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

Not Applicable

Completed

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
zeltiq	zeltiq	Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.
electrical stimulation	electrical stimulation	Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency.

Primary Outcome Measures

Name	Time	Method
Change in Cross Sectional Area of Fat in Both Thighs	4 weeks	reduction of fat amounts on both thighs measured by computerizing tomography
Change of the Girths in Both Thighs	4 weeks	Mean differences of the circumferences of both thighs measured by inches

Secondary Outcome Measures

Name	Time	Method
Weight Change for 12 Weeks	baseline and 12 weeks	Change in weight for 12 weeks
Change of Girths in Both Thighs for 12 Weeks	12 weeks	Comparison of circumferences of both thighs for 12 weeks
Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks	baseline and 12 weeks	The mean differences of the Cross-Sectional Areas of both Thighs between Baseline and 12 weeks