NCT01177787

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 9, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2010

Completed
10.5 years until next milestone

Results Posted

Study results publicly available

May 14, 2021

Completed
Last Updated

May 14, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

July 28, 2010

Results QC Date

August 28, 2020

Last Update Submit

April 23, 2021

Conditions

LipolysisCryotherapy Effect

Keywords

cryolipolysisfatthighKorean women

Outcome Measures

Primary Outcomes (2)

  • Change in Cross Sectional Area of Fat in Both Thighs

    reduction of fat amounts on both thighs measured by computerizing tomography

    4 weeks

  • Change of the Girths in Both Thighs

    Mean differences of the circumferences of both thighs measured by inches

    4 weeks

Secondary Outcomes (3)

  • Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks

    baseline and 12 weeks

  • Change of Girths in Both Thighs for 12 Weeks

    12 weeks

  • Weight Change for 12 Weeks

    baseline and 12 weeks

Study Arms (2)

zeltiq

ACTIVE COMPARATOR

Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine.

Device: zeltiq

electrical stimulation

SHAM COMPARATOR

Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency.

Device: electrical stimulation

Interventions

zeltiqDEVICE

Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.

Also known as: zeltiq, cryolipolysis
zeltiq
electrical stimulationDEVICE

Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.

Also known as: electrical frequency
electrical stimulation

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • premenopausal healthy women
  • subjects with body mass index \>= 18.
  • subjects with visible fat on both thigh
  • subjects to understand and agree to this study protocol

You may not qualify if:

  • 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 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 area (thigh)
  • subjects with any injection into the area of intended treatment (e.g. cortisone) within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bariatric clinic/Family medicine, Hong-Ik General Hospital

Seoul, South Korea

Location

Related Publications (1)

  • KR Lee. Clinical Efficacy of Fat Reduction on the Thigh of Korean Women through CryolipolysisJ Obes Weight Loss Ther 2013, 3:6

    BACKGROUND

Related Links

MeSH Terms

Conditions

Platelet Glycoprotein IV Deficiency

Interventions

Electric Stimulation

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Limitations and Caveats

In the beginning, because this study has some drawback for small sample size , and secondly, although the novel treatment process for radio frequency method included more than 6 sessions, it was performed just at once as sham procedure in this study.

Results Point of Contact

Title
Dr. Kyu Rae LeeMD.PhD.
Organization
Gachon University of Medicine and Science
baria07@daum.net
8232-770-1215

Study Officials

  • Kyu Rae Lee, MD.PhD.

    Director of Bariatric medicine, Family Medicine, Hong-Ik General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2010

First Posted

August 9, 2010

Study Start

July 1, 2010

Primary Completion

September 30, 2010

Study Completion

October 30, 2010

Last Updated

May 14, 2021

Results First Posted

May 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Individual Participant Data Set Access

Locations

KR(1)