Coolsculpting With Cooltone Verses Coolsculpting Alone for the Banana Roll Area

April 28, 2022 updated by: Goldman, Butterwick, Fitzpatrick and Groff

A Single-centered Randomized Single-blinded Clinical Trial to Evaluate Efficacy and Safety of Sequential Treatment of CoolSculpting Elite With CoolTone vs. CoolSculpting Elite Alone in Treating the Banana Roll Region

to evaluate the benefit and efficacy of CoolSculpting Elite study treatments versus CoolSculpting Elite study treatments followed by a series CoolTone for underneath the buttocks (also known as the banana roll).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Investigate safety and efficacy of CoolSculpting Elite treatments for underneath the buttocks (also known as the banana roll) versus sequential treatments of CoolSculpting Elite and CoolTone for the banana roll region.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Recruiting
        • West Dermatology Research Center/Cosmetic Laser Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Inclusion Criteria

    1. Female ≥ 22 years and ≤65 years of age.
    2. Subject has not had weight change exceeding 5% of body weight in the preceding month.
    3. Subject agrees to maintain body weight within 5% during the study by not making any changes in diet or exercise routine.
    4. Subject has a BMI ≤ 30 as determined at screening.
    5. Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.
    6. Subject agrees to refrain from any new or change in gluteal muscle training exercises of the treatment area during the course of the study.
    7. Subject agrees to avoid sun tanning or spray tanning during the course of the study. Subject has read and signed the study written informed consent form

Exclusion Criteria:

