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NCT00417469 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Subject Comfort During and After Injections With the Study Products and the Safety of the Non-FDA Approved Product for the Correction of Nasolabial Folds (NLFs)
A Phase 3 study of Facial Wrinkles, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT00417469: Completed Phase 3 study of Facial Wrinkles, sponsored by Genzyme, a Sanofi Company.
NCT00417469 is a Phase 3 study of Facial Wrinkles that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 45 participants, below the 80-participant average among 6 other Facial Wrinkles trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00417469, a Phase 3 study of Facial Wrinkles, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to compare subject comfort during and after injection with NADGL and Captique® Injectable Gel, in the nasolabial folds. Captique® is an FDA-approved product without lidocaine and is manufactured by Genzyme Biosurgery (Ridgefield, NJ). NADGL is a new product (not FDA approved) with lidocaine and is also manufactured by Genzyme Biosurgery. We do not know which of these treatments results in less pain during and after injection. The safety of NADGL is also being studied.
Conditions Studied
Interventions
- DEVICE NADGL
Study Locations (1)
Alabama
- - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2007-01 |
| Est. Completion | 2007-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00417469
The ClinicalTrials.gov registry entry for NCT00417469 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 80-participant average among 6 other Facial Wrinkles trials with a reported enrollment target (44% lower). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Facial Wrinkles appearing as the primary indexed condition, and to 1 intervention - of which NADGL is the first listed.
NCT00417469 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.
Frequently Asked Questions
What is clinical trial NCT00417469 about?
NCT00417469 is a clinical study titled "A Study to Compare Subject Comfort During and After Injections With the Study Products and the Safety of the Non-FDA Approved Product for the Correction of Nasolabial Folds (NLFs)". The purpose of this research study is to compare subject comfort during and after injection with NADGL and Captique® Injectable Gel, in the nasolabial folds. Captique® is an FDA-approved product without lidocaine and is manufactured by Genzyme Biosurgery (Ridgefield, NJ). NADGL is a new product (not...
What is the current status of trial NCT00417469?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 45 participants. The study started on 2007-01. Estimated completion is 2007-02.
What conditions does trial NCT00417469 study?
This clinical trial studies the following conditions: Facial Wrinkles.
What interventions are being tested in trial NCT00417469?
The interventions under investigation include: NADGL (DEVICE).
Who is sponsoring clinical trial NCT00417469?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00417469 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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