312-695-4761 research.nuderm@northwestern.edu

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology Recruiting
Chicago, Illinois, United States, 60611
Contact: Emily Poon, PhD     312-695-4761     research.nuderm@northwestern.edu    
Principal Investigator: Murad Alam, MD            
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: NCT01735929     History of Changes
Other Study ID Numbers: STU68167
Study First Received: November 5, 2012
Last Updated: November 21, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013