Trial Outcomes & Findings for Non-invasive Cooling of Subcutaneous Fat (NCT NCT00762307)
NCT ID: NCT00762307
Last Updated: 2021-06-09
Results Overview
The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group.
COMPLETED
NA
60 participants
Baseline and 6 months
2021-06-09
Participant Flow
Participant milestones
| Measure |
Treatment Group 1
Cooling Intensity Factor = 33 Duration = 60 minutes
Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
|
Treatment Group 2
Cooling Intensity Factor = 37 Duration = 30 minutes
Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
|
Treatment Group 3
Cooling Intensity Factor = 37 Duration = 45 minutes
Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
|
Treatment Group 4
Cooling Intensity Factor = 42 Cooling Duration = 30 minutes
Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
11
|
11
|
10
|
|
Overall Study
COMPLETED
|
26
|
11
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-invasive Cooling of Subcutaneous Fat
Baseline characteristics by cohort
| Measure |
Treatment Group 1
n=28 Participants
Subjects in Treatment Group 1 were treated using a Cooling Intensity Factor (CIF) of 33 for 60 minutes.
|
Treatment Group 2
n=11 Participants
Subjects in Treatment Group 2 were treated using CIF 37 for 30 minutes.
|
Treatment Group 3
n=11 Participants
Subjects in Treatment Group 3 were treated using CIF 37 for 45 minutes.
|
Treatment Group 4
n=10 Participants
Subjects in Treatment Group 4 were treated using CIF 42 for 30 minutes.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
9 Participants
n=157 Participants
|
58 Participants
n=390 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
|
Age, Continuous
|
41 years
n=99 Participants
|
44 years
n=107 Participants
|
44 years
n=206 Participants
|
49 years
n=157 Participants
|
44 years
n=390 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
19 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
41 Participants
n=390 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
11 participants
n=107 Participants
|
11 participants
n=206 Participants
|
10 participants
n=157 Participants
|
60 participants
n=390 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: The population includes only subjects with evaluable ultrasound data ( \>3 valid images at 6 month follow up visit). Group 1 exclusions: 2 Lost To Follow Up and 6 not evaluable; Group 2 exclusions: 1 not evaluable; Group 3 exclusions: 3 not evaluable; Group 4 exclusions: 1 not evaluable and 1 withdrawn from study by Investigator.
The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group.
Outcome measures
| Measure |
All Groups
n=46 Participants
All subjects treated in Groups 1, 2, 3 and 4 are combined for this analysis.
|
Group 1
n=20 Participants
CIF 33 for 60 minutes
|
Group 2
n=10 Participants
CIF 37 30 minute duration
|
Group 3
n=8 Participants
CIF 37 duration 45 minutes
|
Group 4
n=8 Participants
CIF 42 30 duration 30 minutes
|
|---|---|---|---|---|---|
|
Change in Fat Layer Thickness of the Treated Flank
|
-18.7 percent fat layer change
Standard Error 1.9
|
-22.6 percent fat layer change
Standard Error 3.4
|
-17.8 percent fat layer change
Standard Error 3.6
|
-17.5 percent fat layer change
Standard Error 2.3
|
-11.1 percent fat layer change
Standard Error 3.8
|
PRIMARY outcome
Timeframe: 6 months post-treatment follow-up visitPopulation: 56 subjects completed the questionnaire; 2 subjects were LTFU, 1 subject failed to complete the questionnaire and 1 subject was withdrawn from the study by the Investigator. Four (4) subjects did not respond to one question on the questionnaire; 1 subject did not respond to another question on the questionnaire.
Subject satisfaction as determined by the completion of a questionnaire at the 6 month follow-up visit, and, as requested, any other follow-up visits.
Outcome measures
| Measure |
All Groups
n=56 Participants
All subjects treated in Groups 1, 2, 3 and 4 are combined for this analysis.
