Pilot Study on the Submental Area

Body Fat Disorder Clinical Trial

Official title:

Pilot Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area Using Cryolipolysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859091
• Other study ID #: ZA13-004
• Status: Completed
• Phase: N/A
• First received: May 16, 2013
• Last updated: October 14, 2014
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2013
• Source: Zeltiq Aesthetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and feasibility of cryolipolysis for non-invasive reduction of submental fat.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria

1. Male or female subjects > 18 years of age and < 65 years of age.

2. Presence of submental fat, which in the investigator's opinion, may benefit from the treatment.

3. No weight change exceeding 10 pounds in the preceding month.

4. Agreement to maintain his/her weight (i.e., within 10 pounds) by not making any major changes in their diet or lifestyle during the course of the study.

5. Subject has signed a written informed consent form.

Exclusion Criteria

1. Skin laxity in the neck or chin area for which reduction in submental fat may.

2. Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat.

3. Enlargement on the anterior neck that may prevent the proper placement of the applicator.

4. Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area.

5. Botulinum toxin injections within the neck or chin area.

6. History of a fat reduction procedure in the area of intended treatment.

7. History of prior surgery in the area of intended treatment.

8. Current dental infection.

9. Known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.

10. Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.

11. Impaired skin sensation or thermal sensitivity in the intended treatment area.

12. Open or infected wounds in the intended treatment area.

13. Currently taking or has taken diet pills or weight control supplements within the past month.

14. Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.

15. Active implanted device such as a pacemaker, defibrillator, or drug delivery system.

16. Pregnant or intending to become pregnant in the next 5 months.

17. Lactating or has been lactating in the past 6 months.

18. Unable or unwilling to comply with the study requirements.

19. Currently enrolled in a clinical study of any other unapproved investigational drug or device.

20. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Related Conditions & MeSH terms

• Body Fat Disorder
• Lipid Metabolism Disorders

Intervention

Device:
• The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Locations

Country	Name	City	State
United States	Innovation Research Center	Pleasanton	California

Sponsors (1)

Lead Sponsor	Collaborator
Zeltiq Aesthetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate safety of treatment times	The primary objective of this study is to evaluate the safety of submental fat reduction with the ZELTIQ System. Safety is defined as incidence of device- and/or procedure-related adverse events.	8-weeks post treatment
Secondary	Reduction measured by ultrasound	Percent reduction in fat layer thickness in the treated areas, as measured by ultrasound, at 8 weeks post-treatment.	8-weeks post treatment
Secondary	Photo Review	Comparison of pre- and 8-week post-treatment photographs to assess visible changes in contour in the treated areas.	8-weeks post treatment