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OpenTrials
Completed

NCT Number: NCT04568187

Cryolipolysis Induced Gluteal Fat Change

There was no difference in efficacy in removal of local fat on thigh by cryolipolysis through Zeltiq machine.

Cryolipolysis was found to be safe for 12 week clinical trial.

Completed

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Key information

Age range

18 year and older

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

this study is conducted to investigate the clinical efficacy and safety of cryolipolysis on fat removal of thigh through cryolipolysis.

Healthy premenopausal volunteered women had been conducted to assess their anthropometrical, social, and cardio-metabolic, and femoral fat amount by computer tomography, and adverse events at initial, 4 week, 12 week visit.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • pre-menopausal 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 the counter/herbal supplements to regulate weight or fat mass 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 areas (thigh)
  • subjects with any injection into the area of intended treatment (e.g. cortisone) within 6 months

Treatment and study plan

zeltiq

Device

Zeltiq prototype device (Zeltiq Aesthetics, Pleasanton, CA) approved by FDA 2010

PLACEBO

Device

radiofrequency with 3000 Hz

Primary outcomes

  1. The change of girths in both thighs

    Time frame: 4 weeks

    Comparison of circumferences of both thighs

  2. The change of fat amounts in both thighs

    Time frame: 4 weeks

    Comparison of cross-sectional areas in both thighs

Secondary outcomes

  1. The change of girths in both thighs

    Time frame: 12 weeks

    Comparison of circumferences of both thighs

  2. The change of fat amounts in both thighs

    Time frame: 12 weeks

    Comparison of cross-sectional areas in both thighs

Sponsors and collaborators

Lead sponsor

Wonik Trade Company, Korea

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 29, 2020
Registry last updated
Dec 7, 2020

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.

Published trials that share one or more normalized conditions with this study.