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Cryolipolysis for Jawline Contouring (JAW)

Primary Purpose

Body Fat Disorder

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
The ZELTIQ System
Sponsored by
Zeltiq Aesthetics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Body Fat Disorder

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pacific Derm

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fat Reduction

Arm Description

The treatments are designed to see if the fat can be reduced along the jawline with Cryolipolysis.

Outcomes

Primary Outcome Measures

Safety endpoint in relation to adverse events
Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs
Photo review
Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers.

Secondary Outcome Measures

Effectiveness endpoint gauged by reduction in fat layer thickness
Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.

Full Information

First Posted
November 8, 2017
Last Updated
August 14, 2020
Sponsor
Zeltiq Aesthetics
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1. Study Identification

Unique Protocol Identification Number
NCT03352141
Brief Title
Cryolipolysis for Jawline Contouring
Acronym
JAW
Official Title
Non-Invasive Fat Reduction With Cryolipolysis for Jawline Contouring
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 8, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeltiq Aesthetics

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Fat Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fat Reduction
Arm Type
Experimental
Arm Description
The treatments are designed to see if the fat can be reduced along the jawline with Cryolipolysis.
Intervention Type
Device
Intervention Name(s)
The ZELTIQ System
Intervention Description
The CoolSculpting machine will be used to perform the treatments.
Primary Outcome Measure Information:
Title
Safety endpoint in relation to adverse events
Description
Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs
Time Frame
Through study completion, an average of 9-months.
Title
Photo review
Description
Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers.
Time Frame
12 weeks post second treatment.
Secondary Outcome Measure Information:
Title
Effectiveness endpoint gauged by reduction in fat layer thickness
Description
Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
Time Frame
12 weeks post second treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerrie Jiang, NP
Organizational Affiliation
Zeltiq Aesthetics
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Derm
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 4E1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Cryolipolysis for Jawline Contouring

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