Back to resultsFat Reduction in the Submandibular/Submental Area
Primary Purpose
Body Fat Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The ZELTIQ CoolSculpting System
Sponsored by
About this trial
This is an interventional treatment trial for Body Fat Disorder
Eligibility Criteria
Inclusion Criteria
- Male or female subjects > 22 years of age and < 65 years of age.
- Submental and submandibular skin fold thickness > 1cm (measured by caliper).
- 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
- Skin laxity in the neck or chin area for which reduction in submental and submandibular 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 submental fat
- Evidence of any cause of enlargement in the submental 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 neck or chin area (below the mandible) within the past 6 months.
- Botulinum toxin or other aesthetic drug injections within the neck or chin area (below the mandible) within 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 dental infection.
- 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, defibrillator, or drug delivery system.
- 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.
- 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.
Sites / Locations
- Main Line Center for Laser Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CoolSculpting with CoolMini
Arm Description
The treatments are designed to see if fat in the submandibular/submental area (chin), can be reduced using cryolipolysis.
Outcomes
Primary Outcome Measures
Proportion of Accurately Identified Pre-Treatment Photos by a Panel of 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 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
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
Change in Fat Layer Thickness of the Submental Area as Measured by Caliper
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.
Subject Satisfaction
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02700165
Brief Title
Fat Reduction in the Submandibular/Submental Area
Official Title
Non-Invasive Fat Reduction in the Chin Using Cryolipolysis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeltiq Aesthetics
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Fat Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CoolSculpting with CoolMini
Arm Type
Experimental
Arm Description
The treatments are designed to see if fat in the submandibular/submental area (chin), can be reduced using cryolipolysis.
Intervention Type
Device
Intervention Name(s)
The ZELTIQ CoolSculpting System
Intervention Description
The CoolSculpting device will be used to perform the treatments.
Primary Outcome Measure Information:
Title
Proportion of Accurately Identified Pre-Treatment Photos by a Panel of Blinded Independent Reviewers
Description
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.
Time Frame
Baseline (pre-treatment) and 12 weeks post treatment
Title
The Number of Unanticipated Adverse Device Effects (UADE) Reported
Description
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.
Time Frame
Enrollment through the 12 week final follow-up visit
Secondary Outcome Measure Information:
Title
Change in Fat Layer Thickness of the Submental Area as Measured by Caliper
Description
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.
Time Frame
Baseline and 12 week post-treatment
Title
Subject Satisfaction
Description
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.
Time Frame
12 weeks post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Male or female subjects > 22 years of age and < 65 years of age.
Submental and submandibular skin fold thickness > 1cm (measured by caliper).
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
Skin laxity in the neck or chin area for which reduction in submental and submandibular 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 submental fat
Evidence of any cause of enlargement in the submental 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 neck or chin area (below the mandible) within the past 6 months.
Botulinum toxin or other aesthetic drug injections within the neck or chin area (below the mandible) within 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 dental infection.
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, defibrillator, or drug delivery system.
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Bernstein, MD
Organizational Affiliation
Main Line Center for Laser Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Main Line Center for Laser Surgery
City
Ardmore
State/Province
Pennsylvania
ZIP/Postal Code
19003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28426847
Citation
Bernstein EF, Bloom JD. Safety and Efficacy of Bilateral Submental Cryolipolysis With Quantified 3-Dimensional Imaging of Fat Reduction and Skin Tightening. JAMA Facial Plast Surg. 2017 Sep 1;19(5):350-357. doi: 10.1001/jamafacial.2017.0102.
Results Reference
background
Learn more about this trial
Fat Reduction in the Submandibular/Submental Area
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