Study of the Carbon Dioxide Treatment for Fat Reduction

Sponsor
Northwestern University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00974415
Collaborator
(none)
25
1
2
155
0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: CO2
  • Procedure: Sham
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of the Carbon Dioxide Treatment for Fat Reduction
Study Start Date :
Jan 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Reduction of flank circumference [6 months]

Secondary Outcome Measures

  1. 10-point pain visual analog scale [4 weeks]

  2. Any adverse events [6 months]

  3. Patient satisfaction, determined by using patient satisfaction questionnaires. [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
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

Locations

Site City State Country Postal Code
1 Northwestern University Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: Murad Alam, MD, Northwestern University
  • Study Chair: Dennis P West, PhD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Murad Alam, Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier:
NCT00974415
Other Study ID Numbers:
  • STU11387
First Posted:
Sep 10, 2009
Last Update Posted:
Jan 5, 2022
Last Verified:
Jan 1, 2022
Keywords provided by Murad Alam, Professor of Dermatology, Northwestern University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 5, 2022