Non-invasive Fat Reduction
Conditions
Keywords
Fat Reduction Non-invasive
Brief summary
This study aims to generate data that conveys participant's experiences such as their satisfaction with treatment delivered by the redesigned CoolSculpting® Elite system for non-invasive fat reduction in the midsection area (abdomen and flanks) in addition to optional body areas of upper arms, inner thighs, outer thighs and/or submental area. By doing this, the study will provide insights for doctors to better inform participants about the expected outcomes when one or more body areas are considered for treatment.
Interventions
DEVICECoolSculpting® Elite System with CoolSculpting® Elite applicators
A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.
Sponsors
Allergan
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
No
Inclusion criteria
Inclusion Criteria: * Participant must be in good health as determined by medical history, physical examination, vital signs, and investigator's judgment, including no known active pandemic infection. * Participant has clearly visible and palpable fat in the abdomen and flanks, and participant may also be assessed for visible and palpable fat in one or more of the following body areas: left and right lower aspects of the upper arms, left and right inner thigh, left and right outer thigh, or submental area, which in the investigator's opinion is appropriate for and may benefit from treatment. * Participant has a BMI of ≥ 18.5 and \< 30. BMI is defined as weight in kilograms divided by height in meters squared (kg/m2). * Participant agrees to maintain weight (ie, within 5% of body weight) by not making any changes in diet or exercise routine during the course of the study. * Participant agrees to have photographs taken of the treatment area(s) during the scheduled time periods.
Exclusion criteria
* Participant has a history of an invasive fat reduction procedure (eg, liposuction, surgery, lipolytic agents, etc) within or adjacent to the area being considered for treatment. * Participant has implants (eg, breast implants) in or immediately adjacent to the area of intended treatment. * Participant has a history of prior surgery or scar tissue related to the area being considered for treatment. * Participant has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria. * Participant has a known sensitivity to cold or has any condition with a known response to cold exposure that limits blood flow to the skin, such as cold urticaria, Raynaud's disease, or chilblains (pernio). * Participant with a clinically significant bleeding disorder, or concomitant use of blood thinners, or is taking any medication that, in the investigator's opinion, may significantly increase the participant's risk of bruising or bleeding. * Participant has a history of carpal tunnel syndrome, compartment syndrome, or deep vein thrombosis in the upper or lower extremities (only applicable for participants receiving treatment to the upper arms or thighs). * Participant is currently taking or has taken diet pills or weight control supplements within the past 6 months. * Participant has any skin conditions, such as moderate to excessive skin laxity, open wound, or scars, and active infection, eczema, dermatitis or rashes in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks are not an exclusion). * Participant has an active implanted device such as a pacemaker, defibrillator, drug delivery system, or any other metal-containing implant, within or adjacent to the area being considered for treatment. * Participant (WOCBP- woman of childbearing potential) is pregnant or intending to become pregnant in the next 3 to 6 months and does not agree to use reliable contraception during the study. * Participant is lactating or has been lactating in the past 6 months. * Participant is unable or unwilling to comply with the study requirements. * Participant is currently enrolled in a clinical study of any unapproved investigational device, investigational product, or any other type of medical research judged not to be scientifically or medically compatible with this study. * Participant has any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the participant's response or the integrity of the data or would pose an unacceptable risk to the participant. * Participant has had a non-invasive fat reduction and/or body contouring procedure in the area(s) of intended treatment within the past 12 months. * Participant needs to administer, or has a known history of subcutaneous injections, into the area(s) of intended treatment (eg, cortisone, heparin, insulin) within the past 6 months. * Participant with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol. * Participant has impaired peripheral circulation in the area to be treated. * Participant has neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy. * Participant has impaired skin sensation in or immediately adjacent to the treatment area(s). * Participant has a history of hernia in or immediately adjacent to the treatment area(s). * Participant diagnosed with a systemic fibrosing disease or fibrosis in the area intended or adjacent to the area to be treated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Satisfied or Very Satisfied on Item #1 for the CSQ (Cryolipolysis Satisfaction Questionnaire) - Midsection | 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions) | The CSQ-Midsection is a 2-item Patient-reported Outcome (PRO) instrument that measures participant's satisfaction with CoolSculpting® treatment of the midsection (abdomen and flanks). Participants were asked to rate their satisfaction with the results of the fat-reduction procedure on a 5-item scale ranging from Very satisfied to Very dissatisfied. |
| Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | First treatment to Follow-up/Exit Visit (Week 12 + 14 days for those participants who received only 1 treatment session and Week 20 + 14 days for those participants who received 2 treatment sessions) | An AE will be considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date (and time, if known) of the first dose of study intervention. An AE will be considered a TESAE if it is a TEAE that additionally meets any SAE criterion. TEADE is defined as any TEAE with a reasonable possibility (Possible, Probable, or Causal relationship) that the event may have been caused by the study device. SADE is an ADE that might have led to any SAE consequences if a suitable action had not been taken or intervention had not been made. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Received Treatment to Abdomen and Flank and One or More Additional Body Areas for Treatment With Satisfied or Very Satisfied on CSQ-Overall Item 1 | 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions) | The CSQ-Overall is a 1-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® Elite treatment when midsection and one or more additional body area were selected for treatment. Participants were asked to rate their satisfaction with the results of the fat-reduction procedure when considering the treated areas using a 5-item scale ranging from Very satisfied to Very dissatisfied. |
