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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01177787
Other study ID # Wonik201007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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