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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Wonik Trade Company, Korea.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Wonik Trade Company, Korea
ClinicalTrials.gov Identifier:
NCT01177787
First received: July 28, 2010
Last updated: August 5, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention Phase
Lipolysis
 Device: zeltiq
Device: electrical stimulation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Local Fat Reduction on the Thigh of Korean Women Through Cryolipolysis

Further study details as provided by Wonik Trade Company, Korea:

Primary Outcome Measures:
  • clinical efficacy of fat reduction on thigh by femoral CT [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • clinical efficacy/safety of fat reduction through cryolipolysis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 15
Study Start Date: July 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177787

Locations
Korea, Republic of
Gachon University of Medicine and Science
Incheon, Kyunggi, Korea, Republic of, 405-760
Bariatric clinic/Family medicine, Hong-Ik General Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Wonik Trade Company, Korea
Investigators
Principal Investigator: Kyu Rae Lee, MD.PhD. Director of Bariatric medicine, Family Medicine, Hong-Ik General Hospital
  More Information

Additional Information:
company web site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Chan Hee Kim, Wonik Corporation
ClinicalTrials.gov Identifier: NCT01177787     History of Changes
Other Study ID Numbers: Wonik201007
Study First Received: July 28, 2010
Last Updated: August 5, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013