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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Efficacy of Local Fat Reduction on the Thigh of Korean Women Through Cryolipolysis

Conditions
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Lipolysis, Cryotherapy Effect

Intervention / Treatment
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* Device: zeltiq
* Device: electrical stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: zeltiq<br>Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine. | Device: zeltiq<br>* Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.<br>* Other names: zeltiq, cryolipolysis;|
| Sham Comparator: electrical stimulation<br>Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency. | Device: electrical stimulation<br>* Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.<br>* Other names: electrical frequency;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cross Sectional Area of Fat in Both Thighs | reduction of fat amounts on both thighs measured by computerizing tomography | 4 weeks | 
| Change of the Girths in Both Thighs | Mean differences of the circumferences of both thighs measured by inches | 4 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryolipolysis, fat, thigh, Korean women