Clinical trial NCT04876118: Effects on Cellulite Appearance
Official title: Feasibility Study of CoolSculpting Effects on Cellulite Appearance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat Disorder
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2021-05-06
Enrollment: 97
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Photographs Correctly Identified by Blinded Reviewers From the Independent Physician Reviewer Panel
timeFrame: Week 12 post final treatment (up to 24 weeks after first treatment)
Secondary outcomes:
measure: Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
timeFrame: Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Investigate MD
state: Arizona
city: Los Angeles
country: United States
facility: Rebecca Fitzgerald, MD Dermatology
state: California
city: Pasadena
country: United States
facility: Sasaki Advanced Aesthetics Medical Center
state: California
city: Pleasanton
country: United States
facility: Innovation Research Center
state: California
city: Sacramento
country: United States
facility: Laser and Skin Surgery Center of Northern California
state: California
city: Chapel Hill
country: United States
facility: Aesthetic Solutions, P.A.
state: North Carolina
Study officials:
affiliation: Zeltiq Aesthetics
name: Study Director
role: STUDY_DIRECTOR
References: