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| Name | Class |
|---|---|
| Inamed Aesthetics | INDUSTRY |
To assess the likelihood of keloid and scar formation, pigmentation disorders and hypersensitivity reactions in patients with skin of color undergoing correction of facial soft tissue contour deficiencies with Hylaform, Hylaform Plus or Captique.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hylaform, Hylaform Plus (hylan B gel) | Device |
| Measure | Description | Time Frame |
|---|---|---|
| no difference in keloid and scar formation | ||
| pigmentation disorders | ||
| hypersensitivity reactions in patients with skin color compared to other patients when treated for wrinkle correction with Hylaform, Hylaform Plus or Captique |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitiligo & Pigmentation Institute of Southern California | Los Angeles | California | 90036 | United States | ||
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| Grekin Skin Institute |
| Warren |
| Michigan |
| 48088 |
| United States |
| Society Hill Dermatology | Philadelphia | Pennsylvania | 19107 | United States |