Improved Appearance of the Banana Roll Region
Conditions
Brief 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).
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.
Interventions
DEVICECoolSculpting Elite combined with CoolTone Treatments
Coolsculpting treatment combined with Cooltone treatments for the banana roll region of the buttocks.
DEVICECoolSculpting Elite
Coolsculpting treatment alone for the banana roll region of the buttocks
Sponsors
Goldman, Butterwick, Fitzpatrick and Groff
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 65 Years
Healthy volunteers
Yes
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| appearance of the banana roll region based on Investigator Global Aesthetic Improvement Scales | 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 |
| Improvement in Appearance of the Banana Roll Region Based on Clinical Photographs | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Treatment Satisfaction Survey | 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 |
| Subject Global Aesthetic Improvement Scale | 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 |
Countries
United States
Outcome results
None listed