|
Group 1
n=25 Participants
CIF 33 for 60 minutes
|
Group 2
n=11 Participants
CIF 37 30 minute duration
|
Group 3
n=11 Participants
CIF 37 duration 45 minutes
|
Group 4
n=9 Participants
CIF 42 30 duration 30 minutes
|
|---|---|---|---|---|---|
|
Percentage of Subjects Expressing Satisfaction With the Procedure
Overall satisfaction with treatment experience
|
82.1 percent positive responses
Standard Deviation 5.1
|
84 percent positive responses
Standard Deviation 7.3
|
81.8 percent positive responses
Standard Deviation 11.6
|
90.9 percent positive responses
Standard Deviation 8.7
|
66.7 percent positive responses
Standard Deviation 15.7
|
|
Percentage of Subjects Expressing Satisfaction With the Procedure
Agree there is a change to the treated area
|
76.3 percent positive responses
Standard Deviation 5.7
|
84 percent positive responses
Standard Deviation 7.3
|
54.5 percent positive responses
Standard Deviation 15.0
|
100 percent positive responses
Standard Deviation 0
|
55.6 percent positive responses
Standard Deviation 16.6
|
|
Percentage of Subjects Expressing Satisfaction With the Procedure
Agree change to treated area was improvement
|
78.9 percent positive responses
Standard Deviation 5.7
|
95.2 percent positive responses
Standard Deviation 4.7
|
63.6 percent positive responses
Standard Deviation 14.5
|
81.8 percent positive responses
Standard Deviation 11.6
|
55.6 percent positive responses
Standard Deviation 16.6
|
|
Percentage of Subjects Expressing Satisfaction With the Procedure
Expectations were met or exceeded
|
73.2 percent positive responses
Standard Deviation 5.9
|
72 percent positive responses
Standard Deviation 9.0
|
78.6 percent positive responses
Standard Deviation 12.4
|
81.8 percent positive responses
Standard Deviation 11.6
|
66.7 percent positive responses
Standard Deviation 15.7
|
|
Percentage of Subjects Expressing Satisfaction With the Procedure
Discomfort was no greater than expected
|
98.2 percent positive responses
Standard Deviation 1.8
|
100 percent positive responses
Standard Deviation 0
|
90.9 percent positive responses
Standard Deviation 8.7
|
100 percent positive responses
Standard Deviation 0
|
100 percent positive responses
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: The analysis population included subjects who had evaluable photos from baseline and the 6 month final follow-up visit. Subjects who did not maintain their weight per protocol requirements were excluded from analysis.
Change in the treated vs. untreated areas will be assessed for changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the control and treated flanks. Reviewers will be practicing dermatologists. All reviewers will be blinded to post-treatment vs. baseline and/or untreated flank. 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. Results reflect the percentage of correctly identified images.
Outcome measures
| Measure |
All Groups
n=31 Participants
All subjects treated in Groups 1, 2, 3 and 4 are combined for this analysis.
|
Group 1
n=11 Participants
CIF 33 for 60 minutes
|
Group 2
n=8 Participants
CIF 37 30 minute duration
|
Group 3
n=6 Participants
CIF 37 duration 45 minutes
|
Group 4
n=6 Participants
CIF 42 30 duration 30 minutes
|
|---|---|---|---|---|---|
|
Percentage of Correctly Identified Pre-treatment Photographs
|
91.9 percent correctly identified images
Standard Error 5.2
|
90.5 percent correctly identified images
Standard Error 7.6
|
100 percent correctly identified images
Standard Error 0
|
100 percent correctly identified images
Standard Error 0
|
83.3 percent correctly identified images
Standard Error 15.2
|
Adverse Events
Treatment Group 1
Treatment Group 2
Treatment Group 3
Treatment Group 4
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group 1
n=28 participants at risk
Subjects from Group 1 were treated using a CIF of 33 for 60 minutes in duration.
|
Treatment Group 2
n=11 participants at risk
Subjects from Group 2 were treated using a CIF of 37 for 30 minutes in duration.
|
Treatment Group 3
n=11 participants at risk
Subjects in Treatment Group 3 were treated using a CIF of 37 for 45 minutes in duration.
|
Treatment Group 4
n=10 participants at risk
Subjects in Treatment Group 4 were treated using a CIF of 42 for 30 minutes in duration.
|
|---|---|---|---|---|
|
General disorders
Pain
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected from the time of enrollment though the 6 month follow-up visit, a time period of approximately 8 months.
|
0.00%
0/11 • Adverse event data were collected from the time of enrollment though the 6 month follow-up visit, a time period of approximately 8 months.
|
0.00%
0/11 • Adverse event data were collected from the time of enrollment though the 6 month follow-up visit, a time period of approximately 8 months.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from the time of enrollment though the 6 month follow-up visit, a time period of approximately 8 months.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/28 • Adverse event data were collected from the time of enrollment though the 6 month follow-up visit, a time period of approximately 8 months.
|
0.00%
0/11 • Adverse event data were collected from the time of enrollment though the 6 month follow-up visit, a time period of approximately 8 months.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected from the time of enrollment though the 6 month follow-up visit, a time period of approximately 8 months.
|
0.00%
0/10 • Adverse event data were collected from the time of enrollment though the 6 month follow-up visit, a time period of approximately 8 months.
|
|
General disorders
Muscle spasm
|
0.00%
0/28 • Adverse event data were collected from the time of enrollment though the 6 month follow-up visit, a time period of approximately 8 months.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected from the time of enrollment though the 6 month follow-up visit, a time period of approximately 8 months.
|
0.00%
0/11 • Adverse event data were collected from the time of enrollment though the 6 month follow-up visit, a time period of approximately 8 months.
|
0.00%
0/10 • Adverse event data were collected from the time of enrollment though the 6 month follow-up visit, a time period of approximately 8 months.
|
Additional Information
Kerrie Jiang, Director of Regulatory, Clinical and Medical Affairs
Zeltiq Aesthetics
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place