Subcutaneous Fat Reduction in the Submental Area

Body Fat Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298322
• Other study ID #: ZA14-002
• Status: Completed
• Phase: N/A
• Start date: November 11, 2014
• Est. completion date: August 2, 2015

Study information

• Verified date: September 2020
• Source: Zeltiq Aesthetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Non-invasive treatment for subcutaneous fat reduction in the submental area.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2, 2015
• Est. primary completion date: August 2, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Body Fat Disorder
• Lipid Metabolism Disorders

Intervention

Device:
• CoolSculpting System

Locations

Country	Name	City	State
United States	Zel Skin & Laser Specialists	Edina	Minnesota
United States	EpiCentre Skin and Laser Center	Plano	Texas
United States	Laser & Skin Surgery Center of Northern California	Sacramento	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	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
Primary	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	Change in the Fat Layer of the Treated Area as Measured by Ultrasound	Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Results indicate the fat layer reduction in cm.	12 weeks post-final treatment
Secondary	Subject Satisfaction With CoolScupting in the Submental Area	Subject satisfaction as assessed by questionnaires administered at 12 weeks post-final treatment. The questionnaire will ask the subject about their treatment experience and the efficacy of the treatment.	12 weeks post-final treatment