Clinical trial
A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device…
NCT00444626 · Genzyme, a Sanofi Company, Industry · Completed
Key facts
| NCT number | NCT00444626 |
|---|---|
| Title | A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device Dermal Gel Extra (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs) |
| Official title | A Subject- and Evaluator-Blinded, Randomized, Multi-Center Study to Evaluate the Safety and Effectiveness of Injection With DGE Injectable Gel as Compared to an FDA-Approved Dermal Filler in Subjects Undergoing Cutaneous Correction of Nasolabial Folds |
| Lead sponsor | Genzyme, a Sanofi Company, Industry |
| Collaborators | Mentor Worldwide, LLC Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Facial Wrinkles at the Nasolabial Folds |
| Intervention type | Device, Drug |
| Interventions | Dermal Gel Extra (DGE), Restylane, EMLA Cream |
| Enrollment | 140 |
| Start date | May 1, 2007 |
| Primary completion | Feb 1, 2008 |
| Completion | Jul 1, 2008 |
| First posted | Mar 8, 2007 |
| Last update posted | Apr 22, 2015 |
| Countries | United States |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: