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Primary objective To evaluate the degree of correction achievable with Sculptra for nasolabial folds, mid- and lower facial volume loss, jawline laxity and other signs of facial ageing.
To document the types and incidence of device-related adverse events with Sculptra.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poly-L-Lactic Acid | Drug | Deep dermal injection |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the degree of correction attainable with Sculptra (injectable PLLA) for the correction of nasolabial folds, mid-and lower facial volume loss, jawline laxicity, and other signs of facial aging. | From baseline to 6-months post-Sculptra therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Document the types and incidence of device adverse events with Sculptra Therapy (Injectable PLLA) | From baseline to 6-months post-Sculptra therapy |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Mary Tzortzis | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Québec | Canada |
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| ID | Term |
|---|---|
| C033616 | poly(lactide) |
| C482305 | New-Fill |
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