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

Cryotherapy Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177787
• Other study ID #: Wonik201007
• Status: Completed
• Phase: N/A
• Start date: July 1, 2010
• Est. completion date: October 30, 2010

Study information

• Verified date: April 2021
• Source: Wonik Trade Company, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 30, 2010
• Est. primary completion date: September 30, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cryotherapy Effect
• Lipolysis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Bariatric clinic/Family medicine, Hong-Ik General Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Wonik Trade Company, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cross Sectional Area of Fat in Both Thighs	reduction of fat amounts on both thighs measured by computerizing tomography	4 weeks
Primary	Change of the Girths in Both Thighs	Mean differences of the circumferences of both thighs measured by inches	4 weeks
Secondary	Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks	The mean differences of the Cross-Sectional Areas of both Thighs between Baseline and 12 weeks	baseline and 12 weeks
Secondary	Change of Girths in Both Thighs for 12 Weeks	Comparison of circumferences of both thighs for 12 weeks	12 weeks
Secondary	Weight Change for 12 Weeks	Change in weight for 12 weeks	baseline and 12 weeks

External Links

•   obesity & weight loss therapy web site