Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2010-05-01
2010-08-31
Brief Summary
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Cryolipolysis was found to be safe for 12 week clinical trial.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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cryolipolysis machine on Left inner thigh
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).
zeltiq
Zeltiq prototype device (Zeltiq Aesthetics, Pleasanton, CA) approved by FDA 2010
radiofrequency on right thigh
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.
placebo
radiofrequency with 3000 Hz
Interventions
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zeltiq
Zeltiq prototype device (Zeltiq Aesthetics, Pleasanton, CA) approved by FDA 2010
placebo
radiofrequency with 3000 Hz
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
Yes
Sponsors
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Wonik Trade Company, Korea
INDUSTRY
Responsible Party
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Principal Investigators
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Kyu R Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hongik General Hospital
Locations
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Bariatric clinic/Family medicine, Hong-Ik General Hospital
Seoul, , South Korea
Countries
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Related Links
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clinical efficacy of fat reduction on the thigh of Korean women through cryolipolysis
Other Identifiers
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01177787
Identifier Type: -
Identifier Source: org_study_id