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

NCT04142450 | Completed Results FDA Device

• 1 other identifier: MED-MA-PLS-0633
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Body Fat Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (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

  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

  Week 12

• Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Upper Arms

  Baseline (Day 1) to Week 12

• Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Inner Thighs

  Baseline (Day 1) to Week 12

Study Arms (1)

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.

Device: CoolSculpting® System

Interventions

CoolSculpting® System DEVICE

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

CoolSculpting® System

Eligibility Criteria

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

You may qualify if:

• Participant (healthy volunteers) has read and signed the study written informed consent form (ICF)
• st 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.

You may not qualify if:

• 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.
• Participant is currently taking or has taken diet pills or weight control supplements within the past 6 months.
• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (3)

Vancouver Laser and Skin Care Clinic

Vancouver, British Columbia, V5Z 1H2, Canada

Location

Project Skin MD

Vancouver, British Columbia, V6H 1K9, Canada

Location

Pacific Derm

Vancouver, British Columbia, V6H 4E1, Canada

Location

Related Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com.
• To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Matthew Hickling

  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
• Masking Details: This is an open-label study. Blinding will only be employed for photograph review by an independent panel of physician reviewers with expertise in the areas of dermatology and/or plastic surgery.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: October 27, 2019
• Primary Completion: February 24, 2020
• Study Completion: February 24, 2020
• Last Updated: April 1, 2021
• Results First Posted: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After having 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.
• Access Criteria: 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.

Locations

CA (3)