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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2022-06-21

Brief Summary

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* 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.

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Detailed Description

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Conditions

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Volume Loss in the Infraorbital Hollow Area

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment, needle

Group Type EXPERIMENTAL

Belotero Balance (+) Lidocaine, needle

Intervention Type DEVICE

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

Treatment, cannula

Group Type EXPERIMENTAL

Belotero Balance (+) Lidocaine, cannula

Intervention Type DEVICE

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

Untreated-control / delayed-treatment, needle

Group Type OTHER

Untreated-control / delayed-treatment, needle

Intervention Type DEVICE

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, cannula

Group Type OTHER

Untreated-control / delayed-treatment, cannulas

Intervention Type DEVICE

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

Interventions

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Belotero Balance (+) Lidocaine, needle

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

Intervention Type DEVICE

Belotero Balance (+) Lidocaine, cannula

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

Intervention Type DEVICE

Untreated-control / delayed-treatment, needle

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

Intervention Type DEVICE

Untreated-control / delayed-treatment, cannulas

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Is a candidate for bilateral IOH treatment.
* Has symmetrical right and left IOHs with the same MIHAS score of 2 or 3 (moderate or severe), as assessed live by the blinded evaluator.

Exclusion Criteria

* Prior lower-eyelid surgery, including orbital or midface surgery, or a permanent implant or graft in the midfacial region that could interfere with effectiveness assessments.
* Previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the midfacial region.
* Previous lower-eyelid and/or malar-region treatments with any dermal fillers (e.g., collagen, hyaluronic acid (HA), calcium hydroxyapatite, poly L-lactic acid (PLLA)) within the past 24 months.
* Any other medical condition with the potential to interfere with the study outcome assessments or compromise subject safety.

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No