Study of the Carbon Dioxide Treatment for Fat Reduction

NCT ID: NCT00974415

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2025-12-31

Brief Summary

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

Conditions

Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

treatment

CO2 treatment

Group Type: EXPERIMENTAL

CO2

Intervention Type: PROCEDURE

CO2 treatment delivered to randomized flank at each study visit

sham

sham treatment

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: PROCEDURE

Sham treatment to other flank at each study visit

Interventions

CO2

CO2 treatment delivered to randomized flank at each study visit

Intervention Type: PROCEDURE

Sham

Sham treatment to other flank at each study visit

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Murad Alam

Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU11387

Identifier Type: -

Identifier Source: org_study_id