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NCT00444353 · ClinicalTrials.gov registry record · Phase 3
DL6049 Versus Cosmoplast in the Treatment of Nasolabial Fold Wrinkles, Long Term Follow-up
A Phase 3 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
NCT00444353: Completed Phase 3 study, sponsored by Bausch Health Americas.
NCT00444353 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 240 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00444353, a Phase 3 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
Study Summary
This study is being undertaken to: * evaluate the degree of correction attainable with DL6049 (injectable poly-L-lactic acid)compared to a commercially available CosmoPlast™ Collagen Implant in the treatment of dermal nasolabial fold wrinkles at 13 months following the last application of study treatment. * Document the types and incidence of adverse events reported with DL6049 (injectable poly-L-lactic acid)compared with CosmoPlast™ Collagen Implant. Long term adverse events will be assessed for an additional 12 months following discharge from the main study in subjects treated with DL6049.
Interventions
- DEVICE DL6049 (injectable poly-L-lactic acid)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2004-08 |
| Est. Completion | 2007-01 |
| Phase | Phase 3 |
What the finished NCT00444353 record still lists
NCT00444353 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 1 intervention - of which DL6049 (injectable poly-L-lactic acid) is the first listed.
NCT00444353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00444353 about?
NCT00444353 is a clinical study titled "DL6049 Versus Cosmoplast in the Treatment of Nasolabial Fold Wrinkles, Long Term Follow-up". This study is being undertaken to: * evaluate the degree of correction attainable with DL6049 (injectable poly-L-lactic acid)compared to a commercially available CosmoPlast™ Collagen Implant in the treatment of dermal nasolabial fold wrinkles at 13 months following the last application of study tre...
What is the current status of trial NCT00444353?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2004-08. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00444353?
The interventions under investigation include: DL6049 (injectable poly-L-lactic acid) (DEVICE).
Who is sponsoring clinical trial NCT00444353?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00444353's enrollment target sits among peer trials
240 1273rd of 2000 higher than 710 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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