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Completed

NCT Number: NCT01177787

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

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.

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Key information

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bariatric clinic/Family medicine, Hong-Ik General Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zeltiq

Device

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

Other names: zeltiq, cryolipolysis

Electrical Stimulation

Device

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

Other names: electrical frequency

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Wonik Trade Company, Korea

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 9, 2010
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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