| Percentage of Participants With Satisfied or Very Satisfied on Individual Treated Body Areas (Upper Arms, Inner Thighs, Outer Thighs, Fat Under Chin) CSQ Item 1 | 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions) | The CSQ- Upper Arms, CSQ-Inner Thighs, CSQ-Outer Thighs, CSQ-Fat Under Chin are 1-item Patient-reported Outcome (PRO) instruments that measure participant's satisfaction with CoolSculpting® Elite treatment for the optional additional individual body area(s) treated. Participants were asked to rate their satisfaction with the results of the fat-reduction procedure for the optional additional individual body area(s) treated on a 5-item scale ranging from Very satisfied to Very dissatisfied. |
| Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers | 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who recieved 2 treatment sessions) | Success was defined as at least 70% correct identification of the pre-treatment images. |
Countries
France, Germany, Singapore, Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CoolSculpting® Elite System Participants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs. | 110 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Reason not Specified | 2 |
| Overall Study | Withdrawal of Consent | 1 |
Baseline characteristics
| Characteristic | CoolSculpting® Elite System |
|---|---|
| Age, Continuous | 43.0 years STANDARD_DEVIATION 12.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized Race Black or African American | 3 Participants |
| Race/Ethnicity, Customized Race Chinese | 11 Participants |
| Race/Ethnicity, Customized Race Middle Eastern | 1 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants |
| Race/Ethnicity, Customized Race Taiwanese | 1 Participants |
| Race/Ethnicity, Customized Race White or Caucasian | 61 Participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 100 |
| other Total, other adverse events | 5 / 110 | 5 / 100 |
| serious Total, serious adverse events | 0 / 110 | 0 / 100 |
Outcome results
Primary
Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs
An AE will be considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date (and time, if known) of the first dose of study intervention. An AE will be considered a TESAE if it is a TEAE that additionally meets any SAE criterion. TEADE is defined as any TEAE with a reasonable possibility (Possible, Probable, or Causal relationship) that the event may have been caused by the study device. SADE is an ADE that might have led to any SAE consequences if a suitable action had not been taken or intervention had not been made.
Time frame: First treatment to Follow-up/Exit Visit (Week 12 + 14 days for those participants who received only 1 treatment session and Week 20 + 14 days for those participants who received 2 treatment sessions)
Population: Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). AEs are reported separately for each of the two treatment sessions.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CoolSculpting® Elite System | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Treatment-Emergent Adverse Event (TEAE) | 5 Participants |
| CoolSculpting® Elite System | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Treatment-Emergent Serious Adverse Event (TESAE) | 0 Participants |
| CoolSculpting® Elite System | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Unanticipated Treatment-Emergent Adverse Event (UTEAE) | 0 Participants |
| CoolSculpting® Elite System | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Unanticipated Treatment-Emergent Serious Adverse Event (UTESAE) | 0 Participants |
| CoolSculpting® Elite System | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Treatment-Emergent Adverse Device Effect (TEADE) | 2 Participants |
| CoolSculpting® Elite System | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Treatment-Emergent Serious Adverse Device Effect (TESADE) | 0 Participants |
| CoolSculpting® Elite System | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Unanticipated Treatment-Emergent Adverse Device Effect (UTEADE) | 0 Participants |
| CoolSculpting® Elite System | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Unanticipated Treatment-Emergent Serious Adverse Device Effect (UTESADE) | 0 Participants |
| CoolSculpting® Elite: Treatment Session 2 | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Unanticipated Treatment-Emergent Serious Adverse Device Effect (UTESADE) | 0 Participants |
| CoolSculpting® Elite: Treatment Session 2 | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Treatment-Emergent Adverse Event (TEAE) | 5 Participants |
| CoolSculpting® Elite: Treatment Session 2 | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Treatment-Emergent Adverse Device Effect (TEADE) | 4 Participants |
| CoolSculpting® Elite: Treatment Session 2 | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Treatment-Emergent Serious Adverse Event (TESAE) | 0 Participants |
| CoolSculpting® Elite: Treatment Session 2 | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Unanticipated Treatment-Emergent Adverse Device Effect (UTEADE) | 0 Participants |
| CoolSculpting® Elite: Treatment Session 2 | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Unanticipated Treatment-Emergent Adverse Event (UTEAE) | 0 Participants |
| CoolSculpting® Elite: Treatment Session 2 | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Treatment-Emergent Serious Adverse Device Effect (TESADE) | 0 Participants |
| CoolSculpting® Elite: Treatment Session 2 | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | Any Unanticipated Treatment-Emergent Serious Adverse Event (UTESAE) | 0 Participants |
Primary
Percentage of Participants With Satisfied or Very Satisfied on Item #1 for the CSQ (Cryolipolysis Satisfaction Questionnaire) - Midsection
The CSQ-Midsection is a 2-item Patient-reported Outcome (PRO) instrument that measures participant's satisfaction with CoolSculpting® treatment of the midsection (abdomen and flanks). Participants were asked to rate their satisfaction with the results of the fat-reduction procedure on a 5-item scale ranging from Very satisfied to Very dissatisfied.
