The purpose of this study is to evaluate the safety and efficacy of sequential use of CoolSculpting (Cryolipolysis) and radiofrequency treatment of the submental and submandibular area.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
8
Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.
Innovation Research Center
Pleasanton, California, United States
Number of Participants With Unanticipated Adverse Device Effects (UADEs)
UADEs were defined as any serious adverse effect on health and safety or any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of participants.
Time frame: From date of first treatment to 12 weeks after final treatment (up to 24 weeks)
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)
Photos obtained during the study were reviewed by an independent physician reviewer who entered assessments according to the Global Aesthetic Improvement Scale (GAIS). The GAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who were assessed as improved ("Very Much Improved," "Much Improved", and "Improved").
Time frame: Baseline, 12 weeks post radiofrequency treatment
Percent Change From Baseline in Fat Layer Thickness
Fat layer thickness was measured using a caliper at the center of the treatment area.
Time frame: Baseline, 12 weeks post radiofrequency treatment
Number of Participants With Improvement Based on Subject-graded Global Aesthetic Improvement Scale (SGAIS)
Participants rated improvement in their treatment areas based on the SGAIS. The SGAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who reported as improved ("Very Much Improved," "Much Improved", and "Improved").
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Time frame: Baseline, 12 weeks post radiofrequency treatment
Number of Participants With Positive Response in Subject Self-Rating Scale (SSRS) Score
Participants assessed their own satisfaction with their face and chin using the SSRS. The SSRS is a participants self-rating scale, scored on a 7-point scale with 0=extremely dissatisfied, 1=dissatisfied, 2=slightly dissatisfied, 3=neither satisfied nor dissatisfied, 4=slightly satisfied, 5=satisfied, and 6=extremely satisfied, with 6 representing higher participant satisfaction. Reported here is the number of participants with a score of 4 or higher, indicating satisfaction.
Time frame: Baseline, 12 weeks post radiofrequency treatment
Number of Participants With Positive Response on Subject Satisfaction Questionnaire
Participants reported their satisfaction with aspects of treatment on a written questionnaire which included a 5-point Likert scale ranging from -2 to 2, with -2 representing more negative response and 2 representing more positive response. Reported here are the numbers of participants with responses of 1 or 2, indicating a positive response, to the following categories: Comfort of Treatment Procedure, How Visible is Fat Reduction, Overall Effect from the Procedure, Overall Satisfaction with Treatment from the Procedure to the Result, Made Me Look More Youthful, Made My Chin Look More Toned, Feel Less Self-Conscious About Chin Fat, Overall Appearance Has Improved.
Time frame: Baseline, 12 Weeks Post Radiofrequency Treatment