International CoolSculpting: Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)

• ClinicalTrials.gov Identifier: NCT03909100
• Recruitment Status: Completed
• First Posted: April 9, 2019
• Results First Posted: March 22, 2021
• Last Update Posted: March 22, 2021
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

Brief Summary:

This study aims to generate data that conveys participant's experiences such as their overall satisfaction with the CoolSculpting® treatment for their belly and love handles. By doing this, the study will provide insights for doctors to better inform participants about the expected outcomes.

Condition or disease	Intervention/treatment	Phase
Non-invasive Fat Reduction	Device: CoolSculpting® System	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: International CoolSculpting: Prospective, Multi-Country, Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)
• Actual Study Start Date: July 29, 2019
• Actual Primary Completion Date: February 28, 2020
• Actual Study Completion Date: February 28, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: CoolSculpting® System; Participants received up to two CoolSculpting® treatment sessions for the abdomen, flanks or both 8 weeks apart. A treatment session was comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage. Up to 12 cycles per treatment session were performed at the investigator's discretion.	Device: CoolSculpting® System; A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Who Reported "Satisfied" or "Very Satisfied" on Cryolipolysis Satisfaction Questionnaire (CSQ) Item #1 Overall [ Time Frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions) ]
   The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1="Rate your overall satisfaction with the fat reduction procedure on the treated area" using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied.

Secondary Outcome Measures :

1. Percentage of Participants Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 in Treated Area(s) [ Time Frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions) ]
   The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1="Rate your overall satisfaction with the fat reduction procedure on the treated area" using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied.
2. Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles [ Time Frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions) ]
   The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1="Rate your overall satisfaction with the fat reduction procedure on the treated area" using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied.
3. Percentage of Participants by Body Mass Index (BMI) Categories Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 [ Time Frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions) ]
   The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1="Rate your overall satisfaction with the fat reduction procedure on the treated area" using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied. Participants were analyzed based on BMI ranges from 18.5 to < 25.0 and 25.0 to < 30.0. BMI was defined as weight in kilograms divided by height in meters squared (kg/m^2).
4. Change From Baseline in Volume of Fat as Measured by 3 Dimensional (3D) Photography [ Time Frame: Baseline to 8 Weeks post-Treatment 1 and 12 Weeks post-Final Treatment 2 ]
   Change in the volume of fat was assessed by a 3D stereoscopic camera which was used to generate a 3D image of the body, allowing quantification of the abdomen and flank areas. A 2-step 3D matching algorithm process was used, to identify the change of volume in milliliters (mL).
5. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments) ]
   An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users, or other persons, if related to the investigational medical device. A SAE is any AE, that is fatal, life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. A TEAE is defined as any new adverse event or worsening of an existing condition after initiation of treatment.
6. Percentage of Participants With Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) [ Time Frame: First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments) ]
   An ADE was defined in accordance with ISO 14155 as an AE related to the use of an investigational medical device or defined as AE with a reasonable possibility (Possible, Probable, or Causal relationship) that the device caused the event. SADE is an ADE that might have led to any SAE consequences if a suitable action had not been taken or intervention had not been made.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Participant has clearly visible fat in the flanks and/or abdomen, which in the investigator's opinion, may benefit from the treatment.
• Participant has not had weight change fluctuations exceeding 4.5 kg (or 5% of body weight) in the preceding month.
• Participant has a body mass index (BMI) of 18.5 to 30. A 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 had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment.
• 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 is pregnant or intending to become pregnant.
• Participant is lactating or has been lactating in the past 6-9 months.
• Participant is unable or unwilling to comply with 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 an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant.
• Participant with known history of cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
• Participant with 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 or Raynaud's disease, or Chilblains (pernio).
• Participant with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol.
• Participant with impaired peripheral circulation in the area to be treated
• Participant with neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy.
• Participant with impaired skin sensation.
• Participant with open or infected wounds.
• Participant with bleeding disorders, or concomitant use of blood thinners, or is taking any medication that in the investigator's opinion may increase the participant's risk of bruising.
• Participant with recent surgery or scar tissue in the area to be treated.
• Participant has history of hernia in or adjacent to the treatment area(s) site.
• Participant with skin conditions such as eczema, dermatitis, or rashes in the area to be treated.
• Participant 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).
• Participant is taking or has taken diet pills or supplements within the past 6 months.
• 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 diagnosed with fibrosis.

Contacts and Locations

Locations

Australia, Victoria

Sandhurt Plastic Surgery

Bendigo, Victoria, Australia, 3550

Australia, Western Australia

Academy Face and Body

Subiaco, Western Australia, Australia, 6008

Canada, British Columbia

Vancouver Laser & Skin Care Centre

Vancouver, British Columbia, Canada, V5Z 1H2

Singapore

Halley Medical Aesthetics

Singapore, Singapore, 238858

Dr Benjamin Yim Clinical Aesthetics and Laser Centre

Singapore, Singapore, 238884

United Kingdom

Revere Riverside Ltd

Northwood, Middlesex, United Kingdom, HA6 2NP

Revere Clinics

London, United Kingdom, W1G 7JA

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Esther Jo; Allergan

  Study Documents (Full-Text)

Documents provided by Allergan:

Study Protocol  [PDF] November 20, 2019

Statistical Analysis Plan  [PDF] October 6, 2018

More Information

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT03909100
• Other Study ID Numbers: CMO-MA-PLS-0602
• First Posted: April 9, 2019
• Results First Posted: March 22, 2021
• Last Update Posted: March 22, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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.: Yes