CoolSculpting and RF for the Submental (CRT)

A Feasibility Study to Explore the Safety and Efficacy of Cryolipolysis Followed by Radiofrequency Treatment for Submental and Submandibular Contouring

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 Overview

• Status: Completed
• Conditions: Body Fat Disorder
• Intervention / Treatment: Device: The ZELTIQ System

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pleasanton, California, United States, 94588
      • Innovation Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• Male or female subjects ≥22 years of age and ≤65 years of age.
• Treatment area skin fold thickness > 1cm (measured by caliper).
• Dissatisfaction with the treatment area expressed by the subject as a rating of 0, 1 or 2 using the Subject Self Rating Scale (SSRS) as determined at Screening visit.
• 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

• Body Mass Index ≥ 46.2 as determined at screening.
• 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, chemical peels, radiofrequency or laser procedures that may affect contour in the treatment area within the past 6 months.
• Botulinum toxin, deoxycholic acid, 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, automatic implantable cardioverter/defibrillator (AICD), drug delivery system, or any other implantable electrical device.
• 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 including remaining clean shaven for all study visits.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryolipolysis Followed by Radiofrequency Treatment	Device: The ZELTIQ System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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").	Baseline, 12 weeks post radiofrequency treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Fat Layer Thickness	Fat layer thickness was measured using a caliper at the center of the treatment area.	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").	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.	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.	Baseline, 12 Weeks Post Radiofrequency Treatment

Collaborators and Investigators

• Sponsor: Zeltiq Aesthetics
• Investigators: Study Director: Kerrie Jiang, NP, Zeltiq Aesthetics

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2018
• Primary Completion (Actual): June 18, 2019
• Study Completion (Actual): June 18, 2019

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: ZA18-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No