Overview

This trial is active, not recruiting.

Condition lipolysis
Treatments zeltiq, electrical stimulation
Phase phase 1/phase 2
Sponsor Wonik Trade Company, Korea
Start date July 2010
End date August 2010
Trial size 15 participants
Trial identifier NCT01177787, Wonik201007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.
zeltiq zeltiq, cryolipolysis
Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.
(Sham Comparator)
Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency.
electrical stimulation electrical frequency
Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.

Primary Outcomes

Measure
clinical efficacy of fat reduction on thigh by femoral CT
time frame: 1 month

Secondary Outcomes

Measure
clinical efficacy/safety of fat reduction through cryolipolysis
time frame: 3 months

Eligibility Criteria

Female participants from 20 years up to 50 years old.

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

Additional Information

Official title Clinical Efficacy of Local Fat Reduction on the Thigh of Korean Women Through Cryolipolysis
Principal investigator Kyu Rae Lee, MD.PhD.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by Wonik Trade Company, Korea.