Body Fat DisorderJAWNCT03352141

Cryolipolysis for Jawline Contouring

A study testing The ZELTIQ System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 22 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Body Fat Disorder
What is being tested?: The ZELTIQ System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteCanada
Study dates: 18 Dec 2017to 11 Nov 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 21Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Pacific Derm
Vancouver, British Columbia, V6H 4E1

Other trials in Canada

About this study

Official title: 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.

Conditions: Body Fat Disorder
Being tested: The ZELTIQ System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The ZELTIQ SystemDevice
The CoolSculpting machine will be used to perform the treatments.

Study groups in NCT03352141
Study group	Role	What they receive
Fat Reduction	Experimental	The treatments are designed to see if the fat can be reduced along the jawline with Cryolipolysis. Receives: Device: The ZELTIQ System

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Unanticipated Adverse Device Effects (UADE)
This outcome measurement considered all unanticipated device- or procedure-related adverse effects.
Measured: Enrollment through study completion, an average of 6 months.
Number of Before and After Side-by-side Photograph Pairs Correctly Identified by At Least 2 of 3 Blinded, Independent Reviewers
Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment (baseline) and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which photographs will be presented will be randomized; for each subject placement of the baseline and pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Success is defined as 75% correct identification of pre-treatment photos by 2 out of 3 reviewers.
Measured: Baseline through 12 weeks post second treatment.

Secondary outcomes (2)

Change in Fat Layer in the Treated Jawline Area
When compared to baseline ultrasound imaging, the change in fat layer thickness at the final post-treatment visit will be measured. Ultrasound measurements were obtained in 5 areas intended for treatment at the baseline visit. A template was created for identification of the locations for subsequent measurements using external landmarks (e.g. skin imperfections) as reference points. The Treatment Effect = Follow-Up Average Thickness - Baseline Average Thickness. A negative change reflects a decrease in the average thickness from the baseline visit to the follow-up visit, and a positive result reflects an increase.
Measured: Baseline and 12 weeks post-final treatment.
Overall Satisfaction With the Treatment
Subject satisfaction with the CoolSculpting procedure will be assessed by a questionnaire administered at the 12-week post-final treatment follow-up visit. The questionnaire will consist of 5-point Likert questions with 1 = very dissatisfied; 2 = dissatisfied; 3 = not sure; 4 = satisfied and 5 = very satisfied. Positive responses (very satisfied and satisfied) will be reported.
Measured: 12-week post-final treatment follow-up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 201711 Nov 2019

First posted24 Nov 2017
Study start18 Dec 2017
Primary completion11 Nov 2019
Study completion11 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Body Fat DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03352141
Sponsor's protocol ID: ZA17-004
Acronym: JAW
Status last verified: Jul 2025
First submitted: 8 Nov 2017
Last updated: 23 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Body Fat Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Invasive Fat Reduction With Cryolipolysis for Jawline Contouring
ClinicalTrials.gov ID: NCT03352141
Acronym / sponsor ID: JAW / ZA17-004
Conditions: Body Fat Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Zeltiq AestheticsIndustry (pharma, biotech, devices)
Study start: 18 Dec 2017 (actual)
Primary completion: 11 Nov 2019 (actual)
Study completion: 11 Nov 2019 (actual)
First posted: 24 Nov 2017 (actual)
Results: Posted 23 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fat Reduction	Experimental	Device: The ZELTIQ SystemThe treatments are designed to see if the fat can be reduced along the jawline with Cryolipolysis.

Who may qualify

Ages: 22 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (21 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The ZELTIQ SystemThe CoolSculpting machine will be used to perform the treatments.	Device	Fat Reduction

Primary outcome

Number of Participants With Unanticipated Adverse Device Effects (UADE)
Time frame: Enrollment through study completion, an average of 6 months.
This outcome measurement considered all unanticipated device- or procedure-related adverse effects.
Number of Before and After Side-by-side Photograph Pairs Correctly Identified by At Least 2 of 3 Blinded, Independent Reviewers
Time frame: Baseline through 12 weeks post second treatment.
Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment (baseline) and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which photographs will be presented will be randomized; for each subject placement of the baseline and pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Success is defined as 75% correct identification of pre-treatment photos by 2 out of 3 reviewers.

2 secondary outcomes

Change in Fat Layer in the Treated Jawline Area
Time frame: Baseline and 12 weeks post-final treatment.
Overall Satisfaction With the Treatment
Time frame: 12-week post-final treatment follow-up visit

Results and safety

Results posted to the registry on 23 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CoolSculpting for Jawline Contouring	15	15

Primary outcome: Number of Participants With Unanticipated Adverse Device Effects (UADE)

Time frame: Enrollment through study completion, an average of 6 months.. Number. Unit: Participants with UADE reported

Measure	CoolSculpting for Jawline Contouring n = 15
Value	0

Population analysed: All 15 enrolled subjects were evaluated by the study investigator for unanticipated adverse device effects throughout the duration of the study.

Primary outcome: Number of Before and After Side-by-side Photograph Pairs Correctly Identified by At Least 2 of 3 Blinded, Independent Reviewers

Time frame: Baseline through 12 weeks post second treatment.. Number. Unit: Number Photo Pairs Correctly Identified

Measure	CoolSculpting for Jawline Contouring n = 14
Value	8

Population analysed: Fourteen (14) of the enrolled subjects were included in the analysis of efficacy. One (1) subject was excluded due to body weight outside the requirements of the protocol.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from the time of enrollment through the final 12-week post-final treatment follow-up visit, an average of 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CoolSculpting for Jawline Contouring	0 of 15 (0%)	2 of 15 (13.3%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Body Fat Disorder

RecruitingPhase 4
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Obesity (Disorder)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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Impact of Significant Surgical Reduction of Adipose Tissue on Plasma Levels and Genetic Expression of Adipokines Associated With Ischemic Heart Disease in Type I Obesity.
Obesity & Overweight, Obesity Type I and II
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Active, not recruitingPhase 1/2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lori Brandt, BSN study director

Zeltiq Aesthetics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The ZELTIQ System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Unanticipated Adverse Device Effects (UADE) (time frame: Enrollment through study completion, an average of 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03352141.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.