Cryolipolysis Induced Gluteal Fat Change

Wonik Trade Company, Korea15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Body Weight Changes

Interventions

zeltiqDEVICE

Zeltiq prototype device (Zeltiq Aesthetics, Pleasanton, CA) approved by FDA 2010

placeboDEVICE

radiofrequency with 3000 Hz

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Bariatric clinic/Family medicine, Hong-Ik General Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

The change of girths in both thighs

Comparison of circumferences of both thighs

Time frame: 4 weeks

The change of fat amounts in both thighs

Comparison of cross-sectional areas in both thighs

Time frame: 4 weeks

Secondary Outcomes

The change of girths in both thighs

Comparison of circumferences of both thighs

Time frame: 12 weeks

The change of fat amounts in both thighs

Comparison of cross-sectional areas in both thighs

Time frame: 12 weeks

Data from ClinicalTrials.gov

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