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The purpose of this study is to determine if Perlane-L is safe in increasing cheek volume.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perlane-L | Experimental | Perlane-L treatment |
|
| Non-Treatment | Sham Comparator | Non-Treatment Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perlane-L | Device | Perlane-L Injection in the midface |
| |
| Non-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Facial fullness using midface scale | Change in facial fullness using midface scale. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Facial fullness using the midface scale | Change in facial fullness using midface scale. | Up to 12-months post treatment |
| Subject satisfaction using the GAIS | Compare treatment satisfaction as compared to no treatment, on the Global Aesthetic Improvement Scale (GAIS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills | California | United States | ||||
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| Other |
Non-treatment Arm |
|
| Up to 12-months post treatment |
| Aesthetic improvement | A subjective assessment of aesthetic improvement post baseline | Up to 12-months post treatment |
| San Francisco |
| California |
| United States |
| Vista | California | United States |
| Aventura | Florida | United States |
| Coral Gables | Florida | United States |
| Chicago | Illinois | United States |
| Hunt Valley | Maryland | United States |
| Chestnut Hill | Massachusetts | United States |
| Mount Kisco | New York | United States |
| New York | New York | United States |
| Eugene | Oregon | United States |