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

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

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.

Study Overview

• Status: Completed
• Conditions: Cryotherapy Effect; Lipolysis
• Intervention / Treatment: Device: zeltiq; Device: electrical stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Bariatric clinic/Family medicine, Hong-Ik General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wonik Trade Company, Korea
• Investigators: Principal Investigator: Kyu Rae Lee, MD.PhD., Director of Bariatric medicine, Family Medicine, Hong-Ik General Hospital

Publications and helpful links

General Publications

• KR Lee. Clinical Efficacy of Fat Reduction on the Thigh of Korean Women through CryolipolysisJ Obes Weight Loss Ther 2013, 3:6

Helpful Links

• obesity & weight loss therapy web site

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2010
• Primary Completion (ACTUAL): September 30, 2010
• Study Completion (ACTUAL): October 30, 2010

Study Registration Dates

• First Submitted: July 28, 2010
• First Submitted That Met QC Criteria: August 5, 2010
• First Posted (ESTIMATE): August 9, 2010

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: fat; thigh; cryolipolysis; Korean women
• Other Study ID Numbers: Wonik201007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Individual Participant Data Set

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes