Cryolipolysis for Jawline Contouring

• The ZELTIQ System (Device): The CoolSculpting machine will be used to perform the treatments.

Primary outcomes

• Number of Participants With Unanticipated Adverse Device Effects (UADE) [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 [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.

Secondary outcomes

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

Sex: All, ages: 22 Years to 65 Years, accepts 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.

Participant flow

Outcome results

• Number of Participants With Unanticipated Adverse Device Effects (UADE) (Primary), Number, Participants with UADE reported: CoolSculpting for Jawline Contouring 0
• Number of Before and After Side-by-side Photograph Pairs Correctly Identified by At Least 2 of 3 Blinded, Independent Reviewers (Primary), Number, Number Photo Pairs Correctly Identified: CoolSculpting for Jawline Contouring 8
• Change in Fat Layer in the Treated Jawline Area (Secondary), Mean, cm: Submental Ultrasound Measurement -0.14 +/- 0.12; Submandibular Ultrasound Measurement (LEFT) -0.10 +/- 0.11; Submandibular Ultrasound Measurement (RIGHT) -0.10 +/- 0.11; Jowl Ultrasound Measurement (LEFT) -0.08 +/- 0.07; Jowl Ultrasound Measurement (RIGHT) -0.03 +/- 0.05
• Overall Satisfaction With the Treatment (Secondary), Count of participants, Participants: CoolSculpting for Jawline Contouring 9

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 by term

• Study Protocol and Statistical Analysis Plan (PDF, 2018-07-31)

• Lori Brandt, BSN, Study director, Zeltiq Aesthetics