Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cryolipolysis machine on Left inner thigh | Active Comparator | Zeltiq machine as intervention procedure was carried out on left inner thigh (treated side) for 1 hour through cool sculpting procedure with CIF (Cooling Intensity Factor: -73 mW/cm2). |
|
| radiofrequency on right thigh | Sham Comparator | The radio frequency method was applied on right thigh (control side) as sham procedure for 30 minutes through 3000 Hz- amplitude modulated frequency at once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zeltiq | Device | Zeltiq prototype device (Zeltiq Aesthetics, Pleasanton, CA) approved by FDA 2010 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of girths in both thighs | Comparison of circumferences of both thighs | 4 weeks |
| The change of fat amounts in both thighs | Comparison of cross-sectional areas in both thighs | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change of girths in both thighs | Comparison of circumferences of both thighs | 12 weeks |
| The change of fat amounts in both thighs | Comparison of cross-sectional areas in both thighs |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Healthy Women
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kyu R Lee, MD, PhD | Hongik General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bariatric clinic/Family medicine, Hong-Ik General Hospital | Seoul | South Korea |
Not provided
| Label | URL |
|---|---|
| clinical efficacy of fat reduction on the thigh of Korean women through cryolipolysis | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| C564245 | Platelet Glycoprotein IV Deficiency |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
the sequential split-body trials
Not provided
Not provided
Not provided
Not provided
| placebo | Device | radiofrequency with 3000 Hz |
|
| 12 weeks |