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

NCT03909100 | Completed Results FDA Device

• 1 other identifier: CMO-MA-PLS-0602
• Study Type: interventional
• Target: 120
• Locations: 4 countries
• Sites: 7

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.

Conditions

Non-invasive Fat Reduction

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Reported "Satisfied" or "Very Satisfied" on Cryolipolysis Satisfaction Questionnaire (CSQ) Item #1 Overall

  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.

  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)

Secondary Outcomes (6)

• Percentage of Participants Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 in Treated Area(s)

  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)

• Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles

  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)

• Percentage of Participants by Body Mass Index (BMI) Categories Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1

  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)

• Change From Baseline in Volume of Fat as Measured by 3 Dimensional (3D) Photography

  Baseline to 8 Weeks post-Treatment 1 and 12 Weeks post-Final Treatment 2

• Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  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)

Study Arms (1)

CoolSculpting® System

EXPERIMENTAL

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

Interventions

CoolSculpting® System DEVICE

A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.

CoolSculpting® System

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (7)

Sandhurt Plastic Surgery

Bendigo, Victoria, 3550, Australia

Location

Academy Face and Body

Subiaco, Western Australia, 6008, Australia

Location

Vancouver Laser & Skin Care Centre

Vancouver, British Columbia, V5Z 1H2, Canada

Location

Halley Medical Aesthetics

Singapore, 238858, Singapore

Location

Dr Benjamin Yim Clinical Aesthetics and Laser Centre

Singapore, 238884, Singapore

Location

Revere Riverside Ltd

Northwood, Middlesex, HA6 2NP, United Kingdom

Location

Revere Clinics

London, W1G 7JA, United Kingdom

Location

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Esther Jo

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: April 9, 2019
• Study Start: July 29, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: June 27, 2023
• Results First Posted: March 22, 2021

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2); AU (2); GB (2); CA (1)