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NCT04594239 · ClinicalTrials.gov registry record · NA
Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow
A NA study of Volume Loss in the Infraorbital Hollow Area, sponsored by Merz North America.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 9
- Study locations
NCT04594239 is a NA study of Volume Loss in the Infraorbital Hollow Area that has completed, run by Merz North America. The registered enrollment target is 150 participants. The trial reports 9 study locations across 6 states.
The verdict
NCT04594239, a NA study of Volume Loss in the Infraorbital Hollow Area, has completed, sponsored by Merz North America.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 9
- Study locations
Study Summary
* Confirm the effectiveness of Belotero Balance® (+) Lidocaine (BBL) injection for the correction of volume loss in the infraorbital hollow (IOH) area by demonstrating superiority to untreated control. * Confirm the safety of BBL injection for the correction of volume loss in the IOH area.
Conditions Studied
Interventions
- DEVICE Belotero Balance (+) Lidocaine, needle
- DEVICE Belotero Balance (+) Lidocaine, cannula
- DEVICE Untreated-control / delayed-treatment, needle
- DEVICE Untreated-control / delayed-treatment, cannulas
Study Locations (9)
New York
- Project Glammers, Merz Investigational Site #0010443 - Brooklyn
- The Center for Dermatology, Cosmetic & Laser Surgery, Merz Investigational Site #0010442 - Mount Kisco
- Mariwalla Dermatology, Merz Investigational Site #0010445 - West Islip
California
- Art of Skin MD, Merz Investigational Site #0010444 - Solana Beach
- Moradi MD Face Beautiful Inc., Merz Investigational Site #0010358 - Vista
Georgia
- MetroDerm / Atlanta Center for Clinical Research, Merz Investigational Site #0010446 - Atlanta
North Carolina
- HKB Surgeons, Merz Investigational Site #0010447 - Huntersville
Tennessee
- Nashville Centre for Laser & Facial Surgery, Merz Investigational Site #0010353 - Nashville
Other
- Jose Raul Montes Eyes and Facial Rejuvenation, Merz Investigational Site #0010436 - San Juan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-08-31 |
| Est. Completion | 2022-06-21 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04594239
The ClinicalTrials.gov registry entry for NCT04594239 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merz North America, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Volume Loss in the Infraorbital Hollow Area appearing as the primary indexed condition, and to 4 interventions - of which Belotero Balance (+) Lidocaine, needle is the first listed.
NCT04594239 reports 9 study locations spanning 6 distinct geographic areas - top geographies include New York, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04594239 about?
NCT04594239 is a clinical study titled "Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow". * Confirm the effectiveness of Belotero Balance® (+) Lidocaine (BBL) injection for the correction of volume loss in the infraorbital hollow (IOH) area by demonstrating superiority to untreated control. * Confirm the safety of BBL injection for the correction of volume loss in the IOH area.
What is the current status of trial NCT04594239?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2020-08-31. Estimated completion is 2022-06-21.
What conditions does trial NCT04594239 study?
This clinical trial studies the following conditions: Volume Loss in the Infraorbital Hollow Area.
What interventions are being tested in trial NCT04594239?
The interventions under investigation include: Belotero Balance (+) Lidocaine, needle (DEVICE), Belotero Balance (+) Lidocaine, cannula (DEVICE), Untreated-control / delayed-treatment, needle (DEVICE), Untreated-control / delayed-treatment, cannulas (DEVICE).
Who is sponsoring clinical trial NCT04594239?
This trial is sponsored by Merz North America, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04594239 being conducted?
This trial has 9 study locations across California, Georgia, New York, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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