Fat Reduction in the Submandibular/Submental Area

NCT02700165 | Completed Results FDA Device

• 1 other identifier: ZA15-006
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Proportion of Accurately Identified Pre-Treatment Photos by a Panel of Blinded Independent Reviewers

  Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Success is defined as 70% correct identification of pre-treatment images by at least 70% correct identification of pre-treatment images by two out of three reviewers.

  Baseline (pre-treatment) and 12 weeks post treatment

• The Number of Unanticipated Adverse Device Effects (UADE) Reported

  The primary safety endpoint is the count of unanticipated adverse device effects (UADEs) reported in the study period. It is expected there will be zero UADEs.

  Enrollment through the 12 week final follow-up visit

Secondary Outcomes (2)

• Change in Fat Layer Thickness of the Submental Area as Measured by Caliper

  Baseline and 12 week post-treatment

• Subject Satisfaction

  12 weeks post-treatment

Study Arms (1)

CoolSculpting with CoolMini

EXPERIMENTAL

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

Device: The ZELTIQ CoolSculpting System

Interventions

The ZELTIQ CoolSculpting System DEVICE

The CoolSculpting device will be used to perform the treatments.

CoolSculpting with CoolMini

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeltiq Aesthetics: lead

Study Sites (1)

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, 19003, United States

Location

Related Publications (1)

• 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.

  PMID: 28426847 BACKGROUND

Results Point of Contact

• Title: Kerrie Jiang, Exective Director, Regulatory, Clinical and Medical Affairs
• Organization: Zeltiq Aesthetics

Kerrie.Jiang@allergan.com

(925) 621-7462

Study Officials

• Eric Bernstein, MD

  Main Line Center for Laser Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: March 7, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 16, 2021
• Results First Posted: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)