Pilot Study on the Submental Area

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

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

Study Overview

• Status: Completed
• Conditions: Body Fat Disorder
• Intervention / Treatment: Device: The Zeltiq System

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pleasanton, California, United States, 94588
      • Innovation Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fat Reduction	Device: The Zeltiq System; Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.; Other Names: Cryolipolysis; Lipolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Zeltiq Aesthetics

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: May 16, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (Estimate): May 21, 2013

Study Record Updates

• Last Update Posted (Estimate): October 16, 2014
• Last Update Submitted That Met QC Criteria: October 14, 2014
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Lipolysis; Cryolipolysis; Fat Reduction
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: ZA13-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No