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NCT00444626 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 140
- Enrollment target
NCT00444626 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 140 participants.
The verdict
NCT00444626, a Phase 3 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 140 participants
- Enrollment target
Study Summary
The purpose of this research study is to evaluate the safety and effectiveness of injection with DGE Injectable Gel (hyaluronic acid with lidocaine manufactured by Genzyme Biosurgery) as compared to injection with Restylane (a Food and Drug Administration (FDA) approved dermal filler) in patients undergoing cutaneous correction of the nasolabial folds (NLFs).
Interventions
- DEVICE Restylane
- DRUG EMLA Cream
- DEVICE Dermal Gel Extra (DGE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2007-05 |
| Est. Completion | 2008-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00444626
The ClinicalTrials.gov registry entry for NCT00444626 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Restylane is the first listed.
NCT00444626 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00444626 about?
NCT00444626 is a clinical study titled "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)". The purpose of this research study is to evaluate the safety and effectiveness of injection with DGE Injectable Gel (hyaluronic acid with lidocaine manufactured by Genzyme Biosurgery) as compared to injection with Restylane (a Food and Drug Administration (FDA) approved dermal filler) in patients un...
What is the current status of trial NCT00444626?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2007-05. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00444626?
The interventions under investigation include: Restylane (DEVICE), EMLA Cream (DRUG), Dermal Gel Extra (DGE) (DEVICE).
Who is sponsoring clinical trial NCT00444626?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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