Study of the Carbon Dioxide Treatment for Fat Reduction

NCT00974415 | Active Not Recruiting

• 1 other identifier: STU11387
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

BMI classification-overweight

Outcome Measures

Primary Outcomes (1)

• Reduction of flank circumference

  6 months

Secondary Outcomes (3)

• 10-point pain visual analog scale

  4 weeks

• Any adverse events

  6 months

• Patient satisfaction, determined by using patient satisfaction questionnaires.

  6 months

Study Arms (2)

treatment

EXPERIMENTAL

CO2 treatment

Procedure: CO2

sham

SHAM COMPARATOR

sham treatment

Procedure: Sham

Interventions

CO2 PROCEDURE

CO2 treatment delivered to randomized flank at each study visit

treatment

Sham PROCEDURE

Sham treatment to other flank at each study visit

sham

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Overweight

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 10, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

US (1)