Body Fat Disorder
Conditions
Brief summary
To evaluate the safety and effectiveness of the Allergan CoolSculpting® system using CoolAdvantage applicators for non-invasive subcutaneous fat reduction of the upper arms and inner thighs in participants of Chinese descent.
Interventions
DEVICECoolSculpting® System
Each participant underwent a single treatment session that was comprised of timed segments of cooling followed by 2 minutes of manual massage.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. Blinding will only be employed for photograph review by an independent panel of physician reviewers with expertise in the areas of dermatology and/or plastic surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant (healthy volunteers) has read and signed the study written informed consent form (ICF) * 1st or 2nd generation, non-mixed race, Chinese descent. * Participant has clearly visible and palpable fat on the left and right lower aspects of the upper arms and/or left and right inner thighs, which in the investigator's opinion is appropriate and may benefit from the treatment. * Participant has not had weight change fluctuations exceeding 4.5 kilograms (kg) (or 5% of body weight) in the preceding month. * Participant has a body mass index (BMI) of ≥ 18.5 to ≤ 30. A BMI is defined as weight in kilograms divided by height in meters squared (kg/m\^2). * Participant agrees to maintain weight (i.e., 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 (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or immediately adjacent to the area of intended treatment. * Participant has a history of prior surgery or scar tissue on the arms and/or inner thighs 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 oral or subcutaneous anticoagulants, or is taking any medication that in the investigator's opinion may significantly increase the participant's risk of bruising. * Participant with a history of carpal tunnel syndrome, compartment syndrome, or deep vein thrombosis in the upper or lower extremities. * Participant is currently taking or has taken diet pills or weight control supplements within the past 6 months. * Participant has any dermatological conditions, such as moderate to excessive skin laxity, infection, open wound, or scars 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 is pregnant or intending to become pregnant in the next 3 months. * 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 (e.g., cortisone, heparin, insulin) within the past 6 months. * Participant with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol. * Participant with impaired peripheral circulation in the area to be treated. * Participant with neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy. * Participant with impaired skin sensation. * Participant with a history of hernia in or adjacent to the treatment area(s) site. * Participant with a skin condition such as eczema, dermatitis, or rashes in the area to be treated. * 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 Arms With Correct Identification of Baseline Versus 12-week Treatment Images of the Upper Arms by at Least Two Out of Three Blinded, Independent Reviewers | Baseline (Day 1) to Week 12 | Baseline versus 12-week images of the participants' left and right upper arms were assessed separately by the reviewers. Success was defined as at least 75% correct identification of the pre-treatment images of the upper arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Thighs With Correct Identification of Baseline Versus 12-week Treatment Images of the Inner Thighs by at Least Two Out of Three Blinded, Independent Reviewers | Baseline (Day 1) to Week 12 | Baseline versus 12-week images of the participants' left and right thighs were assessed separately by the reviewers. Success was defined as at least 75% correct identification of the pre-treatment images of the inner thighs. |
| Number of Participants With a Response of 'Satisfied' or 'Very Satisfied' for Question 1 (Overall Satisfaction) on the CoolSculpting Participant Questionnaire at the 12-week Visit for the Upper Arms | Week 12 | Participants were asked to complete a survey upon completing the treatment to assess their level of satisfaction with the treatment. Participants selected one of five options: 'very satisfied', 'satisfied', 'neither satisfied nor dissatisfied', 'dissatisfied', or 'very dissatisfied'. |
| Number of Participants With a Response of 'Satisfied' or 'Very Satisfied' for Question 1 (Overall Satisfaction) on the CoolSculpting Participant Questionnaire at the 12-week Visit for the Inner Thighs | Week 12 | Participants were asked to complete a survey upon completing the treatment to assess their level of satisfaction with the treatment. Participants selected one of five options: 'very satisfied', 'satisfied', 'neither satisfied nor dissatisfied', 'dissatisfied', or 'very dissatisfied'. |
| Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Upper Arms | Baseline (Day 1) to Week 12 | Caliper measurements of the treatment areas were taken at baseline and at 12-weeks post treatment. After the treatment area was identified and marked, the thickness of the fat layer was measured using a caliper at the middle of the fat bulge. For each treatment area, three measurements were taken and recorded. The average of the three measurements was calculated. A negative change from baseline indicates improvement. |
| Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Inner Thighs | Baseline (Day 1) to Week 12 | Caliper measurements of the treatment areas were taken at baseline and at 12-weeks post treatment. After the treatment area was identified and marked, the thickness of the fat layer was measured using a caliper at the middle of the fat bulge. For each treatment area, three measurements were taken and recorded. The average of the three measurements was calculated. A negative change from baseline indicates improvement. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CoolSculpting® System Participants underwent a single CoolSculpting® treatment session on Day 1 that was comprised of timed segments of cooling followed by 2 minutes of manual massage. Each treated arm had up to two timed segments (or cycles) in the treatment session, each treated thigh had one timed segment (or cycle) in the treatment session. | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Screen Failure | 1 |
Baseline characteristics
| Characteristic | CoolSculpting® System |
|---|---|
| Age, Continuous | 36.1 years STANDARD_DEVIATION 9.68 |
| Race/Ethnicity, Customized First Generation, Non-Mixed Chinese | 22 Participants |
| Race/Ethnicity, Customized Second Generation, Non-Mixed Chinese | 27 Participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
Primary
Percentage of Arms With Correct Identification of Baseline Versus 12-week Treatment Images of the Upper Arms by at Least Two Out of Three Blinded, Independent Reviewers
Baseline versus 12-week images of the participants' left and right upper arms were assessed separately by the reviewers. Success was defined as at least 75% correct identification of the pre-treatment images of the upper arms.
