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

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ClinicalTrials.gov Identifier: NCT01177787
Recruitment Status : Completed
First Posted : August 9, 2010
Results First Posted : May 14, 2021
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Wonik Trade Company, Korea

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lipolysis Cryotherapy Effect Device: zeltiq Device: electrical stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Local Fat Reduction on the Thigh of Korean Women Through Cryolipolysis
Actual Study Start Date : July 1, 2010
Actual Primary Completion Date : September 30, 2010
Actual Study Completion Date : October 30, 2010

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 Name: 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 Name: electrical frequency




Primary Outcome Measures :
  1. Change in Cross Sectional Area of Fat in Both Thighs [ Time Frame: 4 weeks ]
    reduction of fat amounts on both thighs measured by computerizing tomography

  2. Change of the Girths in Both Thighs [ Time Frame: 4 weeks ]
    Mean differences of the circumferences of both thighs measured by inches


Secondary Outcome Measures :
  1. Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks [ Time Frame: baseline and 12 weeks ]
    The mean differences of the Cross-Sectional Areas of both Thighs between Baseline and 12 weeks

  2. Change of Girths in Both Thighs for 12 Weeks [ Time Frame: 12 weeks ]
    Comparison of circumferences of both thighs for 12 weeks

  3. Weight Change for 12 Weeks [ Time Frame: baseline and 12 weeks ]
    Change in weight for 12 weeks



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177787


Locations
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Korea, Republic of
Bariatric clinic/Family medicine, Hong-Ik General Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Wonik Trade Company, Korea
Investigators
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Principal Investigator: Kyu Rae Lee, MD.PhD. Director of Bariatric medicine, Family Medicine, Hong-Ik General Hospital
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

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

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Responsible Party: Wonik Trade Company, Korea
ClinicalTrials.gov Identifier: NCT01177787    
Other Study ID Numbers: Wonik201007
First Posted: August 9, 2010    Key Record Dates
Results First Posted: May 14, 2021
Last Update Posted: May 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Wonik Trade Company, Korea:
cryolipolysis
fat
thigh
Korean women