Effects on Cellulite Appearance (EFC)

Feasibility Study of CoolSculpting Effects on Cellulite Appearance

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

Study Overview

• Status: Recruiting
• Conditions: Body Fat Disorder
• Intervention / Treatment: Device: The ZELTIQ System

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tonia N Madere; Phone Number: 925-474-2537; Email: tonia.madere@allergan.com

Study Locations

• United States
  • California
    • Pleasanton, California, United States, 94588
      • Recruiting
      • Innovation Research Center
      • Contact: Alison Akbari; Phone Number: 925-474-2501; Email: clinicalstudy@pleasantonirc.com
      • Contact: Theresita Gray, RN; Phone Number: 925-474-2501; Email: clinicalstudy@pleasantonirc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites, that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
• 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.
• Subject is unable or unwilling to comply with the study requirements.
• Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
• Any other condition or laboratory value that would, in the professional opinion of the Investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fat Reduction; The treatments are designed to see if the appearance of cellulite can be reduced on the outer thigh with a new applicator design.	Device: The ZELTIQ System; The CoolSculpting machine will be used to perform the treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visible changes in the treated areas on Photos	Comparison of baseline and 12-week post-final treatment photographs to assess visible changes in the treated areas.	one-month post final data collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE's	The frequency of device and procedure-related adverse events (AEs), including device-related serious adverse events (SADEs), will be summarized. Safety Endpoint:	one-month post final data collection

Collaborators and Investigators

• Sponsor: Zeltiq Aesthetics
• Investigators: Study Director: Lori Brandt, BSN, Zeltiq Aesthetics

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2020
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Cellulite
• Other Study ID Numbers: ZA20-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No