Cryolipolysis Induced Gluteal Fat Change

Study Overview
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Brief Summary
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There was no difference in efficacy in removal of local fat on thigh by cryolipolysis through Zeltiq machine. Cryolipolysis was found to be safe for 12 week clinical trial.

Detailed Description
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this study is conducted to investigate the clinical efficacy and safety of cryolipolysis on fat removal of thigh through cryolipolysis. Healthy premenopausal volunteered women had been conducted to assess their anthropometrical, social, and cardio-metabolic, and femoral fat amount by computer tomography, and adverse events at initial, 4 week, 12 week visit.

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

Conditions
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Body Weight Changes

Intervention / Treatment
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* Device: zeltiq
* Device: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pre-menopausal 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 the counter/herbal supplements to regulate weight or fat mass 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 areas (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: 18 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: Sequential Assignment
Interventional Model Description: the sequential split-body trials
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cryolipolysis machine on Left inner thigh<br>Zeltiq machine as intervention procedure was carried out on left inner thigh (treated side) for 1 hour through cool sculpting procedure with CIF (Cooling Intensity Factor: -73 mW/cm2). | Device: zeltiq<br>* Zeltiq prototype device (Zeltiq Aesthetics, Pleasanton, CA) approved by FDA 2010<br>|
| Sham Comparator: radiofrequency on right thigh<br>The radio frequency method was applied on right thigh (control side) as sham procedure for 30 minutes through 3000 Hz- amplitude modulated frequency at once. | Device: placebo<br>* radiofrequency with 3000 Hz<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of girths in both thighs | Comparison of circumferences of both thighs | 4 weeks | 
| The change of fat amounts in both thighs | Comparison of cross-sectional areas in both thighs | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of girths in both thighs | Comparison of circumferences of both thighs | 12 weeks | 
| The change of fat amounts in both thighs | Comparison of cross-sectional areas in both thighs | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fat, cryolipolysis, Women, femoral fat