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

Wonik Trade Company

Status: Completed

Conditions: Lipolysis; Cryotherapy Effect

Treatments: Device: electrical stimulation; Device: zeltiq

Study type: Interventional

Funder types: Industry

Identifiers

NCT01177787

Wonik201007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

zeltiq

Active Comparator group

Description:

Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.

Treatment:

Device: zeltiq

electrical stimulation

Sham Comparator group

Description:

Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency.

Treatment:

Device: electrical stimulation