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NCT00876265 · ClinicalTrials.gov registry record · Phase 3
Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®.
A Phase 3 study, sponsored by Merz North America.
- Completed
- Registry status
- Phase 3
- Development phase
- 118
- Enrollment target
NCT00876265: Completed Phase 3 study, sponsored by Merz North America.
NCT00876265 is a Phase 3 study that has completed, run by Merz North America. The registered enrollment target is 118 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00876265, a Phase 3 study, has completed, sponsored by Merz North America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 118 participants
- Enrollment target
Study Summary
This was a study to find out how an investigational product, Belotero, compares to a second product in people with facial wrinkles, such as nasolabial folds. Nasolabial folds are wrinkles on the face that go from the outside of the nostrils to the edges of the mouth. Additionally, this study determined Belotero is safe and tolerable and corrects facial wrinkles, such as nasolabial folds.
Primary Outcome
The severity of the nasolabial folds was measured using the wrinkle Severity Rating Scale (SRS), where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Extreme, which is an ordinal scale.
Interventions
- DEVICE Belotero
- DEVICE Zyplast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2006-12 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
What the finished NCT00876265 record still lists
NCT00876265 is an interventional study that assigns participants to a tested intervention. The registered 118 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 (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Belotero is the first listed.
NCT00876265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00876265 about?
NCT00876265 is a clinical study titled "Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®.". This was a study to find out how an investigational product, Belotero, compares to a second product in people with facial wrinkles, such as nasolabial folds. Nasolabial folds are wrinkles on the face that go from the outside of the nostrils to the edges of the mouth. Additionally, this study determi...
What is the current status of trial NCT00876265?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2006-12. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00876265?
The interventions under investigation include: Belotero (DEVICE), Zyplast (DEVICE).
Who is sponsoring clinical trial NCT00876265?
This trial is sponsored by Merz North America, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00876265's enrollment target sits among peer trials
118 1641st of 2000 higher than 359 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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