Subcutaneous Fat Reduction in the Submental Area

NCT02298322 | Completed Results FDA Device

• 1 other identifier: ZA14-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area using Cryolipolysis. Healthy adult men and women with submental skin fold thickness \> 1cm who desire reduction of submental fat.

Conditions

Body Fat Disorder

Outcome Measures

Primary Outcomes (2)

• Safety of CoolScupting in the Submental Area

  Safety of the Zeltiq CoolSculpting device will be assessed by measuring the incidence of device- and/or procedure-related adverse events. Adverse event reports are collected from the time of enrollment through the 12 week follow-up visit.

  Time of enrollment through12 week post-final treatment follow-up

• Percentage of Correct Identification of Pre-treatment Photographs

  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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure.

  12 week post-final-treatment

Secondary Outcomes (2)

• Change in the Fat Layer of the Treated Area as Measured by Ultrasound

  12 weeks post-final treatment

• Subject Satisfaction With CoolScupting in the Submental Area

  12 weeks post-final treatment

Study Arms (1)

CoolSculpting Treatment

EXPERIMENTAL

The intervention is the CoolSculpting System.

Device: CoolSculpting System

Interventions

CoolSculpting System DEVICE

CoolSculpting Treatment

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 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 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, 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 (3)

Laser & Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

Zel Skin & Laser Specialists

Edina, Minnesota, 55424, United States

Location

EpiCentre Skin and Laser Center

Plano, Texas, 75024, United States

Location

Results Point of Contact

• Title: Kerrie Jiang, Executive Director, Regulatory, Clinical and Medical Affairs
• Organization: Zeltiq Aesthetics, Inc. an Allergan Affiliate

Kerrie.Jiang@allergan.com

(925) 621-7462

Study Officials

• Lori Brandt, BSN

  Zeltiq Aesthetics

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 21, 2014
• Study Start: November 11, 2014
• Primary Completion: August 2, 2015
• Study Completion: August 2, 2015
• Last Updated: September 24, 2020
• Results First Posted: September 24, 2020

Record last verified: 2020-09

Locations

US (3)