Cryolipolysis Induced Gluteal Fat Change

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

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.

Study Overview

• Status: Completed
• Conditions: Body Weight Changes
• Intervention / Treatment: Device: zeltiq; Device: placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Bariatric clinic/Family medicine, Hong-Ik General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: cryolipolysis machine on Left inner thigh; Zeltiq machine as intervention procedure was carried out on left inner thigh (treated side) for 1 hour through cool sculpting procedure with CIF (Cooling Intensity Factor: -73 mW/cm2).	Device: zeltiq; Zeltiq prototype device (Zeltiq Aesthetics, Pleasanton, CA) approved by FDA 2010
SHAM_COMPARATOR: radiofrequency on right thigh; The radio frequency method was applied on right thigh (control side) as sham procedure for 30 minutes through 3000 Hz- amplitude modulated frequency at once.	Device: placebo; radiofrequency with 3000 Hz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of girths in both thighs	Comparison of circumferences of both thighs	4 weeks
The change of fat amounts in both thighs	Comparison of cross-sectional areas in both thighs	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of girths in both thighs	Comparison of circumferences of both thighs	12 weeks
The change of fat amounts in both thighs	Comparison of cross-sectional areas in both thighs	12 weeks

Collaborators and Investigators

• Sponsor: Wonik Trade Company, Korea
• Investigators: Principal Investigator: Kyu R Lee, MD, PhD, Hongik General Hospital

Publications and helpful links

Helpful Links

• clinical efficacy of fat reduction on the thigh of Korean women through cryolipolysis

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2010
• Primary Completion (ACTUAL): August 31, 2010
• Study Completion (ACTUAL): August 31, 2010

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (ACTUAL): September 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Women; fat; cryolipolysis; femoral fat
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes
• Other Study ID Numbers: 01177787

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes