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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

Tracking Information
First Submitted Date  ICMJE July 28, 2010
First Posted Date  ICMJE August 9, 2010
Results First Submitted Date  ICMJE August 28, 2020
Results First Posted Date  ICMJE May 14, 2021
Last Update Posted Date May 14, 2021
Actual Study Start Date  ICMJE July 1, 2010
Actual Primary Completion Date September 30, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2021)
  • 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
  • Change of the Girths in Both Thighs [ Time Frame: 4 weeks ]
    Mean differences of the circumferences of both thighs measured by inches
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2010)
clinical efficacy of fat reduction on thigh by femoral CT [ Time Frame: 1 month ]
As the difference of fat amounts on both thigh measured by femoral CT will be evaluated, fat amounts, metabolic variables, gross appearance on ipsilateral thigh by cryolipolysis (Zeltiq) would be compared to those on controlateral thigh by frequency method for 4 weeks.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2021)
  • 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
  • Change of Girths in Both Thighs for 12 Weeks [ Time Frame: 12 weeks ]
    Comparison of circumferences of both thighs for 12 weeks
  • Weight Change for 12 Weeks [ Time Frame: baseline and 12 weeks ]
    Change in weight for 12 weeks
Original Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2010)
clinical efficacy/safety of fat reduction through cryolipolysis [ Time Frame: 3 months ]
Histological examination under skin biopsy, and gross appearance, and metabolic variables, and fat amounts by femoral CT, and questionnaire for satisfaction will be compared for past 3 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Efficacy of Cryolipolysis on the Fat of Thigh in Korean Women
Official Title  ICMJE Clinical Efficacy of Local Fat Reduction on the Thigh of Korean Women Through Cryolipolysis
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lipolysis
  • Cryotherapy Effect
Intervention  ICMJE
  • 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
  • Device: electrical stimulation
    Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
    Other Name: electrical frequency
Study Arms  ICMJE
  • Active Comparator: zeltiq
    Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.
    Intervention: Device: zeltiq
  • Sham Comparator: electrical stimulation
    Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency.
    Intervention: Device: electrical stimulation
Publications * KR Lee. Clinical Efficacy of Fat Reduction on the Thigh of Korean Women through CryolipolysisJ Obes Weight Loss Ther 2013, 3:6

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2021)
28
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2010)
15
Actual Study Completion Date  ICMJE October 30, 2010
Actual Primary Completion Date September 30, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01177787
Other Study ID Numbers  ICMJE Wonik201007
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wonik Trade Company, Korea
Study Sponsor  ICMJE Wonik Trade Company, Korea
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyu Rae Lee, MD.PhD. Director of Bariatric medicine, Family Medicine, Hong-Ik General Hospital
PRS Account Wonik Trade Company, Korea
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP