Clinical Trials Directory

Trials / Completed

CompletedNCT01177787

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

Clinical Efficacy of Local Fat Reduction on the Thigh of Korean Women Through Cryolipolysis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
28 (actual)
Sponsor
Wonik Trade Company, Korea · Industry
Sex
Female
Age
20 Years – 50 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICEzeltiqCryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.
DEVICEelectrical stimulationLipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.

Timeline

Start date
2010-07-01
Primary completion
2010-09-30
Completion
2010-10-30
First posted
2010-08-09
Last updated
2021-05-14
Results posted
2021-05-14

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01177787. Inclusion in this directory is not an endorsement.