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NCT01012661 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler
A Phase 4 study of Nasolabial Folds, sponsored by Merz North America.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT01012661: Completed Phase 4 study of Nasolabial Folds, sponsored by Merz North America.
NCT01012661 is a Phase 4 study of Nasolabial Folds that has completed, run by Merz North America. The registered enrollment target is 50 participants, roughly in line with the 54-participant average among 4 other Nasolabial Folds trials with a reported enrollment target. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01012661, a Phase 4 study of Nasolabial Folds, has completed, sponsored by Merz North America.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 2
- Study locations
Study Summary
To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler mixed with lidocaine.
Primary Outcome
Assessment of difference in pain score in the Radiesse Dermal Filler Mixed with Lidocaine nasolabial fold v. the Radiesse Dermal Filler without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (1 = no pain, 10 = very severe pain).
Conditions Studied
Interventions
- DEVICE Radiesse® Injectable Dermal Filler Mixed with Lidocaine
- DEVICE Radiesse® Injectable Dermal Filler without Lidocaine
Study Locations (2)
Maryland
- - Rockville
New York
- - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2008-09 |
| Est. Completion | 2009-01 |
| Phase | Phase 4 |
What the finished NCT01012661 record still lists
NCT01012661 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, roughly in line with the 54-participant average among 4 other Nasolabial Folds trials with a reported enrollment target.
The record links to 1 condition, with Nasolabial Folds appearing as the primary indexed condition, and to 2 interventions - of which Radiesse® Injectable Dermal Filler Mixed with Lidocaine is the first listed.
NCT01012661 reports a single indexed study location in Maryland, New York.
Frequently Asked Questions
What is clinical trial NCT01012661 about?
NCT01012661 is a clinical study titled "Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler". To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler mixed with lidocaine.
What is the current status of trial NCT01012661?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2008-09. Estimated completion is 2009-01.
What conditions does trial NCT01012661 study?
This clinical trial studies the following conditions: Nasolabial Folds.
What interventions are being tested in trial NCT01012661?
The interventions under investigation include: Radiesse® Injectable Dermal Filler Mixed with Lidocaine (DEVICE), Radiesse® Injectable Dermal Filler without Lidocaine (DEVICE).
Who is sponsoring clinical trial NCT01012661?
This trial is sponsored by Merz North America, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01012661 being conducted?
This trial has 2 study locations across Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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