Trial Outcomes & Findings for Clinical Efficacy of Cryolipolysis on the Fat of Thigh in Korean Women (NCT NCT01177787)
NCT ID: NCT01177787
Last Updated: 2021-05-14
Results Overview
reduction of fat amounts on both thighs measured by computerizing tomography
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
4 weeks
Results posted on
2021-05-14
Participant Flow
Two arm, but same group. Electrical Stimulation on Rt thigh versus Zeltiq Application on Left thigh.
Participant milestones
| Measure |
Zeltiq on Left/ Electrical Stimulation on Right Thigh
Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.
zeltiq: Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.
Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency.
electrical stimulation: Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
|
|---|---|
|
Clinical Efficacy of Cryolipolysis
STARTED
|
28
|
|
Clinical Efficacy of Cryolipolysis
COMPLETED
|
28
|
|
Clinical Efficacy of Cryolipolysis
NOT COMPLETED
|
0
|
|
Cryolipolysis on Thigh
STARTED
|
28
|
|
Cryolipolysis on Thigh
COMPLETED
|
14
|
|
Cryolipolysis on Thigh
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Zeltiq on Left/ Electrical Stimulation on Right Thigh
Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.
zeltiq: Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.
Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency.
electrical stimulation: Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
|
|---|---|
|
Cryolipolysis on Thigh
Protocol Violation
|
4
|
|
Cryolipolysis on Thigh
Lack of Efficacy
|
9
|
|
Cryolipolysis on Thigh
Lost to Follow-up
|
1
|
Baseline Characteristics
Clinical Efficacy of Cryolipolysis on the Fat of Thigh in Korean Women
Baseline characteristics by cohort
| Measure |
Zeltiq on Left/Electrical Stimulation on Rt
n=14 Participants
Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.
zeltiq: Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.
Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency.
electrical stimulation: Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
28.57 years
STANDARD_DEVIATION 7.81 • n=93 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
South Korea
|
14 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Cross sectional areas of both thighs at initial visit
reduction of fat amounts on both thighs measured by computerizing tomography
Outcome measures
| Measure |
Cross Sectional Area on Left Thigh
n=14 Participants
Cross Sectional Area (mm squares) on Left Thigh by CT
|
Cross Sectional Area on Right Thigh
n=14 Participants
Cross Sectional Area (mm squares) on Rt thigh by CT
|
|---|---|---|
|
Change in Cross Sectional Area of Fat in Both Thighs
|
-420.25 millimeters squares
Standard Deviation 3099.55
|
-28.53 millimeters squares
Standard Deviation 3526.21
|
PRIMARY outcome
Timeframe: 4 weeksMean differences of the circumferences of both thighs measured by inches
Outcome measures
| Measure |
Cross Sectional Area on Left Thigh
n=14 Participants
Cross Sectional Area (mm squares) on Left Thigh by CT
|
Cross Sectional Area on Right Thigh
n=14 Participants
Cross Sectional Area (mm squares) on Rt thigh by CT
|
|---|---|---|
|
Change of the Girths in Both Thighs
|
0.043 inches
Standard Deviation 0.0362
|
-0.15 inches
Standard Deviation 0.1558
|
SECONDARY outcome
Timeframe: baseline and 12 weeksThe mean differences of the Cross-Sectional Areas of both Thighs between Baseline and 12 weeks
Outcome measures
| Measure |
Cross Sectional Area on Left Thigh
n=14 Participants
Cross Sectional Area (mm squares) on Left Thigh by CT
|
Cross Sectional Area on Right Thigh
n=14 Participants
Cross Sectional Area (mm squares) on Rt thigh by CT
|
|---|---|---|
|
Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks
|
1597.8853 mm^2
Standard Deviation 155.7977453
|
1970.0147 mm^2
Standard Deviation 398.15115
|
SECONDARY outcome
Timeframe: 12 weeksComparison of circumferences of both thighs for 12 weeks
Outcome measures
| Measure |
Cross Sectional Area on Left Thigh
n=14 Participants
Cross Sectional Area (mm squares) on Left Thigh by CT
|
Cross Sectional Area on Right Thigh
n=14 Participants
Cross Sectional Area (mm squares) on Rt thigh by CT
|
|---|---|---|
|
Change of Girths in Both Thighs for 12 Weeks
|
-0.45 inch
Standard Deviation 0.17
|
-0.15 inch
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: baseline and 12 weeksChange in weight for 12 weeks
Outcome measures
| Measure |
Cross Sectional Area on Left Thigh
n=14 Participants
Cross Sectional Area (mm squares) on Left Thigh by CT
|
Cross Sectional Area on Right Thigh
n=14 Participants
Cross Sectional Area (mm squares) on Rt thigh by CT
|
|---|---|---|
|
Weight Change for 12 Weeks
|
-0.38 Kg
Standard Deviation 0.81
|
-0.38 Kg
Standard Deviation 0.81
|
Adverse Events
Zeltiq
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Electrical Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zeltiq
n=14 participants at risk
Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.
|
Electrical Stimulation
n=14 participants at risk
The radio frequency method was applied on right thigh (control side) as sham procedure for 30 minutes through 3000 Hz- amplitude modulated frequency at once.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Minor dermatological compliaint
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Minor Dermatologic complaint
|
14.3%
2/14 • Number of events 2
|
0.00%
0/14
|
|
Gastrointestinal disorders
Minor generalized complaints
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
Additional Information
Dr. Kyu Rae LeeMD.PhD.
Gachon University of Medicine and Science
Phone: 8232-770-1215
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place