NCT01177787

Clinical Efficacy of Cryolipolysis on the Fat of Thigh in Korean Women

Completed NA Results posted Last updated 14 May 2021

What this trial tests

NA trial testing zeltiq in Lipolysis in 28 participants. Completed in 30 October 2010.

Timeline

1 July 2010

Primary endpoint
30 September 2010

30 October 2010

Quick facts

Lead sponsor	Wonik Trade Company, Korea
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	1 July 2010
Primary completion	30 September 2010
Estimated completion	30 October 2010
Sites	1 location across South Korea

Drugs / interventions tested

• zeltiq
• electrical stimulation

Conditions studied

• Lipolysis — all drugs for Lipolysis →
• Cryotherapy Effect — all drugs for Cryotherapy Effect →

Sponsor

Wonik Trade Company, Korea

Who can join

Adults 20 to 50, female only, with Lipolysis or Cryotherapy Effect. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Cross Sectional Area of Fat in Both Thighs Primary · 4 weeks

reduction of fat amounts on both thighs measured by computerizing tomography

Group	Value	95% CI
Cross Sectional Area on Left Thigh	-420.25	± 3099.55
Cross Sectional Area on Right Thigh	-28.53	± 3526.21

Change of the Girths in Both Thighs Primary · 4 weeks

Mean differences of the circumferences of both thighs measured by inches

Group	Value	95% CI
Zeltiq on Left	0.043	± 0.0362
Electrical Stimulation on Right Side Thigh	-0.15	± 0.1558

Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks Secondary · baseline and 12 weeks

The mean differences of the Cross-Sectional Areas of both Thighs between Baseline and 12 weeks

Group	Value	95% CI
The Change of Fat on Left Thigh Between Baseline and 12 Weeks	1597.8853	± 155.7977453
The Change of Fat Right Thigh Between Baseline and 12 Weeks	1970.0147	± 398.15115

Change of Girths in Both Thighs for 12 Weeks Secondary · 12 weeks

Comparison of circumferences of both thighs for 12 weeks

Group	Value	95% CI
Zeltiq	-0.45	± 0.17
Electrical Stimulation	-0.15	± 0.29

Weight Change for 12 Weeks Secondary · baseline and 12 weeks

Change in weight for 12 weeks

Group	Value	95% CI
Zeltiq	-0.38	± 0.81
Electrical Stimulation	-0.38	± 0.81

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Zeltiq

Serious: 0/14 (0%)

Deaths: 0/14

Electrical Stimulation

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (3 terms — click to expand)

Reaction	System	Zeltiq	Electrical Stimulation
Minor Dermatologic complaint	Skin and subcutaneous tissue disorders	—	—
Minor dermatological compliaint	Skin and subcutaneous tissue disorders	—	—
Minor generalized complaints	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT01177787 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.