Clinical Efficacy of Cryolipolysis on the Fat of Thigh in Korean Women
This trial is active, not recruiting.
|Treatments||zeltiq, electrical stimulation|
|Phase||phase 1/phase 2|
|Sponsor||Wonik Trade Company, Korea|
|Start date||July 2010|
|End date||August 2010|
|Trial size||15 participants|
|Trial identifier||NCT01177787, Wonik201007|
The aim of this study is to evaluate the clinical efficacy of reduction of local fat on ipsilateral thigh through cryolipolysis (zeltiq) and controlateral thigh using by amplitude modulated frequency (conventional) method.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||factorial assignment|
clinical efficacy of fat reduction on thigh by femoral CT
time frame: 1 month
clinical efficacy/safety of fat reduction through cryolipolysis
time frame: 3 months
Female participants from 20 years up to 50 years old.
Inclusion Criteria: - premenopausal healthy women - subjects with body mass index >= 18. - subjects with visible fat on both thigh - subjects to understand and agree to this study protocol Exclusion Criteria: - subjects with cryoglobulinemia, cold urticaria, or paroxysmal cold hemogobulinemia - subjects with pregnancy or lactation within 6 months or next 3 months - subjects with any laboratory, or metabolic abnormalities - uncooperative subjects to comply with the study protocol - women taking any medication over 6 months - subjects with menstrual irregularities - subjects to change over 10% of the former weight within the past 6 months - any procedure such as liposuction, or another surgical procedure or mesotherapy to reduce fat within 6 months - subjects with any dermatologic abnormalities on the target area (thigh) - subjects with any injection into the area of intended treatment (e.g. cortisone) within 6 months
|Official title||Clinical Efficacy of Local Fat Reduction on the Thigh of Korean Women Through Cryolipolysis|
|Principal investigator||Kyu Rae Lee, MD.PhD.|
|Description||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.|
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