N/A N=28 Treatment

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

Lipolysis · Cryotherapy Effect

Bottom Line

View on ClinicalTrials.gov: NCT01177787 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2021

Primary outcome: Primary: Change in Cross Sectional Area of Fat in Both Thighs — -420.25; -28.53 millimeters squares

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: zeltiq (Device); electrical stimulation (Device)
Age: Adult · 20+ yrs
Sex: Female
Sponsor: Wonik Trade Company, Korea
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Cross Sectional Area of Fat in Both Thighs	-420.25; -28.53	—
PRIMARY Change of the Girths in Both Thighs	0.043; -0.15	0.503
SECONDARY Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks	1597.8853; 1970.0147	—
SECONDARY Change of Girths in Both Thighs for 12 Weeks	-0.45; -0.15	—
SECONDARY Weight Change for 12 Weeks	-0.38; -0.38	—

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.

Eligibility Criteria

Inclusion Criteria

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

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01177787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.