Body Fat DisorderNCT04142450

CoolSculpting® the Upper Arms and Inner Thighs in Participants of Chinese Descent (XinCOOL)

A study testing CoolSculpting® System in people with Body Fat Disorder, run by Allergan at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate the safety and effectiveness of the Allergan CoolSculpting® system using CoolAdvantage applicators for non-invasive subcutaneous fat reduction of the upper arms and inner thighs in participants of Chinese descent. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Body Fat Disorder
What is being tested?: CoolSculpting® System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 3 sitesCanada
Study dates: 27 Oct 2019to 24 Feb 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participant (healthy volunteers) has read and signed the study written informed consent form (ICF)
1st or 2nd generation, non-mixed race, Chinese descent.
Participant has clearly visible and palpable fat on the left and right lower aspects of the upper arms and/or left and right inner thighs, which in the investigator's opinion is appropriate and may benefit from the treatment.
Participant has not had weight change fluctuations exceeding 4.5 kilograms (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/m^2).
Participant agrees to maintain weight (i.e., 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.

Who cannot join

Participant has a history of an invasive fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or immediately adjacent to the area of intended treatment.
Participant has a history of prior surgery or scar tissue on the arms and/or inner thighs 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 oral or subcutaneous anticoagulants, or is taking any medication that in the investigator's opinion may significantly increase the participant's risk of bruising.
Participant with a history of carpal tunnel syndrome, compartment syndrome, or deep vein thrombosis in the upper or lower extremities.

Show all 23Show fewer

Participant is currently taking or has taken diet pills or weight control supplements within the past 6 months.
Participant has any dermatological conditions, such as moderate to excessive skin laxity, infection, open wound, or scars 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 is pregnant or intending to become pregnant in the next 3 months.
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 (e.g., cortisone, heparin, insulin) within the past 6 months.
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 a history of hernia in or adjacent to the treatment area(s) site.
Participant with a skin condition such as eczema, dermatitis, or rashes in the area to be treated.
Participant diagnosed with a systemic fibrosing disease or fibrosis in the area intended or adjacent to the area to be treated.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

Vancouver Laser and Skin Care Clinic
Vancouver, British Columbia, V5Z 1H2
Project Skin MD
Vancouver, British Columbia, V6H 1K9
Pacific Derm
Vancouver, British Columbia, V6H 4E1

Other trials in Canada

About this study

Conditions: Body Fat Disorder
Being tested: CoolSculpting® System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CoolSculpting® SystemDevice
Each participant underwent a single treatment session that was comprised of timed segments of cooling followed by 2 minutes of manual massage.

Study groups in NCT04142450
Study group	Role	What they receive
CoolSculpting® System	Experimental	Participants underwent a single CoolSculpting® treatment session on Day 1 that was comprised of timed segments of cooling followed by 2 minutes of manual massage. Each treated arm had up to two timed segments (or cycles) in the treatment session, each treated thigh had one timed segment (or cycle) in the treatment session. Receives: Device: CoolSculpting® System

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Arms With Correct Identification of Baseline Versus 12-week Treatment Images of the Upper Arms by at Least Two Out of Three Blinded, Independent Reviewers
Baseline versus 12-week images of the participants' left and right upper arms were assessed separately by the reviewers. Success was defined as at least 75% correct identification of the pre-treatment images of the upper arms.
Measured: Baseline (Day 1) to Week 12

Secondary outcomes (5)

Percentage of Thighs With Correct Identification of Baseline Versus 12-week Treatment Images of the Inner Thighs by at Least Two Out of Three Blinded, Independent Reviewers
Baseline versus 12-week images of the participants' left and right thighs were assessed separately by the reviewers. Success was defined as at least 75% correct identification of the pre-treatment images of the inner thighs.
Measured: Baseline (Day 1) to Week 12
Number of Participants With a Response of 'Satisfied' or 'Very Satisfied' for Question 1 (Overall Satisfaction) on the CoolSculpting Participant Questionnaire at the 12-week Visit for the Upper Arms
Participants were asked to complete a survey upon completing the treatment to assess their level of satisfaction with the treatment. Participants selected one of five options: 'very satisfied', 'satisfied', 'neither satisfied nor dissatisfied', 'dissatisfied', or 'very dissatisfied'.
Measured: Week 12
Number of Participants With a Response of 'Satisfied' or 'Very Satisfied' for Question 1 (Overall Satisfaction) on the CoolSculpting Participant Questionnaire at the 12-week Visit for the Inner Thighs
Participants were asked to complete a survey upon completing the treatment to assess their level of satisfaction with the treatment. Participants selected one of five options: 'very satisfied', 'satisfied', 'neither satisfied nor dissatisfied', 'dissatisfied', or 'very dissatisfied'.
Measured: Week 12
Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Upper Arms
Caliper measurements of the treatment areas were taken at baseline and at 12-weeks post treatment. After the treatment area was identified and marked, the thickness of the fat layer was measured using a caliper at the middle of the fat bulge. For each treatment area, three measurements were taken and recorded. The average of the three measurements was calculated. A negative change from baseline indicates improvement.
Measured: Baseline (Day 1) to Week 12
Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Inner Thighs
Caliper measurements of the treatment areas were taken at baseline and at 12-weeks post treatment. After the treatment area was identified and marked, the thickness of the fat layer was measured using a caliper at the middle of the fat bulge. For each treatment area, three measurements were taken and recorded. The average of the three measurements was calculated. A negative change from baseline indicates improvement.
Measured: Baseline (Day 1) to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 201924 Feb 2020

