- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03352141
Cryolipolysis for Jawline Contouring (JAW)
August 14, 2020 updated by: Zeltiq Aesthetics
Non-Invasive Fat Reduction With Cryolipolysis for Jawline Contouring
The purpose of this study is to evaluate the safety and efficacy of non-invasive reduction of subcutaneous fat along the jawline with Cryolipolysis.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada, V6H 4E1
- Pacific Derm
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fat Reduction
The treatments are designed to see if the fat can be reduced along the jawline with Cryolipolysis.
|
The CoolSculpting machine will be used to perform the treatments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety endpoint in relation to adverse events
Time Frame: Through study completion, an average of 9-months.
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Measurement of device- or procedure-related adverse events.
It is expected there will be zero UADEs
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Through study completion, an average of 9-months.
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Photo review
Time Frame: 12 weeks post second treatment.
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Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers.
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12 weeks post second treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness endpoint gauged by reduction in fat layer thickness
Time Frame: 12 weeks post second treatment.
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Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
|
12 weeks post second treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kerrie Jiang, NP, Zeltiq Aesthetics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 8, 2017
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
November 8, 2017
First Submitted That Met QC Criteria
November 21, 2017
First Posted (Actual)
November 24, 2017
Study Record Updates
Last Update Posted (Actual)
August 18, 2020
Last Update Submitted That Met QC Criteria
August 14, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZA17-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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