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Study of the Carbon Dioxide Treatment for Fat Reduction

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Murad Alam, Northwestern University Identifier:
First received: September 9, 2009
Last updated: February 7, 2017
Last verified: February 2017
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 Procedure: Sham

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Participant
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 Murad Alam, Northwestern University:

Primary Outcome Measures:
  • Reduction of flank circumference [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 10-point pain visual analog scale [ Time Frame: 4 weeks ]
  • Any adverse events [ Time Frame: 6 months ]
  • Patient satisfaction, determined by using patient satisfaction questionnaires. [ Time Frame: 6 months ]

Estimated Enrollment: 25
Study Start Date: January 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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
Sham Comparator: sham
sham treatment
Procedure: Sham
Sham treatment to other flank at each study visit


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00974415

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Murad Alam, MD Northwestern University
Study Chair: Dennis P West, PhD Northwestern University
  More Information

Responsible Party: Murad Alam, Professor of Dermatology, Northwestern University Identifier: NCT00974415     History of Changes
Other Study ID Numbers: STU11387
Study First Received: September 9, 2009
Last Updated: February 7, 2017

Keywords provided by Murad Alam, Northwestern University:
BMI classification-overweight

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms processed this record on June 23, 2017