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Cryolipolysis for Jawline Contouring (JAW)

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ClinicalTrials.gov Identifier: NCT03352141
Recruitment Status : Active, not recruiting
First Posted : November 24, 2017
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics

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

Condition or disease Intervention/treatment Phase
Body Fat Disorder Device: The ZELTIQ System Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Non-Invasive Fat Reduction With Cryolipolysis for Jawline Contouring
Actual Study Start Date : December 8, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Fat Reduction
The treatments are designed to see if the fat can be reduced along the jawline with Cryolipolysis.
Device: The ZELTIQ System
The CoolSculpting machine will be used to perform the treatments.



Primary Outcome Measures :
  1. Safety endpoint in relation to adverse events [ Time Frame: Through study completion, an average of 9-months. ]
    Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs

  2. Photo review [ Time Frame: 12 weeks post second treatment. ]
    Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers.


Secondary Outcome Measures :
  1. Effectiveness endpoint gauged by reduction in fat layer thickness [ Time Frame: 12 weeks post second treatment. ]
    Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.



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Ages Eligible for Study:   22 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352141


Locations
Canada, British Columbia
Pacific Derm
Vancouver, British Columbia, Canada, V6H 4E1
Sponsors and Collaborators
Zeltiq Aesthetics
Investigators
Study Director: Kerrie Jiang, NP Zeltiq Aesthetics

Responsible Party: Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT03352141     History of Changes
Other Study ID Numbers: ZA17-004
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases