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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A=CoolSculpting Elite and CoolTone | Experimental | 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. |
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| GROUP B CoolSculpting Elite alone | Active Comparator | Group B: Study subjects will have a total of 1 or 2 bilateral CoolSculpting Elite sessions to the banana roll area. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoolSculpting Elite combined with CoolTone Treatments | Device | Coolsculpting treatment combined with Cooltone treatments for the banana roll region of the buttocks. |
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| Measure | Description | Time Frame |
|---|---|---|
| appearance of the banana roll region based on Investigator Global Aesthetic Improvement Scales | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Treatment Satisfaction Survey | 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 |
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Inclusion Criteria:
Inclusion Criteria
Exclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Dermatology Research Center/Cosmetic Laser Dermatology | Recruiting | San Diego | California | 92121 | United States |
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| CoolSculpting Elite | Device | Coolsculpting treatment alone for the banana roll region of the buttocks |
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| Improvement in Appearance of the Banana Roll Region Based on Clinical Photographs |
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 |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| West Dermatology Research Center/Cosmetic Laser Dermatology | Recruiting | San Diego | California | 92121 | United States |
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