Clinical Efficacy of Cryolipolysis on the Fat of Thigh in Korean Women

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.

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.

• Device: zeltiq
  Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.
  Other Name: zeltiq, cryolipolysis
• Device: electrical stimulation
  Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
  Other Name: electrical frequency

• Active Comparator: zeltiq
  Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.
  Intervention: Device: zeltiq
• Sham Comparator: electrical stimulation
  Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency.
  Intervention: Device: electrical stimulation

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