Subcutaneous Fat Reduction in the Submental Area

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Body Fat Disorder

Intervention / Treatment
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* Device: CoolSculpting System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CoolSculpting Treatment<br>The intervention is the CoolSculpting System. | Device: CoolSculpting System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |