Effects on Cellulite Appearance

NCT04876118 | Completed Results FDA Device

• 1 other identifier: ZA20-002
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 6

Brief Summary

Evaluate the safety and feasibility effecting the appearance of cellulite on the thigh using CoolSculpting.

Conditions

Body Fat Disorder

Outcome Measures

Primary Outcomes (1)

• Percentage of Photographs Correctly Identified by Blinded Reviewers From the Independent Physician Reviewer Panel

  Photographs of the treatment area taken at baseline and 12-weeks after final treatment were assessed for visual changes. Reported here is the mean percentage (%) of correct baseline identification of images by the blinded independent reviewers.

  Week 12 post final treatment (up to 24 weeks after first treatment)

Secondary Outcomes (1)

• Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)

  Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)

Study Arms (1)

Fat Reduction

EXPERIMENTAL

The treatments are designed to see if the appearance of cellulite can be reduced on the outer thigh.

Device: The ZELTIQ System

Interventions

The ZELTIQ System DEVICE

The CoolSculpting machine will be used to perform the treatments.

Fat Reduction

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects \> 22 years of age and \< 65 years of age.
• Subject has clearly visible cellulite on the intended treatment area (thighs), which in the Investigator's opinion, may benefit from the treatment.
• Subject has not had weight change exceeding 5% in the preceding month.
• Subject agrees to maintain her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
• Subject has read and signed a written informed consent form.

You may not qualify if:

• Subject has had a surgical procedure(s) in the area of intended treatment.
• Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
• Subject has had a non-invasive fat reduction, body contouring, cellulite reduction and/or skin tightening procedure in the area of intended treatment within the past 4 months.
• Presence of significant suntan in the thighs.
• Inability to avoid sun exposure in the thighs.
• Subject has a history of hernia in or adjacent to the areas to be treated.
• Subject needs to administer or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
• Subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
• Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
• Subject has a history of bleeding disorder or is taking any medication that in the Investigator's opinion may increase the subject's risk of bruising.
• Subject has known sensitivity or allergy to isopropyl alcohol and propylene glycol.
• Subject is taking or has taken diet pills or supplements within the past month.
• Subject has an active implanted device such as a pacemaker, defibrillator, implants (e.g. buttock implants), or drug delivery system.
• Subject is pregnant or intending to become pregnant during the study period (in the next 9 months).
• Subject is lactating or has been lactating in the past 6 months.

Sponsors & Collaborators

• Zeltiq Aesthetics: lead

Study Sites (6)

Investigate MD

Scottsdale, Arizona, 85255, United States

Location

Rebecca Fitzgerald, MD Dermatology

Los Angeles, California, 90004, United States

Location

Sasaki Advanced Aesthetics Medical Center

Pasadena, California, 91105, United States

Location

Innovation Research Center

Pleasanton, California, 94588, United States

Location

Laser and Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

Aesthetic Solutions, P.A.

Chapel Hill, North Carolina, 27517, United States

Location

Results Point of Contact

• Title: Sally Hallas, RN, Director Clinical Development - Body Contouring
• Organization: Zeltiq Aesthetics

sally.hallas@abbvie.com

209-294-5571

Study Officials

• Study Director

  Zeltiq Aesthetics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: November 13, 2020
• Primary Completion: October 31, 2022
• Study Completion: November 2, 2022
• Last Updated: March 10, 2025
• Results First Posted: March 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)