LipolysisNCT01177787
Clinical Efficacy of Cryolipolysis on the Fat of Thigh in Korean Women
A study testing zeltiq and electrical stimulation in people with Lipolysis and Cryotherapy Effect, run by Wonik Trade Company, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipolysis, Cryotherapy Effect
- What is being tested?
- zeltiq and electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2010to 30 Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Bariatric clinic/Family medicine, Hong-Ik General Hospital
Seoul
About this study
Official title: Clinical Efficacy of Local Fat Reduction on the Thigh of Korean Women Through Cryolipolysis
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.
Read the detailed description
Cryolipolysis is a new concept to reduce fat since Zeltiq machine had been introduced several years ago. Several different trials such as high frequency, liposuction and chemical lipolysis to remove fat had been emerged and tried. Therefore, we would like to know the clinical efficacy of cryolipolysis through comparative experiment with former frequency method on each thigh on healthy Korean women.
Healthy premenopausal women who want to reduce the fat on thigh were included. 28 healthy volunteered women recruited for this study, 15 subjects among participated after interviewing, sampling their metabolic variables at initial visit. A total of 15 subjects would be investigated through food diary(24hour), femoral CT, anthropometric, metabolic variables at initial, 4th, 12th week. Histological examination under skin(initial and 12th week), questionnaire(4th, 12th week) for satisfaction, adverse events would be monitored during 3 month.
- Conditions
- Lipolysis, Cryotherapy Effect
- Being tested
- zeltiq, electrical stimulation
- Keywords
- cryolipolysis, fat, thigh, Korean women
- Medical subject headings
- Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zeltiqDevice
Also called zeltiq, cryolipolysis
Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.
electrical stimulationDevice
Also called electrical frequency
Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
| Study group | Role | What they receive |
|---|---|---|
| zeltiq | Active comparator | Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine. Receives: Device: zeltiq |
| electrical stimulation | Sham comparator | Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency. Receives: Device: electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cross Sectional Area of Fat in Both Thighs
reduction of fat amounts on both thighs measured by computerizing tomography
Measured: 4 weeks
Change of the Girths in Both Thighs
Mean differences of the circumferences of both thighs measured by inches
Measured: 4 weeks
Secondary outcomes (3)
Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks
The mean differences of the Cross-Sectional Areas of both Thighs between Baseline and 12 weeks
Measured: baseline and 12 weeks
Change of Girths in Both Thighs for 12 Weeks
Comparison of circumferences of both thighs for 12 weeks
Measured: 12 weeks
Weight Change for 12 Weeks
Change in weight for 12 weeks
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study start1 Jul 2010
- Primary completion30 Sep 2010
- Study completion30 Oct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LipolysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonik Trade Company, Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyu Rae Lee, MD.PhD., Principal investigator, Director of Bariatric medicine, Family Medicine, Hong-Ik General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177787
- Sponsor's protocol ID
- Wonik201007
- Status last verified
- Apr 2021
- First submitted
- 28 Jul 2010
- Last updated
- 14 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
KR Lee. Clinical Efficacy of Fat Reduction on the Thigh of Korean Women through CryolipolysisJ Obes Weight Loss Ther 2013, 3:6
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Local Fat Reduction on the Thigh of Korean Women Through Cryolipolysis
- ClinicalTrials.gov ID
- NCT01177787
- Acronym / sponsor ID
- Wonik201007
- Conditions
- Lipolysis, Cryotherapy Effect
- Keywords
- cryolipolysis, fat, thigh, Korean women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Wonik Trade Company, KoreaIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2010 (actual)
- Primary completion
- 30 Sep 2010 (actual)
- Study completion
- 30 Oct 2010 (actual)
- First posted
- 9 Aug 2010 (estimated)
- Results
- Posted 14 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cryolipolysis is a new concept to reduce fat since Zeltiq machine had been introduced several years ago. Several different trials such as high frequency, liposuction and chemical lipolysis to remove fat had been emerged and tried. Therefore, we would like to know the clinical efficacy of cryolipolysis through comparative experiment with former frequency method on each thigh on healthy Korean women.
Healthy premenopausal women who want to reduce the fat on thigh were included. 28 healthy volunteered women recruited for this study, 15 subjects among participated after interviewing, sampling their metabolic variables at initial visit. A total of 15 subjects would be investigated through food diary(24hour), femoral CT, anthropometric, metabolic variables at initial, 4th, 12th week. Histological examination under skin(initial and 12th week), questionnaire(4th, 12th week) for satisfaction, adverse events would be monitored during 3 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zeltiq | Active comparator | Device: zeltiqCryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine. |
| electrical stimulation | Sham comparator | Device: electrical stimulationLipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zeltiqAlso: zeltiq, cryolipolysisCryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics. | Device | zeltiq |
| electrical stimulationAlso: electrical frequencyLipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency. | Device | electrical stimulation |
Primary outcome
Change in Cross Sectional Area of Fat in Both Thighs
Time frame: 4 weeks
reduction of fat amounts on both thighs measured by computerizing tomography
Change of the Girths in Both Thighs
Time frame: 4 weeks
Mean differences of the circumferences of both thighs measured by inches
3 secondary outcomes
Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks
Time frame: baseline and 12 weeks
Change of Girths in Both Thighs for 12 Weeks
Time frame: 12 weeks
Weight Change for 12 Weeks
Time frame: baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundKR Lee. Clinical Efficacy of Fat Reduction on the Thigh of Korean Women through CryolipolysisJ Obes Weight Loss Ther 2013, 3:6
- obesity \& weight loss therapy web siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu Rae Lee, MD.PhD. principal investigator
Director of Bariatric medicine, Family Medicine, Hong-Ik General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zeltiq and electrical stimulation in people with Lipolysis and Cryotherapy Effect, run by Wonik Trade Company, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cross Sectional Area of Fat in Both Thighs (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01177787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.