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

Wonik Trade Company, Korea28 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lipolysis Cryotherapy Effect

Interventions

zeltiqDEVICE

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

electrical stimulationDEVICE

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Bariatric clinic/Family medicine, Hong-Ik General Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Change in Cross Sectional Area of Fat in Both Thighs

reduction of fat amounts on both thighs measured by computerizing tomography

Time frame: 4 weeks

Change of the Girths in Both Thighs

Mean differences of the circumferences of both thighs measured by inches

Time frame: 4 weeks

Secondary Outcomes

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

Time frame: baseline and 12 weeks

Change of Girths in Both Thighs for 12 Weeks

Comparison of circumferences of both thighs for 12 weeks

Time frame: 12 weeks

Weight Change for 12 Weeks

Change in weight for 12 weeks

Time frame: baseline and 12 weeks

Data from ClinicalTrials.gov

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