Cryolipolysis Induced Gluteal Fat Change

NCT04568187 | Completed FDA Device

• 1 other identifier: 01177787
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Body Weight Changes

Keywords

fat; cryolipolysis; Women; femoral fat

Outcome Measures

Primary Outcomes (2)

• The change of girths in both thighs

  Comparison of circumferences of both thighs

  4 weeks

• The change of fat amounts in both thighs

  Comparison of cross-sectional areas in both thighs

  4 weeks

Secondary Outcomes (2)

• The change of girths in both thighs

  12 weeks

• The change of fat amounts in both thighs

  12 weeks

Study Arms (2)

cryolipolysis machine on Left inner thigh

ACTIVE COMPARATOR

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).

Device: zeltiq

radiofrequency on right thigh

SHAM COMPARATOR

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.

Device: placebo

Interventions

zeltiq DEVICE

Zeltiq prototype device (Zeltiq Aesthetics, Pleasanton, CA) approved by FDA 2010

cryolipolysis machine on Left inner thigh

placebo DEVICE

radiofrequency with 3000 Hz

radiofrequency on right thigh

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Healthy Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wonik Trade Company, Korea: lead

Study Sites (1)

Bariatric clinic/Family medicine, Hong-Ik General Hospital

Seoul, South Korea

Location

Related Links

• clinical efficacy of fat reduction on the thigh of Korean women through cryolipolysis

MeSH Terms

Conditions

Body Weight Changes; Platelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyu R Lee, MD, PhD

  Hongik General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: the sequential split-body trials

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: September 29, 2020
• Study Start: May 1, 2010
• Primary Completion: August 31, 2010
• Study Completion: August 31, 2010
• Last Updated: December 7, 2020

Record last verified: 2020-12

Locations

KR (1)