Facial Wrinkles Clinical Trial
| Verified date | March 2015 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
A clinical study to investigate the safety and efficacy of Hylaform and Hylaform Plus for correction of facial wrinkles.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | August 2003 |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 30 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale Exclusion Criteria: - pregnant/lactating women - patients who previously received permanent facial implants or using ovet-the-counter products |
Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Genzyme, a Sanofi Company |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Non-inferiority as compared to standard of care as assigned by blinded reviewer. |
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