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NCT01635855 · ClinicalTrials.gov registry record · Phase 4
Belotero Post Approval Study
A Phase 4 study, sponsored by Merz North America.
- Completed
- Registry status
- Phase 4
- Development phase
- 117
- Enrollment target
NCT01635855: Completed Phase 4 study, sponsored by Merz North America.
NCT01635855 is a Phase 4 study that has completed, run by Merz North America. The registered enrollment target is 117 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01635855, a Phase 4 study, has completed, sponsored by Merz North America.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 117 participants
- Enrollment target
Study Summary
A prospective, open-label 1-month post-approval study to evaluate the short term safety of Belotero® Balance in the re-treatment of nasolabial folds.
Primary Outcome
The purpose of this study was to determine if the rate of "Severe" common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in the Belotero® Balance IDE clinical trial and Belotero® Balance Fitzpatrick Skin Type IV-VI Study (Pre-Approval Studies)."Common" is defined as pre-specified adverse events occurring in \>= 5% of study subjects. These averse events are: bruising, itching, pain, redness, swelling, discoloration, nodule, and induration.
Interventions
- DEVICE Belotero®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2012-06 |
| Est. Completion | 2012-11 |
| Phase | Phase 4 |
What the finished NCT01635855 record still lists
NCT01635855 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Belotero® is the first listed.
NCT01635855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01635855 about?
NCT01635855 is a clinical study titled "Belotero Post Approval Study". A prospective, open-label 1-month post-approval study to evaluate the short term safety of Belotero® Balance in the re-treatment of nasolabial folds.
What is the current status of trial NCT01635855?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 117 participants. The study started on 2012-06. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01635855?
The interventions under investigation include: Belotero® (DEVICE).
Who is sponsoring clinical trial NCT01635855?
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 NCT01635855's enrollment target sits among peer trials
117 714th of 2000 higher than 1,287 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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