Cryolipolysis Induced Gluteal Fat Change

Not Applicable

Completed

• Conditions: Body Weight Changes
• Interventions: Device: placebo; Device: zeltiq

• Registration Number: NCT04568187
• Lead Sponsor: Wonik Trade Company, Korea

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-05-01
• Primary Completion: 2010-08-31
• Study Completion: 2010-08-31
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-29
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
radiofrequency on right thigh	placebo	The radio frequency method was applied on right thigh (control side) as sham procedure for 30 minutes through 3000 Hz- amplitude modulated frequency at once.
cryolipolysis machine on Left inner thigh	zeltiq	Zeltiq machine as intervention procedure was carried out on left inner thigh (treated side) for 1 hour through cool sculpting procedure with CIF (Cooling Intensity Factor: -73 mW/cm2).

Primary Outcome Measures

Name	Time	Method
The change of fat amounts in both thighs	4 weeks	Comparison of cross-sectional areas in both thighs
The change of girths in both thighs	4 weeks	Comparison of circumferences of both thighs

Secondary Outcome Measures

Name	Time	Method
The change of girths in both thighs	12 weeks	Comparison of circumferences of both thighs
The change of fat amounts in both thighs	12 weeks	Comparison of cross-sectional areas in both thighs

Trial Locations

Locations (1)

Bariatric clinic/Family medicine, Hong-Ik General Hospital; 🇰🇷 Seoul, Korea, Republic of