Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED NA

Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow

NCT04594239 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 150 participants
Start Date 2020-08-31
Est. Completion 2022-06-21
Phase NA

Sponsor

Merz North America

37 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04594239 reports 9 study locations spanning 6 distinct geographic areas — top geographies include New York, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04594239?

This trial is sponsored by Merz North America, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial