Body Fat Disorder
Conditions
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.
Interventions
The CoolSculpting device will be used to perform the treatments.
Sponsors
Zeltiq Aesthetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Subjects seeking reduction of fat in the submental and submandibular area were recruited from the general population.
Participants by arm
| Arm | Count |
|---|---|
| CoolSculpting With CoolMini Applicator ZELTIQ CoolSculpting System Treatment Group | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | CoolSculpting With CoolMini Applicator |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 50.5 years |
| Body Mass Index | 33.1 kg/m^2 |
| Race/Ethnicity, Customized African American | 2 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 12 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Region of Enrollment United States | 14 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 3 / 14 |
| serious Total, serious adverse events | 1 / 14 |
Outcome results
Primary
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.
Time frame: Baseline (pre-treatment) and 12 weeks post treatment
Population: All subjects were included in the analysis population.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CoolSculpting With CoolMini Applicator | Proportion of Accurately Identified Pre-Treatment Photos by a Panel of Blinded Independent Reviewers | 11 photos |
95% CI: [49.2, 95.3]
Primary
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.
Time frame: Enrollment through the 12 week final follow-up visit
Population: The per-protocol population of 14 subjects was analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoolSculpting With CoolMini Applicator | The Number of Unanticipated Adverse Device Effects (UADE) Reported | 0 UADEs |
Secondary
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.
Time frame: Baseline and 12 week post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CoolSculpting With CoolMini Applicator | Change in Fat Layer Thickness of the Submental Area as Measured by Caliper | -2.3 millimeters fat layer change | Standard Deviation 0.8 |
Secondary
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.
Time frame: 12 weeks post-treatment
Population: The per-protocol population of 14 subjects was included the analysis group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CoolSculpting With CoolMini Applicator | Subject Satisfaction | Procedure comfortable/very comfortable | 7 Participants |
| CoolSculpting With CoolMini Applicator | Subject Satisfaction | Visible fat/very visible fat reduction | 10 Participants |
| CoolSculpting With CoolMini Applicator | Subject Satisfaction | Agree/strongly agree appearance more youthful | 9 Participants |
| CoolSculpting With CoolMini Applicator | Subject Satisfaction | Agree/strongly agree chin looked more toned | 12 Participants |
| CoolSculpting With CoolMini Applicator | Subject Satisfaction | Agree/strongly agree less self-conscious of chin | 11 Participants |
| CoolSculpting With CoolMini Applicator | Subject Satisfaction | Agree/strongly agree appearance improved | 11 Participants |
| CoolSculpting With CoolMini Applicator | Subject Satisfaction | Agree/strongly agree result was as expected | 11 Participants |
| CoolSculpting With CoolMini Applicator | Subject Satisfaction | Satisfied/very satisfied with CoolSculpting | 13 Participants |
| CoolSculpting With CoolMini Applicator | Subject Satisfaction | Would recommend procedure to a friend | 13 Participants |