Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Volume Loss in the Infraorbital Hollow Area, sponsored by Merz North America.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Responder rate was defined as percentage of subjects with treatment response at Week 8 on MIHAS, as assessed live by a blinded evaluator. Responders were defined as subjects who achieved greater than or equal to (\>=) 1 grade improvement on both IOHs on the MIHAS. MIHAS (to assess infraorbital hollow) was a 5-point scale ranging as: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (extreme). A higher score indicated extreme signs of hollowing. This analysi
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 |
What the finished NCT04594239 record still lists
NCT04594239 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
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 lists 9 locations in 6 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04594239's enrollment target sits among peer trials
150 661st of 2000 higher than 1,299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00412594 · 150 participants · Phase 2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
- NCT01484730 · 150 participants
A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion
- NCT01985919 · 150 participants
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
- NCT02016248 · 150 participants · NA
SBRT Boost for Unfavorable Prostate Cancer'
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI