Cryolipolysis for Jawline Contouring (NCT03352141) | Clinical Trial Compass
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 range22 Years – 65 Years
SexALL
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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…
What they're measuring
1
Number of Participants With Unanticipated Adverse Device Effects (UADE)
Timeframe: Enrollment through study completion, an average of 6 months.
2
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.