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NCT04568187 Clinical Trial

Cryolipolysis Induced Gluteal Fat Change

Body Weight Changes Clinical Trial

Official title:
Clinical Efficacy of Fat Reduction on the Thigh of Korean Women Through Cryolipolysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04568187
Other study ID # 01177787
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2010
Est. completion date August 31, 2010

Study information
Verified date December 2020
Source Wonik Trade Company, Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date August 31, 2010
Est. primary completion date August 31, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - pre-menopausal 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 the counter/herbal supplements to regulate weight or fat mass 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 areas (thigh) - subjects with any injection into the area of intended treatment (e.g. cortisone) within 6 months

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• zeltiq
Zeltiq prototype device (Zeltiq Aesthetics, Pleasanton, CA) approved by FDA 2010
• placebo
radiofrequency with 3000 Hz

Locations
Country Name City State
Korea, Republic of Bariatric clinic/Family medicine, Hong-Ik General Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Wonik Trade Company, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The change of girths in both thighs Comparison of circumferences of both thighs 4 weeks
Primary The change of fat amounts in both thighs Comparison of cross-sectional areas in both thighs 4 weeks
Secondary The change of girths in both thighs Comparison of circumferences of both thighs 12 weeks
Secondary The change of fat amounts in both thighs Comparison of cross-sectional areas in both thighs 12 weeks
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