Clinical trial NCT04897867: CoolSculpting® Elite for Non-Invasive Fat Reduction
Official title: CoolSculpting® Elite: Multi-Country Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen, Flanks, Upper Arms, Inner Thighs, Outer Thighs and Submental Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-invasive Fat Reduction
Keywords: Fat Reduction Non-invasive
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2021-05-24
Enrollment: 110
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to generate data that conveys participant's experiences such as their satisfaction with treatment delivered by the redesigned CoolSculpting® Elite system for non-invasive fat reduction in the midsection area (abdomen and flanks) in addition to optional body areas of upper arms, inner thighs, outer thighs and/or submental area. By doing this, the study will provide insights for doctors to better inform participants about the expected outcomes when one or more body areas are considered for treatment.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* Participant must be in good health as determined by medical history, physical examination, vital signs, and investigator's judgment, including no known active pandemic infection.
* Participant has clearly visible and palpable fat in the abdomen and flanks, and participant may also be assessed for visible and palpable fat in one or more of the following body areas: left and right lower aspects of the upper arms, left and right inner thigh, left and right outer thigh, or submental area, which in the investigator's opinion is appropriate for and may benefit from treatment.
* Participant has a BMI of ≥ 18.5 and \< 30. BMI is defined as weight in kilograms divided by height in meters squared (kg/m2).
* Participant agrees to maintain weight (ie, within 5% of body weight) by not making any changes in diet or exercise routine during the course of the study.
* Participant agrees to have photographs taken of the treatment area(s) during the scheduled time periods.

Exclusion Criteria:

* Participant has a history of an invasive fat reduction procedure (eg, liposuction, surgery, lipolytic agents, etc) within or adjacent to the area being considered for treatment.
* Participant has implants (eg, breast implants) in or immediately adjacent to the area of intended treatment.
* Participant has a history of prior surgery or scar tissue related to the area being considered for treatment.
* Participant has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
* Participant has a known sensitivity to cold or has any condition with a known response to cold exposure that limits blood flow to the skin, such as cold urticaria, Raynaud's disease, or chilblains (pernio).
* Participant with a clinically significant bleeding disorder, or concomitant use of blood thinners, or is taking any medication that, in the investigator's opinion, may significantly increase the participant's risk of bruising or bleeding.
* Participant has a history of carpal tunnel syndrome, compartment syndrome, or deep vein thrombosis in the upper or lower extremities (only applicable for participants receiving treatment to the upper arms or thighs).
* Participant is currently taking or has taken diet pills or weight control supplements within the past 6 months.
* Participant has any skin conditions, such as moderate to excessive skin laxity, open wound, or scars, and active infection, eczema, dermatitis or rashes in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks are not an exclusion).
* Participant has an active implanted device such as a pacemaker, defibrillator, drug delivery system, or any other metal-containing implant, within or adjacent to the area being considered for treatment.
* Participant (WOCBP- woman of childbearing potential) is pregnant or intending to become pregnant in the next 3 to 6 months and does not agree to use reliable contraception during the study.
* Participant is lactating or has been lactating in the past 6 months.
* Participant is unable or unwilling to comply with the study requirements.
* Participant is currently enrolled in a clinical study of any unapproved investigational device, investigational product, or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Participant has any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the participant's response or the integrity of the data or would pose an unacceptable risk to the participant.
* Participant has had a non-invasive fat reduction and/or body contouring procedure in the area(s) of intended treatment within the past 12 months.
* Participant needs to administer, or has a known history of subcutaneous injections, into the area(s) of intended treatment (eg, cortisone, heparin, insulin) within the past 6 months.
* Participant with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol.
* Participant has impaired peripheral circulation in the area to be treated.
* Participant has neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy.
* Participant has impaired skin sensation in or immediately adjacent to the treatment area(s).
* Participant has a history of hernia in or immediately adjacent to the treatment area(s).
* Participant diagnosed with a systemic fibrosing disease or fibrosis in the area intended or adjacent to the area to be treated.

Primary outcomes:
measure: Percentage of Participants With "Satisfied" or "Very Satisfied" on Item #1 for the CSQ (Cryolipolysis Satisfaction Questionnaire) - Midsection
timeFrame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)
measure: Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs
timeFrame: First treatment to Follow-up/Exit Visit (Week 12 + 14 days for those participants who received only 1 treatment session and Week 20 + 14 days for those participants who received 2 treatment sessions)
Secondary outcomes:
measure: Percentage of Participants Who Received Treatment to Abdomen and Flank and One or More Additional Body Areas for Treatment With "Satisfied" or "Very Satisfied" on CSQ-Overall Item 1
timeFrame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)
measure: Percentage of Participants With "Satisfied" or "Very Satisfied" on Individual Treated Body Areas (Upper Arms, Inner Thighs, Outer Thighs, Fat Under Chin) CSQ Item 1
timeFrame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)
measure: Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers
timeFrame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who recieved 2 treatment sessions)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser & Skin Surgery Medical group, Inc /ID# 239112
state: California
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology /ID# 239110
state: California
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology /ID# 239111
state: California
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York /ID# 239113
state: New York
city: Paris
country: France
facility: Centre Laser International de la Peau /ID# 239117
city: Lindau
country: Germany
facility: Bodenseeklinik /Id# 239155
city: Singapore
country: Singapore
facility: Halley Medical Aesthetics /ID# 239124
city: Stockholm
country: Sweden
facility: Akademikliniken /ID# 239120
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: