Cryolipolysis for Jawline Contouring

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of non-invasive reduction of subcutaneous fat along the jawline with Cryolipolysis.

Official Title
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Non-Invasive Fat Reduction With Cryolipolysis for Jawline Contouring

Conditions
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Body Fat Disorder

Intervention / Treatment
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* Device: The ZELTIQ 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. Treatment area skin fold thickness > 1cm (measured by caliper). Sufficient treatment area requiring at least 2 cooling cycles. 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 Excessive skin laxity in the treatment area for which reduction of subcutaneous 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 treatment area. Evidence of any cause of enlargement in the treatment 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 treatment area (below the mandible) within the past 6 months. Botulinum toxin or other aesthetic drug injections within the treatment area in 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 infection in and adjacent to treatment area. 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.

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: Fat Reduction<br>The treatments are designed to see if the fat can be reduced along the jawline with Cryolipolysis. | Device: The ZELTIQ System<br>* The CoolSculpting machine will be used to perform the treatments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoint in relation to adverse events | Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs | Through study completion, an average of 9-months. | 
| Photo review | Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers. | 12 weeks post second treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness endpoint gauged by reduction in fat layer thickness | Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit. | 12 weeks post second treatment. |