  • Exclusion Criteria

    1. Male Subjects
    2. Subject has had a recent surgical procedure(s) in the area of intended treatment and muscle contractions may disrupt the healing process.
    3. A subject with any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
    4. A subject with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
    5. Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) non-invasive fat reduction or skin tightening procedures , or cellulite treatment in the area of intended treatment
    6. Subjects who tanned or spray tanned in the treatment area within the past 4 weeks
    7. A subject with history of or the presence of any skin condition/disease in the treatment area that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis) at the discretion of the investigator.
    8. Subject needs to administer or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month
    9. Subject hashad an intrauterine contraceptive device inserted or removed within the past month.
    10. A subject with an active bacterial, fungal, or viral infection in the treatment area.
    11. Subject has a bleeding disorder
    12. Subject has a blood disorder such as cryoglobulinemia, cold agglutinin disease and paroxysmal cold hemoglobinuria.
    13. Known sensitivity to cold such as cold urticaria, Raynaud's disease, pernio or Chilblains. Or patients with any impaired sensation in treated area
    14. A subject with scarring or tattoos in the treatment area that might interfere with the diagnosis or study evaluations at the discretion of the investigator.
    15. Subject is taking or has taken diet pills or supplements within the past month.
    16. Subject has a metal implant or active implanted device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system.
    17. Subject has pulmonary insufficiency.
    18. Subject has a cardiac disorder.
    19. Subject has a malignant tumor.
    20. Subject has been diagnosed with a seizure disorder such as epilepsy.
    21. Subject currently has a fever.
    22. Subject is diagnosed with Grave's disease.
    23. Subject is pregnant or intending to become pregnant during the study period (in the next 9 months).
    24. Subject is lactating or has been lactating in the past 6 months.
    25. Subject is unable or unwilling to comply with the study requirements.
    26. Subject is currently enrolled in a clinical study of any other investigational drug or device.
    27. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
    28. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: GROUP A=CoolSculpting Elite and CoolTone
Group A: Study subjects will have a total of 1 or 2 bilateral CoolSculpting Elite sessions to the banana roll area 6 weeks prior to four EMMS treatment sessions during the study.
Device: CoolSculpting Elite combined with CoolTone Treatments
Coolsculpting treatment combined with Cooltone treatments for the banana roll region of the buttocks.
ACTIVE_COMPARATOR: GROUP B CoolSculpting Elite alone
Group B: Study subjects will have a total of 1 or 2 bilateral CoolSculpting Elite sessions to the banana roll area.
Device: CoolSculpting Elite
Coolsculpting treatment alone for the banana roll region of the buttocks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
appearance of the banana roll region based on Investigator Global Aesthetic Improvement Scales
Time Frame: baseline to 6-weeks
Investigator Global Aesthetic Improvement Scale Scores will be assigned where -3 = Very Much Worse, -2 = Much Worse -, -1 = Worse, 0 = No Chance, 1 = Improved, 2 = Much Improved, 3 = Very Much Improved
baseline to 6-weeks
appearance of the banana roll region based on Investigator Global Aesthetic Improvement Scales
Time Frame: baseline to 7-weeks
Investigator Global Aesthetic Improvement Scale Scores will be assigned where -3 = Very Much Worse, -2 = Much Worse -, -1 = Worse, 0 = No Chance, 1 = Improved, 2 = Much Improved, 3 = Very Much Improved
baseline to 7-weeks
appearance of the banana roll region based on Investigator Global Aesthetic Improvement Scales
Time Frame: baseline to 12-weeks
Investigator Global Aesthetic Improvement Scale Scores will be assigned where -3 = Very Much Worse, -2 = Much Worse -, -1 = Worse, 0 = No Chance, 1 = Improved, 2 = Much Improved, 3 = Very Much Improved
baseline to 12-weeks
appearance of the banana roll region based on Investigator Global Aesthetic Improvement Scales
Time Frame: baseline to 13-weeks
Investigator Global Aesthetic Improvement Scale Scores will be assigned where -3 = Very Much Worse, -2 = Much Worse -, -1 = Worse, 0 = No Chance, 1 = Improved, 2 = Much Improved, 3 = Very Much Improved
baseline to 13-weeks
appearance of the banana roll region based on Investigator Global Aesthetic Improvement Scales
Time Frame: baseline to 18-weeks
Investigator Global Aesthetic Improvement Scale Scores will be assigned where -3 = Very Much Worse, -2 = Much Worse -, -1 = Worse, 0 = No Chance, 1 = Improved, 2 = Much Improved, 3 = Very Much Improved
baseline to 18-weeks
Improvement in Appearance of the Banana Roll Region Based on Clinical Photographs
Time Frame: 18 Weeks
Investigator Global Aesthetic Improvement Scale Scores where -3 = Very Much Worse, -2 = Much Worse -, -1 = Worse, 0 = No Chance, 1 = Improved, 2 = Much Improved, 3 = Very Much Improved will be assigned by a blinded assessor based on photographs
18 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Treatment Satisfaction Survey
Time Frame: baseline to 1-Week
Subject rating of treatment satisfaction where - 3 = Completely Dissatisfied, -2 = Moderately Dissatisfied, -1 = Mildly Dissatisfied, 0 = Neither Satisfied nor Dissatisfied, 1 = Mildly Satisfied, 2 = Moderately Satisfied, 3 =Completely Satisfied
baseline to 1-Week
Patient Treatment Satisfaction Survey
Time Frame: baseline to 6-weeks
Subject rating of treatment satisfaction where - 3 = Completely Dissatisfied, -2 = Moderately Dissatisfied, -1 = Mildly Dissatisfied, 0 = Neither Satisfied nor Dissatisfied, 1 = Mildly Satisfied, 2 = Moderately Satisfied, 3 =Completely Satisfied
baseline to 6-weeks
Patient Treatment Satisfaction Survey
Time Frame: baseline to 7-weeks
Subject rating of treatment satisfaction where - 3 = Completely Dissatisfied, -2 = Moderately Dissatisfied, -1 = Mildly Dissatisfied, 0 = Neither Satisfied nor Dissatisfied, 1 = Mildly Satisfied, 2 = Moderately Satisfied, 3 =Completely Satisfied
baseline to 7-weeks
Patient Treatment Satisfaction Survey
Time Frame: baseline to 12-weeks
Subject rating of treatment satisfaction where - 3 = Completely Dissatisfied, -2 = Moderately Dissatisfied, -1 = Mildly Dissatisfied, 0 = Neither Satisfied nor Dissatisfied, 1 = Mildly Satisfied, 2 = Moderately Satisfied, 3 =Completely Satisfied
baseline to 12-weeks
Patient Treatment Satisfaction Survey
Time Frame: baseline to 13-weeks
Subject rating of treatment satisfaction where - 3 = Completely Dissatisfied, -2 = Moderately Dissatisfied, -1 = Mildly Dissatisfied, 0 = Neither Satisfied nor Dissatisfied, 1 = Mildly Satisfied, 2 = Moderately Satisfied, 3 =Completely Satisfied
baseline to 13-weeks
Patient Treatment Satisfaction Survey
Time Frame: baseline to 18-weeks
Subject rating of treatment satisfaction where - 3 = Completely Dissatisfied, -2 = Moderately Dissatisfied, -1 = Mildly Dissatisfied, 0 = Neither Satisfied nor Dissatisfied, 1 = Mildly Satisfied, 2 = Moderately Satisfied, 3 =Completely Satisfied
baseline to 18-weeks
Subject Global Aesthetic Improvement Scale
Time Frame: baseline to 6-weeks
Subject rating of treatment results where where -3 = Very Much Worse, -2 = Much Worse -, -1 = Worse, 0 = No Chance, 1 = Improved, 2 = Much Improved, 3 = Very Much Improved
baseline to 6-weeks
Subject Global Aesthetic Improvement Scale
Time Frame: baseline to 7-weeks
Subject rating of treatment results where where -3 = Very Much Worse, -2 = Much Worse -, -1 = Worse, 0 = No Chance, 1 = Improved, 2 = Much Improved, 3 = Very Much Improved
baseline to 7-weeks
Subject Global Aesthetic Improvement Scale
Time Frame: baseline to 12-weeks
Subject rating of treatment results where where -3 = Very Much Worse, -2 = Much Worse -, -1 = Worse, 0 = No Chance, 1 = Improved, 2 = Much Improved, 3 = Very Much Improved
baseline to 12-weeks
Subject Global Aesthetic Improvement Scale
Time Frame: baseline to 13-weeks
Subject rating of treatment results where where -3 = Very Much Worse, -2 = Much Worse -, -1 = Worse, 0 = No Chance, 1 = Improved, 2 = Much Improved, 3 = Very Much Improved
baseline to 13-weeks
Subject Global Aesthetic Improvement Scale
Time Frame: baseline to 18-weeks
Subject rating of treatment results where where -3 = Very Much Worse, -2 = Much Worse -, -1 = Worse, 0 = No Chance, 1 = Improved, 2 = Much Improved, 3 = Very Much Improved
baseline to 18-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Goldman, Butterwick, Fitzpatrick and Groff

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Coolsculpt-Cooltone-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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