Body Weight Changes
Conditions
Keywords
fat, cryolipolysis, Women, femoral fat
Brief summary
There was no difference in efficacy in removal of local fat on thigh by cryolipolysis through Zeltiq machine. Cryolipolysis was found to be safe for 12 week clinical trial.
Detailed description
this study is conducted to investigate the clinical efficacy and safety of cryolipolysis on fat removal of thigh through cryolipolysis. Healthy premenopausal volunteered women had been conducted to assess their anthropometrical, social, and cardio-metabolic, and femoral fat amount by computer tomography, and adverse events at initial, 4 week, 12 week visit.
Interventions
DEVICEzeltiq
Zeltiq prototype device (Zeltiq Aesthetics, Pleasanton, CA) approved by FDA 2010
DEVICEplacebo
radiofrequency with 3000 Hz
Sponsors
Wonik Trade Company, Korea
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
the sequential split-body trials
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* pre-menopausal 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 the counter/herbal supplements to regulate weight or fat mass 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 areas (thigh) * subjects with any injection into the area of intended treatment (e.g. cortisone) within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of girths in both thighs | 4 weeks | Comparison of circumferences of both thighs |
| The change of fat amounts in both thighs | 4 weeks | Comparison of cross-sectional areas in both thighs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of girths in both thighs | 12 weeks | Comparison of circumferences of both thighs |
| The change of fat amounts in both thighs | 12 weeks | Comparison of cross-sectional areas in both thighs |
Countries
South Korea
Outcome results
None listed