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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-01

Study Completion Date

2010-10-30

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.

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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.

Conditions

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Lipolysis Cryotherapy Effect

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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zeltiq

Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.

Group Type ACTIVE_COMPARATOR

zeltiq

Intervention Type DEVICE

Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.

electrical stimulation

Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency.

Group Type SHAM_COMPARATOR

electrical stimulation

Intervention Type DEVICE

Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.

Interventions

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zeltiq

Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.

Intervention Type DEVICE

electrical stimulation

Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.

Intervention Type DEVICE

Other Intervention Names

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zeltiq, cryolipolysis electrical frequency

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes