CoolSculpting and RF for the Submental

NCT03873779 | Completed Results FDA Device

• 1 other identifier: ZA18-002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Body Fat Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Percent Change From Baseline in Fat Layer Thickness

  Baseline, 12 weeks post radiofrequency treatment

• Number of Participants With Improvement Based on Subject-graded Global Aesthetic Improvement Scale (SGAIS)

  Baseline, 12 weeks post radiofrequency treatment

• Number of Participants With Positive Response in Subject Self-Rating Scale (SSRS) Score

  Baseline, 12 weeks post radiofrequency treatment

• Number of Participants With Positive Response on Subject Satisfaction Questionnaire

  Baseline, 12 Weeks Post Radiofrequency Treatment

Study Arms (1)

Cryolipolysis Followed by Radiofrequency Treatment

EXPERIMENTAL

Device: The ZELTIQ System

Interventions

The ZELTIQ System DEVICE

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.

Cryolipolysis Followed by Radiofrequency Treatment

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeltiq Aesthetics: lead

Study Sites (1)

Innovation Research Center

Pleasanton, California, 94588, United States

Location

Results Point of Contact

• Title: Sally Hallas, RN, Director Clinical Development - Body Contouring
• Organization: Zeltiq

sally.hallas@abbvie.com

209-294-5571

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: March 13, 2019
• Study Start: December 18, 2018
• Primary Completion: June 18, 2019
• Study Completion: June 18, 2019
• Last Updated: March 10, 2025
• Results First Posted: March 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)