Trial Outcomes & Findings for Subcutaneous Fat Reduction in the Submental Area (NCT NCT02298322)
NCT ID: NCT02298322
Last Updated: 2020-09-24
Results Overview
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.
COMPLETED
NA
60 participants
Time of enrollment through12 week post-final treatment follow-up
2020-09-24
Participant Flow
Participant milestones
| Measure |
CoolSculpting Treatment
Subjects treated with Coolsculpting for subcutaneous fat reduction in the submental area
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subcutaneous Fat Reduction in the Submental Area
Baseline characteristics by cohort
| Measure |
CoolSculpting Treatment
n=60 Participants
Subjects treated with CoolSculpting for fat reduction in the submittal area
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time of enrollment through12 week post-final treatment follow-upPopulation: As-treated population of 60 subjects who received CoolSculpting treatment for subcutaneous fat reduction 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.
Outcome measures
| Measure |
CoolSculpting Treatment
n=60 Participants
Subjects treated with CoolSculpting for subcutaneous fat reduction in the submental area
|
|---|---|
|
Safety of CoolScupting in the Submental Area
|
4 incidence of device- and/or procedure AE
|
PRIMARY outcome
Timeframe: 12 week post-final-treatmentPopulation: Subjects included in the analysis group (58) received full treatment; treatment was interrupted for 2 subjects not included in this population.
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.
Outcome measures
| Measure |
CoolSculpting Treatment
n=58 photo pairs
Subjects treated with CoolSculpting for subcutaneous fat reduction in the submental area
|
|---|---|
|
Percentage of Correct Identification of Pre-treatment Photographs
|
91.4 percentage of correcty identified photos
|
SECONDARY outcome
Timeframe: 12 weeks post-final treatmentPopulation: Evaluable ultrasound images were available for 57 of the 59 subjects completing the 12 week follow-up visit.
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.
Outcome measures
| Measure |
CoolSculpting Treatment
n=57 Participants
Subjects treated with CoolSculpting for subcutaneous fat reduction in the submental area
|
|---|---|
|
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 outcome
Timeframe: 12 weeks post-final treatmentPopulation: 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.
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.
Outcome measures
| Measure |
CoolSculpting Treatment
n=60 Participants
Subjects treated with CoolSculpting for subcutaneous fat reduction in the submental area
|
|---|---|
|
Subject Satisfaction With CoolScupting in the Submental Area
Feel less self-conscious about chin fat
|
43 Participants
|
|
Subject Satisfaction With CoolScupting in the Submental Area
Visible/Very Visible Fat Reduction
|
46 Participants
|
|
Subject Satisfaction With CoolScupting in the Submental Area
Satisfied/VerySatisfied with CoolSculpting
|
50 Participants
|
|
Subject Satisfaction With CoolScupting in the Submental Area
Procedure was Very Comfortable/Comfortable
|
45 Participants
|
|
Subject Satisfaction With CoolScupting in the Submental Area
Strongly Agree/Agree Procedure made more youthful
|
30 Participants
|
|
Subject Satisfaction With CoolScupting in the Submental Area
Strongly Agree/Agree chin looked more toned
|
45 Participants
|
|
Subject Satisfaction With CoolScupting in the Submental Area
Strongly Agree/Agree appearance has improved
|
46 Participants
|
|
Subject Satisfaction With CoolScupting in the Submental Area
Effect from procedure More Than Expected/Expected
|
40 Participants
|
|
Subject Satisfaction With CoolScupting in the Submental Area
Would recommend procedure to a friend
|
48 Participants
|
Adverse Events
CoolSculpting Treatment
Serious adverse events
| Measure |
CoolSculpting Treatment
n=60 participants at risk
Subjects treated with Coolsculpting for subcutaneous fat reduction in the submental area
|
|---|---|
|
Gastrointestinal disorders
Food poisoning
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
Other adverse events
| Measure |
CoolSculpting Treatment
n=60 participants at risk
Subjects treated with Coolsculpting for subcutaneous fat reduction in the submental area
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Pinched nerve
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
Infections and infestations
Upper respiratory infection
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
Infections and infestations
Influenza
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
Musculoskeletal and connective tissue disorders
Broken finger
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
Infections and infestations
Pneumonia
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
Musculoskeletal and connective tissue disorders
Torn meniscus
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
General disorders
Hives
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
General disorders
Cold
|
8.3%
5/60 • Number of events 5 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
Skin and subcutaneous tissue disorders
Prolonged erythema
|
3.3%
2/60 • Number of events 2 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
General disorders
Cold sore
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
Skin and subcutaneous tissue disorders
Hyper pigmentation
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
Infections and infestations
Breast infection
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
General disorders
Back of throat fullness sensation
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
Gastrointestinal disorders
Food Poisoning
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
|
Skin and subcutaneous tissue disorders
Skin cancer
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from enrollment through the 12-week final follow-up visit.
Anticipated deaths = 0 participants Unanticipated deaths = 0 participants
|
Additional Information
Kerrie Jiang, Executive Director, Regulatory, Clinical and Medical Affairs
Zeltiq Aesthetics, Inc. an Allergan Affiliate
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place