Fat Reduction in the Submandibular/Submental Area

NCT ID: NCT02700165

Last Updated: 2021-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-12-31

Brief Summary

The purpose of this study is to further evaluate the safety and efficacy of non-invasive reduction of subcutaneous fat in the submental and submandibular area using Cryolipolysis.

Conditions

Body Fat Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CoolSculpting with CoolMini

The treatments are designed to see if fat in the submandibular/submental area (chin), can be reduced using cryolipolysis.

Group Type: EXPERIMENTAL

The ZELTIQ CoolSculpting System

Intervention Type: DEVICE

The CoolSculpting device will be used to perform the treatments.

Interventions

The ZELTIQ CoolSculpting System

The CoolSculpting device will be used to perform the treatments.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female subjects > 22 years of age and < 65 years of age.
• Submental and submandibular skin fold thickness > 1cm (measured by caliper).
• No weight change exceeding 5% of body weight in the preceding month.
• Agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
• Subject has signed a written informed consent form.

Exclusion Criteria

• Skin laxity in the neck or chin area for which reduction in submental and submandibular fat may, in the opinion of the investigator, result in an unacceptable aesthetic result.
• Prominent platysmal bands at rest which may interfere with assessment of submental fat
• Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands.
• Significant enlargement on the anterior neck that may prevent the proper placement of the applicator e.g. enlarged thyroid glands.
• Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area (below the mandible) within the past 6 months.
• Botulinum toxin or other aesthetic drug injections within the neck or chin area (below the mandible) within the past 6 months.
• History of facial nerve paresis or paralysis (such as Bell's palsy).
• History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or implant in or adjacent to the area of intended treatment.
• History of prior neck surgery, or prior surgery in the area of intended treatment.
• Current dental infection.
• Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria.
• Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
• History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
• Currently taking or has taken diet pills or weight control supplements within the past month.
• Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
• Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
• Pregnant or intending to become pregnant in the next 6 months.
• Lactating or has been lactating in the past 6 months.
• Unable or unwilling to comply with the study requirements.
• Currently enrolled in a clinical study of an unapproved investigational drug or device.
• 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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zeltiq Aesthetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Bernstein, MD

Role: PRINCIPAL_INVESTIGATOR

Main Line Center for Laser Surgery

Locations

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, United States

Countries

United States

References

Bernstein EF, Bloom JD. Safety and Efficacy of Bilateral Submental Cryolipolysis With Quantified 3-Dimensional Imaging of Fat Reduction and Skin Tightening. JAMA Facial Plast Surg. 2017 Sep 1;19(5):350-357. doi: 10.1001/jamafacial.2017.0102.

Reference Type: BACKGROUND

PMID: 28426847 (View on PubMed)

Other Identifiers

ZA15-006

Identifier Type: -

Identifier Source: org_study_id