Clinical Efficacy of Cryolipolysis on the Fat of Thigh in Korean Women
Recruitment status was: Active, not recruiting
Device: electrical stimulation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Efficacy of Local Fat Reduction on the Thigh of Korean Women Through Cryolipolysis|
- clinical efficacy of fat reduction on thigh by femoral CT [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]As the difference of fat amounts on both thigh measured by femoral CT will be evaluated, fat amounts, metabolic variables, gross appearance on ipsilateral thigh by cryolipolysis (Zeltiq) would be compared to those on controlateral thigh by frequency method for 4 weeks.
- clinical efficacy/safety of fat reduction through cryolipolysis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Histological examination under skin biopsy, and gross appearance, and metabolic variables, and fat amounts by femoral CT, and questionnaire for satisfaction will be compared for past 3 months
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||October 2010|
|Estimated Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177787
|Korea, Republic of|
|Gachon University of Medicine and Science|
|Incheon, Kyunggi, Korea, Republic of, 405-760|
|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|