Cryotherapy Effect, Lipolysis
Conditions
Keywords
cryolipolysis, fat, thigh, Korean women
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.
Interventions
DEVICEzeltiq
Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.
DEVICEelectrical stimulation
Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
Sponsors
Wonik Trade Company, Korea
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cross Sectional Area of Fat in Both Thighs | 4 weeks | reduction of fat amounts on both thighs measured by computerizing tomography |
| Change of the Girths in Both Thighs | 4 weeks | Mean differences of the circumferences of both thighs measured by inches |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change of Girths in Both Thighs for 12 Weeks | 12 weeks | Comparison of circumferences of both thighs for 12 weeks |
| Weight Change for 12 Weeks | baseline and 12 weeks | Change in weight for 12 weeks |
Countries
South Korea
Participant flow
Pre-assignment details
Two arm, but same group. Electrical Stimulation on Rt thigh versus Zeltiq Application on Left thigh.
Participants by arm
| Arm | Count |
|---|---|
| Zeltiq on Left/Electrical Stimulation on Rt 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Cryolipolysis on Thigh | Lack of Efficacy | 9 |
| Cryolipolysis on Thigh | Lost to Follow-up | 1 |
| Cryolipolysis on Thigh | Protocol Violation | 4 |
Baseline characteristics
| Characteristic | Zeltiq on Left/Electrical Stimulation on Rt |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 28.57 years STANDARD_DEVIATION 7.81 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment South Korea | 14 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 4 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Change in Cross Sectional Area of Fat in Both Thighs
reduction of fat amounts on both thighs measured by computerizing tomography
Time frame: 4 weeks
Population: Cross sectional areas of both thighs at initial visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cross Sectional Area on Left Thigh | Change in Cross Sectional Area of Fat in Both Thighs | -420.25 millimeters squares | Standard Deviation 3099.55 |
| Cross Sectional Area on Right Thigh | Change in Cross Sectional Area of Fat in Both Thighs | -28.53 millimeters squares | Standard Deviation 3526.21 |
Primary
Change of the Girths in Both Thighs
Mean differences of the circumferences of both thighs measured by inches
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cross Sectional Area on Left Thigh | Change of the Girths in Both Thighs | 0.043 inches | Standard Deviation 0.0362 |
| Cross Sectional Area on Right Thigh | Change of the Girths in Both Thighs | -0.15 inches | Standard Deviation 0.1558 |
p-value: 0.503Wilcoxon (Mann-Whitney)
Secondary
Change of Girths in Both Thighs for 12 Weeks
Comparison of circumferences of both thighs for 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cross Sectional Area on Left Thigh | Change of Girths in Both Thighs for 12 Weeks | -0.45 inch | Standard Deviation 0.17 |
| Cross Sectional Area on Right Thigh | Change of Girths in Both Thighs for 12 Weeks | -0.15 inch | Standard Deviation 0.29 |
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
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cross Sectional Area on Left Thigh | Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks | 1597.8853 mm^2 | Standard Deviation 155.7977453 |
| Cross Sectional Area on Right Thigh | Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks | 1970.0147 mm^2 | Standard Deviation 398.15115 |
Secondary
Weight Change for 12 Weeks
Change in weight for 12 weeks
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cross Sectional Area on Left Thigh | Weight Change for 12 Weeks | -0.38 Kg | Standard Deviation 0.81 |
| Cross Sectional Area on Right Thigh | Weight Change for 12 Weeks | -0.38 Kg | Standard Deviation 0.81 |