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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sculptra |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DL6049 (injectable poly-L-lactic acid) | Device | Subjects will be treated with SCULPTRA® every 4-6 weeks in accordance with SCULPTRA® package insert |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the mean change from baseline in Nasolabial volume as measured by 3-D digital surface imaging | 6 months | |
| Correlate volumetric correction with clinical improvement as measured by the Dermik Nasolabial Photo-numeric Scale. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with signs of facial contour deficiencies in the area of the nasolabial folds [nasolabial fold scores greater than or equal to 2 (bilaterally) on the Dermik Nasolabial Photo-numeric Scale.](streamdown:incomplete-link)
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| Name | Affiliation | Role |
|---|---|---|
| Phyllis Diener, MT, ASCP | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | United Kingdom |
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| Correlate the mean volumetric change in mid-facial treatment area with the amount of product used. | 6 months |
| Determine mean change from baseline in the contour deficiency score as determined by the investigator. | 6 months |
| Investigator Global Assessment of Improvement - Excellent Improvement | 6 months |
| Investigator Global Assessment of Improvement - Much Improved | 6 Months |
| Investigator Global Assessment of Improvement - Improved | 6 Months |
| Investigator Global Assessment of Improvement - No Change | 6 Months |
| Investigator Global Assessment of Improvement - Worse | 6 Months |
| Subject Global Assessment of Improvement - Excellent Improvement | 6 Months |
| Subject Global Assessment of Improvement - Much Improved | 6 Months |
| Subject Global Assessment of Improvement - Improved | 6 Months |
| Subject Global Assessment of Improvement - No Change | 6 Months |
| Subject Global Assessment of Improvement - Worse | 6 Months |