Body Fat Disorder
Conditions
Brief summary
Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area using Cryolipolysis. Healthy adult men and women with submental skin fold thickness \> 1cm who desire reduction of submental fat.
Detailed description
Non-invasive treatment for subcutaneous fat reduction in the submental area.
Interventions
DEVICECoolSculpting System
Sponsors
Zeltiq Aesthetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects \> 22 years of age and \< 65 years of age. * Submental 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 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, 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of CoolScupting in the Submental Area | Time of enrollment through12 week post-final treatment follow-up | Safety of the Zeltiq CoolSculpting device will be assessed by measuring the incidence of device- and/or procedure-related adverse events. Adverse event reports are collected from the time of enrollment through the 12 week follow-up visit. |
| Percentage of Correct Identification of Pre-treatment Photographs | 12 week post-final-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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction With CoolScupting in the Submental Area | 12 weeks post-final treatment | Subject satisfaction as assessed by questionnaires administered at 12 weeks post-final treatment. The questionnaire will ask the subject about their treatment experience and the efficacy of the treatment. |
| Change in the Fat Layer of the Treated Area as Measured by Ultrasound | 12 weeks post-final treatment | Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Results indicate the fat layer reduction in cm. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CoolSculpting Treatment Subjects treated with CoolSculpting for fat reduction in the submittal area | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | CoolSculpting Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Age, Continuous | 49.3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 15 / 60 |
| serious Total, serious adverse events | 2 / 60 |
Outcome results
Primary
Percentage of Correct Identification of Pre-treatment Photographs
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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure.
Time frame: 12 week post-final-treatment
Population: Subjects included in the analysis group (58) received full treatment; treatment was interrupted for 2 subjects not included in this population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoolSculpting Treatment | Percentage of Correct Identification of Pre-treatment Photographs | 91.4 percentage of correcty identified photos |
p-value: <0.000195% CI: [86.2, 95.1]t-test, 1 sided
Primary
Safety of CoolScupting in the Submental Area
Safety of the Zeltiq CoolSculpting device will be assessed by measuring the incidence of device- and/or procedure-related adverse events. Adverse event reports are collected from the time of enrollment through the 12 week follow-up visit.
Time frame: Time of enrollment through12 week post-final treatment follow-up
Population: As-treated population of 60 subjects who received CoolSculpting treatment for subcutaneous fat reduction in the submental area.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoolSculpting Treatment | Safety of CoolScupting in the Submental Area | 4 incidence of device- and/or procedure AE |
Secondary
Change in the Fat Layer of the Treated Area as Measured by Ultrasound
Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Results indicate the fat layer reduction in cm.
Time frame: 12 weeks post-final treatment
Population: Evaluable ultrasound images were available for 57 of the 59 subjects completing the 12 week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CoolSculpting Treatment | Change in the Fat Layer of the Treated Area as Measured by Ultrasound | -0.20 cm fat layer reduction post-procedure | Standard Deviation 0.19 |
Secondary
Subject Satisfaction With CoolScupting in the Submental Area
Subject satisfaction as assessed by questionnaires administered at 12 weeks post-final treatment. The questionnaire will ask the subject about their treatment experience and the efficacy of the treatment.
Time frame: 12 weeks post-final treatment
Population: As-treated population of subjects who received CoolSculpting for subcutaneous fat reduction of the submental area who completed a Subject Satisfaction Questionnaire at the 12-week final follow-up visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CoolSculpting Treatment | Subject Satisfaction With CoolScupting in the Submental Area | Visible/Very Visible Fat Reduction | 46 Participants |
| CoolSculpting Treatment | Subject Satisfaction With CoolScupting in the Submental Area | Satisfied/VerySatisfied with CoolSculpting | 50 Participants |
| CoolSculpting Treatment | Subject Satisfaction With CoolScupting in the Submental Area | Procedure was Very Comfortable/Comfortable | 45 Participants |
| CoolSculpting Treatment | Subject Satisfaction With CoolScupting in the Submental Area | Strongly Agree/Agree Procedure made more youthful | 30 Participants |
| CoolSculpting Treatment | Subject Satisfaction With CoolScupting in the Submental Area | Strongly Agree/Agree chin looked more toned | 45 Participants |
| CoolSculpting Treatment | Subject Satisfaction With CoolScupting in the Submental Area | Strongly Agree/Agree appearance has improved | 46 Participants |
| CoolSculpting Treatment | Subject Satisfaction With CoolScupting in the Submental Area | Effect from procedure More Than Expected/Expected | 40 Participants |
| CoolSculpting Treatment | Subject Satisfaction With CoolScupting in the Submental Area | Would recommend procedure to a friend | 48 Participants |
| CoolSculpting Treatment | Subject Satisfaction With CoolScupting in the Submental Area | Feel less self-conscious about chin fat | 43 Participants |