Clinical trial NCT01177787: Clinical Efficacy of Cryolipolysis on the Fat of Thigh in Korean Women
Official title: Clinical Efficacy of Local Fat Reduction on the Thigh of Korean Women Through Cryolipolysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipolysis
Cryotherapy Effect
Keywords: cryolipolysis
fat
thigh
Korean women
Lead sponsor: Wonik Trade Company, Korea
Sponsor class: INDUSTRY
First posted: 2010-08-09
Enrollment: 28
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Cross Sectional Area of Fat in Both Thighs
timeFrame: 4 weeks
measure: Change of the Girths in Both Thighs
timeFrame: 4 weeks
Secondary outcomes:
measure: Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks
timeFrame: baseline and 12 weeks
measure: Change of Girths in Both Thighs for 12 Weeks
timeFrame: 12 weeks
measure: Weight Change for 12 Weeks
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bariatric clinic/Family medicine, Hong-Ik General Hospital
Study officials:
affiliation: Director of Bariatric medicine, Family Medicine, Hong-Ik General Hospital
name: Kyu Rae Lee, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: KR Lee. Clinical Efficacy of Fat Reduction on the Thigh of Korean Women through CryolipolysisJ Obes Weight Loss Ther 2013, 3:6