Time frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)
Population: Evaluable Population 1 consisted of all participants who completed the cryolipolysis treatment plan to the midsection and completed the Cryolipolysis Satisfaction Questionnaire (CSQ)-Midsection Item #1 at 12 weeks after the final treatment session and who do not have any significant protocol deviation or violation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoolSculpting® Elite System | Percentage of Participants With Satisfied or Very Satisfied on Item #1 for the CSQ (Cryolipolysis Satisfaction Questionnaire) - Midsection | 83.3 percentage of participants |
Secondary
Percentage of Participants Who Received Treatment to Abdomen and Flank and One or More Additional Body Areas for Treatment With Satisfied or Very Satisfied on CSQ-Overall Item 1
The CSQ-Overall is a 1-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® Elite treatment when midsection and one or more additional body area were selected for treatment. Participants were asked to rate their satisfaction with the results of the fat-reduction procedure when considering the treated areas using a 5-item scale ranging from Very satisfied to Very dissatisfied.
Time frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)
Population: Evaluable Population 3 (N=107) consisted of all participants who completed the cryolipolysis treatment plan for any body areas (Midsection, Upper Arms, Inner Thighs, Outer Thighs and Submental Area) and do not have any significant protocol deviation or violation. Overall number analyzed is the number of participants available for analysis for CSQ-Overall Item 1 (n=53).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoolSculpting® Elite System | Percentage of Participants Who Received Treatment to Abdomen and Flank and One or More Additional Body Areas for Treatment With Satisfied or Very Satisfied on CSQ-Overall Item 1 | 83.0 percentage of participants |
Secondary
Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers
Success was defined as at least 70% correct identification of the pre-treatment images.
Time frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who recieved 2 treatment sessions)
Population: Evaluable Population 3 (N=107) consisted of all participants who completed the cryolipolysis treatment plan for any body areas (Midsection, Upper Arms, Inner Thighs, Outer Thighs and Submental Area) and do not have any significant protocol deviation or violation. Overall number analyzed is the number of participants evaluable for any of the body areas. Number analyzed for each category are the number of participants evaluable for the respective individual body area.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CoolSculpting® Elite System | Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers | Upper Arms | 80.0 percentage of participants |
| CoolSculpting® Elite System | Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers | Midsection | 88.0 percentage of participants |
| CoolSculpting® Elite System | Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers | Inner Thighs | 60.0 percentage of participants |
| CoolSculpting® Elite System | Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers | Outer Thighs | 100 percentage of participants |
| CoolSculpting® Elite System | Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers | Submental Area | 66.7 percentage of participants |
Secondary
Percentage of Participants With Satisfied or Very Satisfied on Individual Treated Body Areas (Upper Arms, Inner Thighs, Outer Thighs, Fat Under Chin) CSQ Item 1
The CSQ- Upper Arms, CSQ-Inner Thighs, CSQ-Outer Thighs, CSQ-Fat Under Chin are 1-item Patient-reported Outcome (PRO) instruments that measure participant's satisfaction with CoolSculpting® Elite treatment for the optional additional individual body area(s) treated. Participants were asked to rate their satisfaction with the results of the fat-reduction procedure for the optional additional individual body area(s) treated on a 5-item scale ranging from Very satisfied to Very dissatisfied.
Time frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)
Population: Evaluable Population consisted of all participants who completed the cryolipolysis treatment plan to one or more additional body areas (Upper Arms, Inner Thighs, Outer Thighs, Submental Area), whether midsection treatment was completed or not, and do not have any significant protocol deviation or violation. Number analyzed for each category is the number of participants with available data for the respective individual body area.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CoolSculpting® Elite System | Percentage of Participants With Satisfied or Very Satisfied on Individual Treated Body Areas (Upper Arms, Inner Thighs, Outer Thighs, Fat Under Chin) CSQ Item 1 | CSQ - Inner Thighs | 58.3 percentage of participants |
| CoolSculpting® Elite System | Percentage of Participants With Satisfied or Very Satisfied on Individual Treated Body Areas (Upper Arms, Inner Thighs, Outer Thighs, Fat Under Chin) CSQ Item 1 | CSQ - Outer Thighs | 33.3 percentage of participants |
| CoolSculpting® Elite System | Percentage of Participants With Satisfied or Very Satisfied on Individual Treated Body Areas (Upper Arms, Inner Thighs, Outer Thighs, Fat Under Chin) CSQ Item 1 | CSQ - Upper Arms | 88.0 percentage of participants |
| CoolSculpting® Elite System | Percentage of Participants With Satisfied or Very Satisfied on Individual Treated Body Areas (Upper Arms, Inner Thighs, Outer Thighs, Fat Under Chin) CSQ Item 1 | CSQ - Fat Under Chin | 83.3 percentage of participants |