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NCT00716443 · ClinicalTrials.gov registry record · Phase 4
Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections
A Phase 4 study, sponsored by Galderma R&D.
- Terminated
- Registry status
- Phase 4
- Development phase
- 51
- Enrollment target
NCT00716443: Clinical Trial Phase 4 study, sponsored by Galderma R&D.
NCT00716443 is a Phase 4 study that was terminated before completion, run by Galderma R&D. The registered enrollment target is 51 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00716443, a Phase 4 study, was terminated before completion, sponsored by Galderma R&D.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 51 participants
- Enrollment target
Study Summary
Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane® injections for the correction of nasolabial folds.
Primary Outcome
Subject's pain as evaluated using a VAS scale from 0 - 10 cm (centimeters) with 0 cm being no pain and 10 cm being the worst pain imaginable upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds
Interventions
- DRUG tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream)
- DRUG benzocaine 20% / lidocaine 6% / tetracaine 4% ointment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2008-07 |
| Est. Completion | 2008-09 |
| Phase | Phase 4 |
Why NCT00716443 stopped before completion
NCT00716443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream) is the first listed.
NCT00716443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00716443 about?
NCT00716443 is a clinical study titled "Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections". Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane® injections for the correction of nasolabial folds.
What is the current status of trial NCT00716443?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 51 participants. The study started on 2008-07. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00716443?
The interventions under investigation include: tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream) (DRUG), benzocaine 20% / lidocaine 6% / tetracaine 4% ointment (DRUG).
Who is sponsoring clinical trial NCT00716443?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00716443's enrollment target sits among peer trials
51 1249th of 2000 higher than 746 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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