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Dermal Filler

Belotero Balance (+) Lidocaine, needle for Sunken Eye

N/A
Waitlist Available
Research Sponsored by Merz North America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up bbl treatment (needle and cannula): up to 80 weeks; control/delayed-treatment bbl (needle and cannula): up to 56 weeks
Awards & highlights

Study Summary

This study is evaluating whether a lidocaine injection can help reduce the volume loss in the infraorbital hollow area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~bbl treatment (needle and cannula): up to 80 weeks; control/delayed-treatment bbl (needle and cannula): up to 56 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and bbl treatment (needle and cannula): up to 80 weeks; control/delayed-treatment bbl (needle and cannula): up to 56 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Responder Rate Based on Merz Infraorbital Hollow Assessment Scale (MIHAS) at Week 8
Secondary outcome measures
Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes at Week 8
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Related to BBL
Number of Subjects With Treatment-Emergent Serious Adverse Events (TESAEs) Related to BBL
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Untreated-control / delayed-treatment, needleExperimental Treatment1 Intervention
Group II: Untreated-control / delayed-treatment, cannulaExperimental Treatment1 Intervention
Group III: Treatment, needleExperimental Treatment1 Intervention
Group IV: Treatment, cannulaExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belotero Balance (+) Lidocaine, needle
2020
N/A
~150
Belotero Balance (+) Lidocaine, cannula
2020
N/A
~150
Untreated-control / delayed-treatment, cannulas
2020
N/A
~150
Untreated-control / delayed-treatment, needle
2020
N/A
~150

Find a Location

Who is running the clinical trial?

Merz North America, Inc.Lead Sponsor
63 Previous Clinical Trials
8,652 Total Patients Enrolled
Merz Medical ExpertStudy DirectorMerz North America, Inc.
38 Previous Clinical Trials
6,957 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow
2020. "Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04594239.
~33 spots leftby Apr 2025
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