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
|Condition or disease||Intervention/treatment||Phase|
|Lipolysis Cryotherapy Effect||Device: zeltiq Device: electrical stimulation||Not Applicable|
Cryolipolysis is a new concept to reduce fat since Zeltiq machine had been introduced several years ago. Several different trials such as high frequency, liposuction and chemical lipolysis to remove fat had been emerged and tried. Therefore, we would like to know the clinical efficacy of cryolipolysis through comparative experiment with former frequency method on each thigh on healthy Korean women.
Healthy premenopausal women who want to reduce the fat on thigh were included. 28 healthy volunteered women recruited for this study, 15 subjects among participated after interviewing, sampling their metabolic variables at initial visit. A total of 15 subjects would be investigated through food diary(24hour), femoral CT, anthropometric, metabolic variables at initial, 4th, 12th week. Histological examination under skin(initial and 12th week), questionnaire(4th, 12th week) for satisfaction, adverse events would be monitored during 3 month.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Efficacy of Local Fat Reduction on the Thigh of Korean Women Through Cryolipolysis|
|Actual Study Start Date :||July 1, 2010|
|Actual Primary Completion Date :||September 30, 2010|
|Actual Study Completion Date :||October 30, 2010|
Active Comparator: zeltiq
Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.
Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.
Other Name: zeltiq, cryolipolysis
Sham Comparator: electrical stimulation
Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency.
Device: electrical stimulation
Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
Other Name: electrical frequency
- Change in Cross Sectional Area of Fat in Both Thighs [ Time Frame: 4 weeks ]reduction of fat amounts on both thighs measured by computerizing tomography
- Change of the Girths in Both Thighs [ Time Frame: 4 weeks ]Mean differences of the circumferences of both thighs measured by inches
- Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks [ Time Frame: baseline and 12 weeks ]The mean differences of the Cross-Sectional Areas of both Thighs between Baseline and 12 weeks
- Change of Girths in Both Thighs for 12 Weeks [ Time Frame: 12 weeks ]Comparison of circumferences of both thighs for 12 weeks
- Weight Change for 12 Weeks [ Time Frame: baseline and 12 weeks ]Change in weight for 12 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177787
|Korea, Republic of|
|Bariatric clinic/Family medicine, Hong-Ik General Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Kyu Rae Lee, MD.PhD.||Director of Bariatric medicine, Family Medicine, Hong-Ik General Hospital|