Submental Study (Sequential Treatment Approach)
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Intervention: The ZELTIQ CoolSculpting System; Kybella 20 MG in 2 ML Injection
Intervention description: The CoolSculpting machine will be used to perform the treatments.; Injectable drug called KYBELLA® (deoxycholic acid)
Intervention MeSH terms: Deoxycholic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Intervention model description: Kybella and Zeltiq CoolSculpting CoolMini
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 22 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evaluate the safety and efficacy of subcutaneous fat layer reduction in the submental area
      using multiple therapeutic tools.
    

Eligibility criteria:

        Inclusion Criteria

          -  Male or female subjects > 22 years of age and < 65 years of age.

          -  Women of childbearing potential must have a negative urine pregnancy test result at
             screening and agree to practice adequate contraception.

          -  CR-SMFRS grade of 4 (extreme) as determined by the evaluating investigator at
             screening.

          -  Dissatisfaction with the submental area expressed by the subject as a rating of 0, 1
             or 2 using the Subject Self Rating Scale (SSRS) as determined at Screening visit.

          -  History of stable body weight confirmed by the subject, for at least 6 months prior to
             the first treatment session.

          -  Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major
             changes in their diet or exercise routine during the course of the study.

          -  Subject agrees to forgo any treatment or behavior (e.g., unshaven facial hair) during
             the subject's participation in the study that may affect the assessments of the
             submental area.

          -  Subject is medically able to undergo the administration of KYBELLA® determined after
             review of the subject's medical history for which the evaluating investigator
             identifies no clinically significant abnormality.

          -  Subject has read and signed the study written informed consent form.

        Exclusion Criteria

          -  Body Mass Index ≥40 as determined at screening.

          -  Subject has excessive skin laxity, as determined by the evaluating investigator, in
             the neck or chin area or other anatomical feature (e.g., predominant subplatysmal fat,
             loose skin in the neck or chin area, prominent platysmal bands) for which reduction in
             the submental fat may result in an aesthetically unacceptable outcome.

          -  There is evidence of any cause of enlargement in the submental area (e.g., thyroid
             enlargement, cervical adenopathy) other than localized submental fat.

          -  Subject has a history of trauma associated with the chin or neck areas, which in the
             judgement of the investigator may affect evaluation of safety or efficacy of
             treatment.

          -  Subject has a history of treatment with CoolSculpting or KYBELLA® in the intended
             treatment area or has a history of any intervention to treat submental fat (e.g.,
             liposuction, surgery, or lipolytic agents).

          -  Subject has a history of treatment with radiofrequency, micro-focused ultrasound,
             laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12
             months before the first treatment session.

          -  Subject has a history of treatment with botulinum toxin injections in the neck or chin
             area within 6 months before the first treatment session.

          -  Subject has a known history of cryoglobulinemia, cold urticaria, paroxysmal cold
             hemoglobinuria or cold agglutinin disease.

          -  Subject has a known history of Raynaud's disease, or any known condition with a
             response to cold exposure that limits blood flow to the skin.

          -  Subject has a history of facial nerve paresis or paralysis (such as Bell's palsy)

          -  Subject has a history or current symptoms of dysphagia.

          -  Subject has a history of prior neck surgery, or prior surgery in the area of intended
             treatment, or implant in or adjacent to the area of intended treatment.

          -  Subject has a history of sensitivity to any components of the KYBELLA® or to topical
             or local anesthetics (e.g., lidocaine, benzocaine, novocaine).

          -  Subject has a history of bleeding disorder or is taking any medication that in the
             investigator's opinion may increase the subject's risk of bruising.

          -  Subject is currently taking or has taken diet pills or weight control supplements
             within the past month.

          -  Subject has any dermatological conditions, such as scars in the location of the
             treatment area that may interfere with the treatment or evaluation.

          -  Subject has an active implanted device such as a pacemaker, defibrillator, or drug
             delivery system.

          -  Women of childbearing potential not using a reliable means of contraception.

          -  Subject is unable or unwilling to comply with the study requirements.

          -  Subject has received treatment with an investigational device or agent within 30 days
             before the subject's first treatment session.

          -  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.