CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Belotero Balance (+) Lidocaine, needle +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04594239
NCT04594239N/ACompleted
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Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow

Merz North America, Inc.·interventional·Posted Oct 20, 2020·Updated Jan 30, 2024

In Brief

A clinical study evaluating Belotero Balance (+) Lidocaine, needle, Belotero Balance (+) Lidocaine, cannula, and 2 other interventions for Volume Loss in the Infraorbital Hollow Area. Completed, enrolled 150 participants across 9 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVolume Loss in the Infraorbital Hollow Area
CountriesPuerto Rico, United States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 20, 2020
Enrollment StartAug 31, 2020
Primary CompletionApr 8, 2021
Study CompletionJun 21, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.7 years ago

Interventions

Belotero Balance (+) Lidocaine, needledevice

Injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles

Belotero Balance (+) Lidocaine, cannuladevice

Injection of Belotero Balance (+) Lidocaine into the infraorbital hollows using cannulas

Untreated-control / delayed-treatment, needledevice

Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles)

Untreated-control / delayed-treatment, cannulasdevice

Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using cannulas)