Time frame: Baseline (Day 1) to Week 12
Population: Per Protocol Population, consisted of all treated participants followed for 12 weeks and with weight change of no more than 5% of total body weight at the time the 12-week images were taken. Overall number analyzed are the number of participants and number of arms treated per protocol with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoolSculpting® System | Percentage of Arms With Correct Identification of Baseline Versus 12-week Treatment Images of the Upper Arms by at Least Two Out of Three Blinded, Independent Reviewers | 76.4 percentage of arms |
Secondary
Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Inner Thighs
Caliper measurements of the treatment areas were taken at baseline and at 12-weeks post treatment. After the treatment area was identified and marked, the thickness of the fat layer was measured using a caliper at the middle of the fat bulge. For each treatment area, three measurements were taken and recorded. The average of the three measurements was calculated. A negative change from baseline indicates improvement.
Time frame: Baseline (Day 1) to Week 12
Population: Per Protocol Population consisted of all treated participants followed for 12 weeks and with weight change of no more than 5% of total body weight at the time the 12-week images were taken. Overall number analyzed are the number of participants and number of thighs treated per protocol available for analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CoolSculpting® System | Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Inner Thighs | Baseline (Day 1) | 32.2 mm | Standard Deviation 9.28 |
| CoolSculpting® System | Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Inner Thighs | Change from Baseline to Week 12 | -4.3 mm | Standard Deviation 12.44 |
Secondary
Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Upper Arms
Caliper measurements of the treatment areas were taken at baseline and at 12-weeks post treatment. After the treatment area was identified and marked, the thickness of the fat layer was measured using a caliper at the middle of the fat bulge. For each treatment area, three measurements were taken and recorded. The average of the three measurements was calculated. A negative change from baseline indicates improvement.
Time frame: Baseline (Day 1) to Week 12
Population: Per Protocol Population consisted of all treated participants followed for 12 weeks and with weight change of no more than 5% of total body weight at the time the 12-week images were taken. Overall number analyzed are the number of participants and number of arms treated per protocol with data available for analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CoolSculpting® System | Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Upper Arms | Baseline (Day 1) | 26.7 millimeter (mm) | Standard Deviation 5.54 |
| CoolSculpting® System | Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Upper Arms | Change from Baseline to Week 12 | -7.0 millimeter (mm) | Standard Deviation 5.72 |
Secondary
Number of Participants With a Response of 'Satisfied' or 'Very Satisfied' for Question 1 (Overall Satisfaction) on the CoolSculpting Participant Questionnaire at the 12-week Visit for the Inner Thighs
Participants were asked to complete a survey upon completing the treatment to assess their level of satisfaction with the treatment. Participants selected one of five options: 'very satisfied', 'satisfied', 'neither satisfied nor dissatisfied', 'dissatisfied', or 'very dissatisfied'.
Time frame: Week 12
Population: Per Protocol Population consisted of all treated participants followed for 12 weeks and with weight change of no more than 5% of total body weight at the time the 12-week images were taken. Number of participants analyzed is the number of participants with thighs treated with data available for analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CoolSculpting® System | Number of Participants With a Response of 'Satisfied' or 'Very Satisfied' for Question 1 (Overall Satisfaction) on the CoolSculpting Participant Questionnaire at the 12-week Visit for the Inner Thighs | 26 Participants |
Secondary
Number of Participants With a Response of 'Satisfied' or 'Very Satisfied' for Question 1 (Overall Satisfaction) on the CoolSculpting Participant Questionnaire at the 12-week Visit for the Upper Arms
Participants were asked to complete a survey upon completing the treatment to assess their level of satisfaction with the treatment. Participants selected one of five options: 'very satisfied', 'satisfied', 'neither satisfied nor dissatisfied', 'dissatisfied', or 'very dissatisfied'.
Time frame: Week 12
Population: Per Protocol Population consisted of all treated participants followed for 12 weeks and with weight change of no more than 5% of total body weight at the time the 12-week images were taken. Number of participants analyzed are the number of participants with arms treated with data available for analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CoolSculpting® System | Number of Participants With a Response of 'Satisfied' or 'Very Satisfied' for Question 1 (Overall Satisfaction) on the CoolSculpting Participant Questionnaire at the 12-week Visit for the Upper Arms | 22 Participants |
Secondary
Percentage of Thighs With Correct Identification of Baseline Versus 12-week Treatment Images of the Inner Thighs by at Least Two Out of Three Blinded, Independent Reviewers
Baseline versus 12-week images of the participants' left and right thighs were assessed separately by the reviewers. Success was defined as at least 75% correct identification of the pre-treatment images of the inner thighs.
Time frame: Baseline (Day 1) to Week 12
Population: Per Protocol Population consisted of all treated participants followed for 12 weeks and with weight change of no more than 5% of total body weight at the time the 12-week images were taken. Overall number analyzed are the number of participants and number of thighs treated per protocol with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoolSculpting® System | Percentage of Thighs With Correct Identification of Baseline Versus 12-week Treatment Images of the Inner Thighs by at Least Two Out of Three Blinded, Independent Reviewers | 70.0 percentage of thighs |