Effects on Cellulite Appearance

Completed · Not applicable

Conditions studied: Body Fat Disorder

In brief

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

Key facts

Study ID

NCT04876118

Run by

Zeltiq Aesthetics

People needed

97

Starts

2020-11-13

Expected to finish

2022-11-02

Last updated by the study team

2025-03-10

Who can join

Age: 22 and older, up to 65. Sex: female. Healthy volunteers: accepted.

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 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.

Where it is running

• Investigate MD — Scottsdale, Arizona, United States
• Rebecca Fitzgerald, MD Dermatology — Los Angeles, California, United States
• Sasaki Advanced Aesthetics Medical Center — Pasadena, California, United States
• Innovation Research Center — Pleasanton, California, United States
• Laser and Skin Surgery Center of Northern California — Sacramento, California, United States
• Aesthetic Solutions, P.A. — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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