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

• Sponsor: Wonik Trade Company, Korea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01177787
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Lipolysis; Cryotherapy Effect	Device: zeltiq; Device: electrical stimulation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Efficacy of Local Fat Reduction on the Thigh of Korean Women Through Cryolipolysis
• Actual Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Sep 30, 2010
• Actual Study Completion Date: Oct 30, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: electrical frequency

Outcome Measures

Primary Outcome Measures

1. Change in Cross Sectional Area of Fat in Both Thighs [4 weeks]

   reduction of fat amounts on both thighs measured by computerizing tomography

2. Change of the Girths in Both Thighs [4 weeks]

   Mean differences of the circumferences of both thighs measured by inches

Secondary Outcome Measures

1. Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks [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 [12 weeks]

   Comparison of circumferences of both thighs for 12 weeks

3. Weight Change for 12 Weeks [baseline and 12 weeks]

   Change in weight for 12 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• obesity & weight loss therapy web site

Publications

• KR Lee. Clinical Efficacy of Fat Reduction on the Thigh of Korean Women through CryolipolysisJ Obes Weight Loss Ther 2013, 3:6

• Responsible Party: Wonik Trade Company, Korea
• ClinicalTrials.gov Identifier: NCT01177787
• Other Study ID Numbers: Wonik201007
• First Posted: Aug 9, 2010
• Last Update Posted: May 14, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Wonik Trade Company, Korea: cryolipolysis; fat; thigh; Korean women

Study Results

Participant Flow

Pre-assignment Detail	Two arm, but same group. Electrical Stimulation on Rt thigh versus Zeltiq Application on Left thigh.

Arm/Group Title	Zeltiq on Left/ Electrical Stimulation on Right Thigh
Arm/Group Description	Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine. zeltiq: Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics. Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency. electrical stimulation: Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
Period Title: Clinical Efficacy of Cryolipolysis
STARTED	28
COMPLETED	28
NOT COMPLETED	0
Period Title: Clinical Efficacy of Cryolipolysis
STARTED	28
COMPLETED	14
NOT COMPLETED	14

Baseline Characteristics

Arm/Group Title	Zeltiq on Left/Electrical Stimulation on Rt
Arm/Group Description	Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine. zeltiq: Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics. Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency. electrical stimulation: Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
Overall Participants	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	14 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.57 (7.81)
Sex: Female, Male (Count of Participants)
Female	14 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	14 100%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
South Korea	14 100%

Outcome Measures

1. Primary Outcome

Title	Change in Cross Sectional Area of Fat in Both Thighs
Description	reduction of fat amounts on both thighs measured by computerizing tomography
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Cross sectional areas of both thighs at initial visit

Arm/Group Title	Cross Sectional Area on Left Thigh	Cross Sectional Area on Right Thigh
Arm/Group Description	Cross Sectional Area (mm squares) on Left Thigh by CT	Cross Sectional Area (mm squares) on Rt thigh by CT
Measure Participants	14	14
Mean (Standard Deviation) [millimeters squares]	-420.25 (3099.55)	-28.53 (3526.21)

2. Primary Outcome

Title	Change of the Girths in Both Thighs
Description	Mean differences of the circumferences of both thighs measured by inches
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Zeltiq on Left	Electrical Stimulation on Right Side Thigh
Arm/Group Description	Cryolipolysis using by Zeltiq for 1 hour	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
Measure Participants	14	14
Mean (Standard Deviation) [inches]	0.043 (0.0362)	-0.15 (0.1558)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cross Sectional Area on Left Thigh
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.503
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.669
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.03
	Estimation Comments

3. Secondary Outcome

Title	Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks
Description	The mean differences of the Cross-Sectional Areas of both Thighs between Baseline and 12 weeks
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	The Change of Fat on Left Thigh Between Baseline and 12 Weeks	The Change of Fat Right Thigh Between Baseline and 12 Weeks
Arm/Group Description	Comparison of Cross-Sectional Area on Left Thigh by CT between baseline and 12 weeks	Comparison of Cross-Sectional areas on Right thigh by CT between baseline and 12 weeks
Measure Participants	14	14
Mean (Standard Deviation) [mm^2]	1597.8853 (155.7977453)	1970.0147 (398.15115)

4. Secondary Outcome

Title	Change of Girths in Both Thighs for 12 Weeks
Description	Comparison of circumferences of both thighs for 12 weeks
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Zeltiq	Electrical Stimulation
Arm/Group Description	zeltiq: Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.	electrical stimulation: Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
Measure Participants	14	14
Mean (Standard Deviation) [inch]	-0.45 (0.17)	-0.15 (0.29)

5. Secondary Outcome

Title	Weight Change for 12 Weeks
Description	Change in weight for 12 weeks
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Zeltiq	Electrical Stimulation
Arm/Group Description	zeltiq: Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.	electrical stimulation: Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
Measure Participants	14	14
Mean (Standard Deviation) [Kg]	-0.38 (0.81)	-0.38 (0.81)

Adverse Events

Arm/Group Title	Zeltiq		Electrical Stimulation
Arm/Group Description	Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.		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.
All Cause Mortality
	Zeltiq		Electrical Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Serious Adverse Events
	Zeltiq		Electrical Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Zeltiq		Electrical Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/14 (28.6%)		0/14 (0%)
Gastrointestinal disorders
Minor generalized complaints	1/14 (7.1%)	1	0/14 (0%)	0
Skin and subcutaneous tissue disorders
Minor dermatological compliaint	1/14 (7.1%)	1	0/14 (0%)	0
Minor Dermatologic complaint	2/14 (14.3%)	2	0/14 (0%)	0

Limitations/Caveats

In the beginning, because this study has some drawback for small sample size , and secondly, although the novel treatment process for radio frequency method included more than 6 sessions, it was performed just at once as sham procedure in this study.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.