Cryolipolysis for Jawline Contouring

Not Applicable

Completed

• Conditions: Body Fat Disorder

• Registration Number: NCT03352141
• Lead Sponsor: Zeltiq Aesthetics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-24
• Study Start: 2017-12-18
• Primary Completion: 2019-11-11
• Study Completion: 2019-11-11
• Results First Submitted: 2021-12-09
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Results First Posted: 2025-07-23
• Last Update Posted: 2025-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pacific Derm; 🇨🇦 Vancouver, British Columbia, Canada