Cryolipolysis Induced Gluteal Fat Change

Sponsor

Wonik Trade Company, Korea (Industry)

Overall Status

Completed

CT.gov ID

NCT04568187

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Body Weight Changes	Device: zeltiq Device: placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

the sequential split-body trialsthe sequential split-body trials

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Aug 31, 2010

Actual Study Completion Date :

Aug 31, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: cryolipolysis machine on Left inner thigh 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).	Device: zeltiq Zeltiq prototype device (Zeltiq Aesthetics, Pleasanton, CA) approved by FDA 2010
Sham Comparator: radiofrequency on right thigh 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.	Device: placebo radiofrequency with 3000 Hz

Arm

Intervention/Treatment

Active Comparator: cryolipolysis machine on Left inner thigh

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).

Device: zeltiq

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

Sham Comparator: radiofrequency on right thigh

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.

Device: placebo

radiofrequency with 3000 Hz

Outcome Measures

Primary Outcome Measures

The change of girths in both thighs [4 weeks]
Comparison of circumferences of both thighs
The change of fat amounts in both thighs [4 weeks]
Comparison of cross-sectional areas in both thighs

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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