Cryolipolysis for Jawline Contouring

NCT03352141 | Completed Results FDA Device

• 1 other identifier: ZA17-004
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Fat Disorder

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Unanticipated Adverse Device Effects (UADE)

  This outcome measurement considered all unanticipated device- or procedure-related adverse effects.

  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.

  Baseline through 12 weeks post second treatment.

Secondary Outcomes (2)

• Change in Fat Layer in the Treated Jawline Area

  Baseline and 12 weeks post-final treatment.

• Overall Satisfaction With the Treatment

  12-week post-final treatment follow-up visit

Study Arms (1)

Fat Reduction

EXPERIMENTAL

The treatments are designed to see if the fat can be reduced along the jawline with Cryolipolysis.

Device: The ZELTIQ System

Interventions

The ZELTIQ System DEVICE

The CoolSculpting machine will be used to perform the treatments.

Fat Reduction

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).
• Sufficient treatment area requiring at least 2 cooling cycles.
• 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:

• 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, radiofrequency or laser procedures, or chemical peels in the treatment area (below the mandible) within the past 6 months.
• Botulinum toxin 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.

Sponsors & Collaborators

• Zeltiq Aesthetics: lead

Study Sites (1)

Pacific Derm

Vancouver, British Columbia, V6H 4E1, Canada

Location

Results Point of Contact

• Title: Lori Brandt, Director Cinical Trial Management
• Organization: Zeltiq Aesthetics

lori.brandt@abbvie.com

(925) 621-7460

Study Officials

• Lori Brandt, BSN

  Zeltiq Aesthetics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 24, 2017
• Study Start: December 18, 2017
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: July 23, 2025
• Results First Posted: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)