First posted29 Oct 2019
Study start27 Oct 2019
Primary completion24 Feb 2020
Study completion24 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Body Fat DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04142450
Sponsor's protocol ID: MED-MA-PLS-0633
Status last verified: Mar 2021
First submitted: 25 Oct 2019
Last updated: 1 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CoolSculpting® the Upper Arms and Inner Thighs in Participants of Chinese Descent (XinCOOL)
ClinicalTrials.gov ID: NCT04142450
Acronym / sponsor ID: MED-MA-PLS-0633
Conditions: Body Fat Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 27 Oct 2019 (actual)
Primary completion: 24 Feb 2020 (actual)
Study completion: 24 Feb 2020 (actual)
First posted: 29 Oct 2019 (actual)
Results: Posted 1 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CoolSculpting® System	Experimental	Device: CoolSculpting® SystemParticipants underwent a single CoolSculpting® treatment session on Day 1 that was comprised of timed segments of cooling followed by 2 minutes of manual massage. Each treated arm had up to two timed segments (or cycles) in the treatment session, each treated thigh had one timed segment (or cycle) in the treatment session.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Participant (healthy volunteers) has read and signed the study written informed consent form (ICF)
1st or 2nd generation, non-mixed race, Chinese descent.
Participant has clearly visible and palpable fat on the left and right lower aspects of the upper arms and/or left and right inner thighs, which in the investigator's opinion is appropriate and may benefit from the treatment.
Participant has not had weight change fluctuations exceeding 4.5 kilograms (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/m^2).

Key exclusion criteria (23 listed)

Participant has a history of an invasive fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or immediately adjacent to the area of intended treatment.
Participant has a history of prior surgery or scar tissue on the arms and/or inner thighs 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 oral or subcutaneous anticoagulants, or is taking any medication that in the investigator's opinion may significantly increase the participant's risk of bruising.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CoolSculpting® SystemEach participant underwent a single treatment session that was comprised of timed segments of cooling followed by 2 minutes of manual massage.	Device	CoolSculpting® System

Primary outcome

Percentage of Arms With Correct Identification of Baseline Versus 12-week Treatment Images of the Upper Arms by at Least Two Out of Three Blinded, Independent Reviewers
Time frame: Baseline (Day 1) to Week 12
Baseline versus 12-week images of the participants' left and right upper arms were assessed separately by the reviewers. Success was defined as at least 75% correct identification of the pre-treatment images of the upper arms.

5 secondary outcomes

Percentage of Thighs With Correct Identification of Baseline Versus 12-week Treatment Images of the Inner Thighs by at Least Two Out of Three Blinded, Independent Reviewers
Time frame: Baseline (Day 1) to Week 12
Number of Participants With a Response of 'Satisfied' or 'Very Satisfied' for Question 1 (Overall Satisfaction) on the CoolSculpting Participant Questionnaire at the 12-week Visit for the Upper Arms
Time frame: Week 12
Number of Participants With a Response of 'Satisfied' or 'Very Satisfied' for Question 1 (Overall Satisfaction) on the CoolSculpting Participant Questionnaire at the 12-week Visit for the Inner Thighs
Time frame: Week 12
Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Upper Arms
Time frame: Baseline (Day 1) to Week 12
Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Inner Thighs
Time frame: Baseline (Day 1) to Week 12

Results and safety

Results posted to the registry on 1 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CoolSculpting® System	50	48

Primary outcome: Percentage of Arms With Correct Identification of Baseline Versus 12-week Treatment Images of the Upper Arms by at Least Two Out of Three Blinded, Independent Reviewers

Time frame: Baseline (Day 1) to Week 12. Number (95% Confidence Interval). Unit: percentage of arms

Measure	CoolSculpting® System n = 36
Value	76.4 (64.9 to 85.6)

Population analysed: Per Protocol Population, consisted of all treated participants followed for 12 weeks and with weight change of no more than 5% of total body weight at the time the 12-week images were taken. Overall number analyzed are the number of participants and number of arms treated per protocol with data available for analyses.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 Treatment to Week 12 +/- 14 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CoolSculpting® System	0 of 49 (0%)	0 of 49 (0%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.

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Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew Hickling study director

Allergan

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CoolSculpting® System in people with Body Fat Disorder, run by Allergan at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Arms With Correct Identification of Baseline Versus 12-week Treatment Images of the Upper Arms by at Least Two Out of Three Blinded, Independent Reviewers (time frame: Baseline (Day 1) to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04142450.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.