Cryolipolysis Induced Gluteal Fat Change

Wonik Trade Company

Status: Completed

Conditions: Body Weight Changes

Treatments: Device: zeltiq; Device: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04568187

01177787

Details and patient eligibility

About

There was no difference in efficacy in removal of local fat on thigh by cryolipolysis through Zeltiq machine.

Cryolipolysis was found to be safe for 12 week clinical trial.

Full description

this study is conducted to investigate the clinical efficacy and safety of cryolipolysis on fat removal of thigh through cryolipolysis.

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.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• pre-menopausal 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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

cryolipolysis machine on Left inner thigh

Active Comparator group

Description:

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).

Treatment:

Device: zeltiq

radiofrequency on right thigh

Sham Comparator group

Description:

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.

Treatment:

Device: placebo