Cryolipolysis for Jawline Contouring (JAW)

• ClinicalTrials.gov Identifier: NCT03352141
• Recruitment Status: Active, not recruiting
• First Posted: November 24, 2017
• Last Update Posted: August 18, 2020
• Sponsor: Zeltiq Aesthetics
• Information provided by (Responsible Party): Zeltiq Aesthetics

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 45 participants
• Allocation: N/A
• 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 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 65 Years (Adult, Older 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.

Contacts and Locations

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

More Information

• Responsible Party: Zeltiq Aesthetics
• ClinicalTrials.gov Identifier: NCT03352141
• Other Study ID Numbers: ZA17-004
• First Posted: November 24, 2017
• Last Update Posted: August 18, 2020
• Last Verified: August 2020

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