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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The CoolSculpting machine will be used to perform the treatments.
Pacific Derm
Vancouver, British Columbia, Canada
Number of Participants With Unanticipated Adverse Device Effects (UADE)
This outcome measurement considered all unanticipated device- or procedure-related adverse effects.
Time frame: 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.
Time frame: Baseline through 12 weeks post second treatment.
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.
Time frame: Baseline and 12 weeks post-final treatment.
Overall Satisfaction With the Treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 12-week post-final treatment follow-up visit