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Cryolipolysis Induced Gluteal Fat Change

Primary Purpose

Body Weight Changes

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
zeltiq
placebo
Sponsored by
Wonik Trade Company, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Weight Changes focused on measuring fat, cryolipolysis, Women, femoral fat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Bariatric clinic/Family medicine, Hong-Ik General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

cryolipolysis machine on Left inner thigh

radiofrequency on right thigh

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

The change of girths in both thighs
Comparison of circumferences of both thighs
The change of fat amounts in both thighs
Comparison of cross-sectional areas in both thighs

Secondary Outcome Measures

The change of girths in both thighs
Comparison of circumferences of both thighs
The change of fat amounts in both thighs
Comparison of cross-sectional areas in both thighs

Full Information

First Posted
May 19, 2020
Last Updated
December 3, 2020
Sponsor
Wonik Trade Company, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT04568187
Brief Title
Cryolipolysis Induced Gluteal Fat Change
Official Title
Clinical Efficacy of Fat Reduction on the Thigh of Korean Women Through Cryolipolysis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2010 (Actual)
Primary Completion Date
August 31, 2010 (Actual)
Study Completion Date
August 31, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wonik Trade Company, Korea

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes
Keywords
fat, cryolipolysis, Women, femoral fat

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
the sequential split-body trials
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cryolipolysis machine on Left inner thigh
Arm Type
Active Comparator
Arm Description
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).
Arm Title
radiofrequency on right thigh
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
zeltiq
Intervention Description
Zeltiq prototype device (Zeltiq Aesthetics, Pleasanton, CA) approved by FDA 2010
Intervention Type
Device
Intervention Name(s)
placebo
Intervention Description
radiofrequency with 3000 Hz
Primary Outcome Measure Information:
Title
The change of girths in both thighs
Description
Comparison of circumferences of both thighs
Time Frame
4 weeks
Title
The change of fat amounts in both thighs
Description
Comparison of cross-sectional areas in both thighs
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The change of girths in both thighs
Description
Comparison of circumferences of both thighs
Time Frame
12 weeks
Title
The change of fat amounts in both thighs
Description
Comparison of cross-sectional areas in both thighs
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Healthy Women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu R Lee, MD, PhD
Organizational Affiliation
Hongik General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bariatric clinic/Family medicine, Hong-Ik General Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
http://dx.doi.org/10.4172/2165-7904.1000203
Description
clinical efficacy of fat reduction on the thigh of Korean women through cryolipolysis

Learn more about this trial

Cryolipolysis Induced Gluteal Fat Change

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