Fat Reduction in the Submandibular/Submental Area

Not Applicable

Completed

• Conditions: Body Fat Disorder
• Interventions: Device: The ZELTIQ CoolSculpting System

• Registration Number: NCT02700165
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

The purpose of this study is to further evaluate the safety and efficacy of non-invasive reduction of subcutaneous fat in the submental and submandibular area using Cryolipolysis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-28
• Study Start: 2016-02
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-07
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2020-08-10
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-13
• Results First Posted: 2021-05-17
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CoolSculpting with CoolMini	The ZELTIQ CoolSculpting System	The treatments are designed to see if fat in the submandibular/submental area (chin), can be reduced using cryolipolysis.

Primary Outcome Measures

Name	Time	Method
Proportion of Accurately Identified Pre-Treatment Photos by a Panel of Blinded Independent Reviewers	Baseline (pre-treatment) and 12 weeks post treatment	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 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 images will be presented will be randomized; for each subject placement of the baseline, 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 70% correct identification of pre-treatment images by at least 70% correct identification of pre-treatment images by two out of three reviewers.
The Number of Unanticipated Adverse Device Effects (UADE) Reported	Enrollment through the 12 week final follow-up visit	The primary safety endpoint is the count of unanticipated adverse device effects (UADEs) reported in the study period. It is expected there will be zero UADEs.

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction	12 weeks post-treatment	Subject satisfaction as assessed by questionnaires administered at 12 weeks. Subjects will be asked to determine overall satisfaction with the treatment using a 5-point scale and free-text response options on a questionnaire. The choice options will be 1 = very dissatisfied, 2- dissatisfied, 3 - not sure, 4- satisfied and 5- very satisfied. Positive responses to questionnaire statements (score 4 or 5) will be used to assess satisfaction with the CoolSculpting procedure.
Change in Fat Layer Thickness of the Submental Area as Measured by Caliper	Baseline and 12 week post-treatment	Caliper measurements will be collected prior to treatment (pre-treatment) and at the 12-week follow-up visit. The caliper measurement process involves pinching the tissue within the treatment area in order to obtain the measurement, thereby folding the tissue and doubling the fat layer thickness. Measurements were taken with subjects standing in a neutral position.; Measured values (mm) will be halved to reflect single fat layer change and will not take into account the fold of tissue during the measurement process. The fat layer measured pre-treatment will be compared to the 12-week post-treatment measurement.

Trial Locations

Locations (1)

Main Line Center for Laser Surgery; 🇺🇸 Ardmore, Pennsylvania, United States