Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03777917 · ClinicalTrials.gov registry record · NA
A Pilot Study to Assess the Effectiveness and Safety of Belotero Balance® Injection for Volume Augmentation of the Infraorbital Hollow
A NA study of Correction of Volume Loss in the Infraorbital Hollow Area, sponsored by Merz North America.
- Completed
- Registry status
- NA
- Development phase
- 66
- Enrollment target
- 3
- Study locations
NCT03777917: Completed NA study of Correction of Volume Loss in the Infraorbital Hollow Area, sponsored by Merz North America.
NCT03777917 is a NA study of Correction of Volume Loss in the Infraorbital Hollow Area that has completed, run by Merz North America. The registered enrollment target is 66 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03777917, a NA study of Correction of Volume Loss in the Infraorbital Hollow Area, has completed, sponsored by Merz North America.
- COMPLETED
- Registry status
- NA
- Development phase
- 66 participants
- Enrollment target
- 3
- Study locations
Study Summary
The pilot study aims to define safety, effectiveness, and patient-reported outcomes for Belotero Balance® use in the infraorbital hollows.
Primary Outcome
MIHAS was a 5 point scale ranging as: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (extreme). Responder rate was defined as percentage of participants with treatment response who achieved greater than or equal to (\>=) 1 grade improvement on both IOHs on the MIHAS.
Conditions Studied
Interventions
- DEVICE Belotero Balance®
Study Locations (3)
Florida
- Center for Sight, Merz Investigational Site #0010414 - Sarasota
New York
- Private Practice, Merz Investigational Site #0010413 - New York
Tennessee
- Center for Laser and Facial Surgery, Merz Investigational Site #0010353 - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2018-12-27 |
| Est. Completion | 2020-03-11 |
| Phase | NA |
What the finished NCT03777917 record still lists
NCT03777917 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Correction of Volume Loss in the Infraorbital Hollow Area appearing as the primary indexed condition, and to 1 intervention - of which Belotero Balance® is the first listed.
NCT03777917 reports a single indexed study location in Florida, New York, Tennessee.
Frequently Asked Questions
What is clinical trial NCT03777917 about?
NCT03777917 is a clinical study titled "A Pilot Study to Assess the Effectiveness and Safety of Belotero Balance® Injection for Volume Augmentation of the Infraorbital Hollow". The pilot study aims to define safety, effectiveness, and patient-reported outcomes for Belotero Balance® use in the infraorbital hollows.
What is the current status of trial NCT03777917?
This trial is currently completed. It is a NA study. The enrollment target is 66 participants. The study started on 2018-12-27. Estimated completion is 2020-03-11.
What conditions does trial NCT03777917 study?
This clinical trial studies the following conditions: Correction of Volume Loss in the Infraorbital Hollow Area.
What interventions are being tested in trial NCT03777917?
The interventions under investigation include: Belotero Balance® (DEVICE).
Who is sponsoring clinical trial NCT03777917?
This trial is sponsored by Merz North America, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03777917 being conducted?
This trial has 3 study locations across Florida, New York, 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 NCT03777917's enrollment target sits among peer trials
66 1139th of 2000 higher than 857 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
- NCT02584244 · 66 participants · Phase 1
Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
- NCT03067051 · 66 participants · Phase 1
Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System
- NCT03754725 · 66 participants · Phase 1
Ferritin and Iron Burden in SAH sIRB
- NCT03875378 · 66 participants · Phase 2
Transdermal Estrogen in Women With Anorexia Nervosa
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