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NCT00764257 · ClinicalTrials.gov registry record · Phase 3
PREVELLE Shape (CX002) Dermal Filler Protocol
A Phase 3 study of Correction of Nasolabial Folds and Lip Augmentation, sponsored by Mentor Worldwide.
- Completed
- Registry status
- Phase 3
- Development phase
- 1
- Study location
NCT00764257: Completed Phase 3 study of Correction of Nasolabial Folds and Lip Augmentation, sponsored by Mentor Worldwide.
NCT00764257 is a Phase 3 study of Correction of Nasolabial Folds and Lip Augmentation that has completed, run by Mentor Worldwide. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00764257, a Phase 3 study of Correction of Nasolabial Folds and Lip Augmentation, has completed, sponsored by Mentor Worldwide.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1
- Study location
Study Summary
The purpose of this study was to assess PREVELLE Shape (CX002), with respect to safety and efficacy for one year following treatment, for correction of facial nasolabial folds and when applied as an intradermal implant for lip augmentation.
Primary Outcome
The primary aim of the study is to assess CX002, with respect to safety and efficacy during the six months following treatment, in two subject cohorts: 1. When applied as an intradermal implant for the correction of facial nasolabial folds (Nasolabial Fold Cohort). Nasolabial folds were chosen as the fold/wrinkle for treatment as they are often the most severe facial wrinkles, representing a "worst-case" scenario 2. When applied as an intradermal implant for lip augmentation (Lip Augmentation C
Conditions Studied
Interventions
- DEVICE PREVELLE Shape
- DEVICE Restylane
Study Locations (1)
California
- Mentor Worldwide, LLC - Santa Barbara
Trial Details
| Field | Value |
|---|---|
| Start Date | 2004-10 |
| Est. Completion | 2007-01 |
| Phase | Phase 3 |
What the finished NCT00764257 record still lists
NCT00764257 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
The record links to 1 condition, with Correction of Nasolabial Folds and Lip Augmentation appearing as the primary indexed condition, and to 2 interventions - of which PREVELLE Shape is the first listed.
NCT00764257 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00764257 about?
NCT00764257 is a clinical study titled "PREVELLE Shape (CX002) Dermal Filler Protocol". The purpose of this study was to assess PREVELLE Shape (CX002), with respect to safety and efficacy for one year following treatment, for correction of facial nasolabial folds and when applied as an intradermal implant for lip augmentation.
What is the current status of trial NCT00764257?
This trial is currently completed. It is a Phase 3 study. The study started on 2004-10. Estimated completion is 2007-01.
What conditions does trial NCT00764257 study?
This clinical trial studies the following conditions: Correction of Nasolabial Folds and Lip Augmentation.
What interventions are being tested in trial NCT00764257?
The interventions under investigation include: PREVELLE Shape (DEVICE), Restylane (DEVICE).
Who is sponsoring clinical trial NCT00764257?
This trial is sponsored by Mentor Worldwide, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00764257 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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