Study of the Carbon Dioxide Treatment for Fat Reduction

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00974415
First received: September 9, 2009
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

The primary objective of this study is to demonstrate the efficacy and safety of the carbon dioxide for subcutaneous fat reduction.


Condition Intervention
Overweight
Procedure: CO2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of the Carbon Dioxide Treatment for Fat Reduction

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Reduction of flank circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 10-point pain visual analog scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Any adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Patient satisfaction, determined by using patient satisfaction questionnaires. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: January 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment
CO2 treatment
Procedure: CO2
CO2 treatment delivered to randomized flank at each study visit

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Male or female subject ages ≥ 18 years old
  • Body mass index (BMI) between 18.5-24.99. (BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches).

Subject in good health

  • Willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation.
  • Subject agrees to maintain their weight (i.e. within 5 pounds) by not making any changes to diet or lifestyle during the study.
  • The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator

Exclusion criteria:

  • Pregnant or lactating or intends to become pregnant in the next 9 months.
  • Unable to understand the protocol or to give informed consent
  • Any previous and/or pending procedures at the treatment area or that may likely affect the treatment area
  • Pending and/or anticipated major change in diet or exercise pattern in the six weeks following the last treatment or who has taken diet pills within the last 6 months.
  • History of asthma or chronic obstructive pulmonary diseases
  • Active skin disease or skin infection in the treatment area
  • Bleeding tendency or coagulopathy
  • Subject who are allergic to lidocaine
  • Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974415

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

Locations
United States, Illinois
Northwestern University 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
Study Chair: Dennis P West, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Murad Alam, Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT00974415     History of Changes
Other Study ID Numbers: STU11387
Study First Received: September 9, 2009
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
BMI classification-overweight

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014