CompletedNot Applicable

Cryolipolysis for Jawline Contouring

Canada15 participantsStarted 2017-12-18

Plain-language 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.

Who can participate

Age range

22 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 implan…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Unanticipated Adverse Device Effects (UADE)

Timeframe: 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

Timeframe: Baseline through 12 weeks post second treatment.

Trial details

NCT IDNCT03352141

SponsorZeltiq Aesthetics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-11

Results submitted2021-12-09

View on ClinicalTrials.gov More Body Fat Disorder trials