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Clinical Efficacy of Cryolipolysis on the Fat of Thigh in Korean Women

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ClinicalTrials.gov Identifier: NCT01177787
Recruitment Status : Completed
First Posted : August 9, 2010
Results First Posted : May 14, 2021
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Wonik Trade Company, Korea

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lipolysis
Cryotherapy Effect
Interventions Device: zeltiq
Device: electrical stimulation
Enrollment 28
Recruitment Details  
Pre-assignment Details Two arm, but same group. Electrical Stimulation on Rt thigh versus Zeltiq Application on Left thigh.
Arm/Group Title Zeltiq on Left/ Electrical Stimulation on Right Thigh
Hide Arm/Group Description

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.

Period Title: Clinical Efficacy of Cryolipolysis
Started 28
Completed 28
Not Completed 0
Period Title: Cryolipolysis on Thigh
Started 28
Completed 14
Not Completed 14
Reason Not Completed
Protocol Violation             4
Lack of Efficacy             9
Lost to Follow-up             1
Arm/Group Title Zeltiq on Left/Electrical Stimulation on Rt
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
A total of 14 subjects were completed this study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
28.57  (7.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
14
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
American Indian or Alaska Native
0
   0.0%
Asian
14
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
South Korea Number Analyzed 14 participants
14
1.Primary Outcome
Title Change in Cross Sectional Area of Fat in Both Thighs
Hide Description reduction of fat amounts on both thighs measured by computerizing tomography
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Cross sectional areas of both thighs at initial visit
Arm/Group Title Cross Sectional Area on Left Thigh Cross Sectional Area on Right Thigh
Hide Arm/Group Description:
Cross Sectional Area (mm squares) on Left Thigh by CT
Cross Sectional Area (mm squares) on Rt thigh by CT
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: millimeters squares
-420.25  (3099.55) -28.53  (3526.21)
2.Primary Outcome
Title Change of the Girths in Both Thighs
Hide Description Mean differences of the circumferences of both thighs measured by inches
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zeltiq on Left Electrical Stimulation on Right Side Thigh
Hide Arm/Group Description:
Cryolipolysis using by Zeltiq for 1 hour
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
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: inches
0.043  (0.0362) -0.15  (0.1558)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zeltiq on Left
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.503
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.669
Parameter Dispersion
Type: Standard Deviation
Value: 0.03
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks
Hide Description The mean differences of the Cross-Sectional Areas of both Thighs between Baseline and 12 weeks
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title The Change of Fat on Left Thigh Between Baseline and 12 Weeks The Change of Fat Right Thigh Between Baseline and 12 Weeks
Hide Arm/Group Description:
Comparison of Cross-Sectional Area on Left Thigh by CT between baseline and 12 weeks
Comparison of Cross-Sectional areas on Right thigh by CT between baseline and 12 weeks
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: mm^2
1597.8853  (155.7977453) 1970.0147  (398.15115)
4.Secondary Outcome
Title Change of Girths in Both Thighs for 12 Weeks
Hide Description Comparison of circumferences of both thighs for 12 weeks
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zeltiq Electrical Stimulation
Hide Arm/Group Description:
zeltiq: Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.
electrical stimulation: Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: inch
-0.45  (0.17) -0.15  (0.29)
5.Secondary Outcome
Title Weight Change for 12 Weeks
Hide Description Change in weight for 12 weeks
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zeltiq Electrical Stimulation
Hide Arm/Group Description:
zeltiq: Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.
electrical stimulation: Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Kg
-0.38  (0.81) -0.38  (0.81)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zeltiq Electrical Stimulation
Hide Arm/Group Description Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine. 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.
All-Cause Mortality
Zeltiq Electrical Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/14 (0.00%)    
Hide Serious Adverse Events
Zeltiq Electrical Stimulation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/14 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zeltiq Electrical Stimulation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/14 (28.57%)      0/14 (0.00%)    
Gastrointestinal disorders     
Minor generalized complaints * [1]  1/14 (7.14%)  1 0/14 (0.00%)  0
Skin and subcutaneous tissue disorders     
Minor dermatological compliaint * [2]  1/14 (7.14%)  1 0/14 (0.00%)  0
Minor Dermatologic complaint * [3]  2/14 (14.29%)  2 0/14 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
blood tinged stool
[2]
pain
[3]
bruits
In the beginning, because this study has some drawback for small sample size , and secondly, although the novel treatment process for radio frequency method included more than 6 sessions, it was performed just at once as sham procedure in this study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kyu Rae LeeMD.PhD.
Organization: Gachon University of Medicine and Science
Phone: 8232-770-1215
EMail: baria07@daum.net
Publications:
KR Lee. Clinical Efficacy of Fat Reduction on the Thigh of Korean Women through CryolipolysisJ Obes Weight Loss Ther 2013, 3:6
Layout table for additonal information
Responsible Party: Wonik Trade Company, Korea
ClinicalTrials.gov Identifier: NCT01177787    
Other Study ID Numbers: Wonik201007
First Submitted: July 28, 2010
First Posted: August 9, 2010
Results First Submitted: August 28, 2020
Results First Posted: May 14, 2021
Last Update Posted: May 14, 2021