CoolSculpting Elite combined with CoolTone Treatments for Improved Appearance of the Banana Roll Region

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
West Dermatology Research Center/Cosmetic Laser Dermatology, San Diego, CA
Improved Appearance of the Banana Roll Region
CoolSculpting Elite combined with CoolTone Treatments - Device
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

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).

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Improved Appearance of the Banana Roll Region

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 18 Weeks

18 Weeks
Improvement in Appearance of the Banana Roll Region Based on Clinical Photographs
baseline to 18-weeks
Patient Treatment Satisfaction Survey
Subject Global Aesthetic Improvement Scale
appearance of the banana roll region based on Investigator Global Aesthetic Improvement Scales

Trial Safety

Safety Progress

1 of 3

Other trials for Improved Appearance of the Banana Roll Region

Trial Design

2 Treatment Groups

GROUP B CoolSculpting Elite alone
1 of 2
GROUP A=CoolSculpting Elite and CoolTone
1 of 2
Active Control
Experimental Treatment

15 Total Participants · 2 Treatment Groups

Primary Treatment: CoolSculpting Elite combined with CoolTone Treatments · No Placebo Group · N/A

GROUP A=CoolSculpting Elite and CoolTone
Device
Experimental Group · 1 Intervention: CoolSculpting Elite combined with CoolTone Treatments · Intervention Types: Device
GROUP B CoolSculpting Elite alone
Device
ActiveComparator Group · 1 Intervention: CoolSculpting Elite · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 weeks
Closest Location: West Dermatology Research Center/Cosmetic Laser Dermatology · San Diego, CA
Photo of san diego 1Photo of san diego 2Photo of san diego 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Improved Appearance of the Banana Roll Region
0 CompletedClinical Trials

Who is running the clinical trial?

Goldman, Butterwick, Fitzpatrick and GroffLead Sponsor
22 Previous Clinical Trials
480 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female and at least 22 years of age.
Subject has not had weight change exceeding 5% of body weight in the preceding month.
You have read and signed the study written informed consent form.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.