Trial Outcomes & Findings for CoolSculpting® the Upper Arms and Inner Thighs in Participants of Chinese Descent (XinCOOL) (NCT NCT04142450)
NCT ID: NCT04142450
Last Updated: 2021-04-01
Results Overview
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.
COMPLETED
NA
50 participants
Baseline (Day 1) to Week 12
2021-04-01
Participant Flow
Participant milestones
| Measure |
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.
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Overall Study
STARTED
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50
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Overall Study
Safety Population
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49
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Overall Study
COMPLETED
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48
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
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.
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Overall Study
Screen Failure
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1
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
CoolSculpting® the Upper Arms and Inner Thighs in Participants of Chinese Descent (XinCOOL)
Baseline characteristics by cohort
| Measure |
CoolSculpting® System
n=49 Participants
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.
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Age, Continuous
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36.1 years
STANDARD_DEVIATION 9.68 • n=93 Participants
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Sex: Female, Male
Female
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48 Participants
n=93 Participants
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Sex: Female, Male
Male
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1 Participants
n=93 Participants
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Race/Ethnicity, Customized
First Generation, Non-Mixed Chinese
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22 Participants
n=93 Participants
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Race/Ethnicity, Customized
Second Generation, Non-Mixed Chinese
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27 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: 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.
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.
Outcome measures
| Measure |
CoolSculpting® System
n=72 arms
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.
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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
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76.4 percentage of arms
Interval 64.9 to 85.6
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SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: 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.
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.
Outcome measures
| Measure |
CoolSculpting® System
n=40 thighs
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.
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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
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70.0 percentage of thighs
Interval 53.5 to 83.4
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SECONDARY outcome
Timeframe: Week 12Population: 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.
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'.
Outcome measures
| Measure |
CoolSculpting® System
n=36 Participants
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.
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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
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22 Participants
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SECONDARY outcome
Timeframe: Week 12Population: 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.
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'.
Outcome measures
| Measure |
CoolSculpting® System
n=40 Participants
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.
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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
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26 Participants
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SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: 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.
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.
Outcome measures
| Measure |
CoolSculpting® System
n=72 arms
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.
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Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Upper Arms
Baseline (Day 1)
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26.7 millimeter (mm)
Standard Deviation 5.54
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Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Upper Arms
Change from Baseline to Week 12
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-7.0 millimeter (mm)
Standard Deviation 5.72
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SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: 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.
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.
Outcome measures
| Measure |
CoolSculpting® System
n=80 thighs
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.
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Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Inner Thighs
Baseline (Day 1)
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32.2 mm
Standard Deviation 9.28
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Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Inner Thighs
Change from Baseline to Week 12
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-4.3 mm
Standard Deviation 12.44
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Adverse Events
CoolSculpting® System
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER