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

Study Overview
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Brief Summary
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Confirm the effectiveness of Belotero Balance® (+) Lidocaine injection for the correction of volume loss in the infraorbital hollow (IOH) area by demonstrating superiority to untreated control Identify the incidence of adverse events (AEs) and serious adverse events (SAEs)

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

Conditions
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Correction of Volume Loss in the Infraorbital Hollow Area

Intervention / Treatment
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* Device: Belotero Balance (+) Lidocaine, needle
* Device: Belotero Balance (+) Lidocaine, cannula
* Device: Untreated-control / delayed-treatment, needle
* Device: Untreated-control / delayed-treatment, cannulas


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment, needle<br> | Device: Belotero Balance (+) Lidocaine, needle<br>* Injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles<br>|
| Experimental: Treatment, cannula<br> | Device: Belotero Balance (+) Lidocaine, cannula<br>* Injection of Belotero Balance (+) Lidocaine into the infraorbital hollows using cannulas<br>|
| Other: Untreated-control / delayed-treatment, needle<br> | Device: Untreated-control / delayed-treatment, needle<br>* Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles)<br>|
| Other: Untreated-control / delayed-treatment, cannula<br> | Device: Untreated-control / delayed-treatment, cannulas<br>* Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using cannulas)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of responders at Week 8 on the Merz Infraorbital Hollow Assessment Scale (MIHAS) | The MIHAS is a 5-grade scale. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Aesthetic Improvement Scale (GAIS) score at Week 8, as assessed by the treating investigator |  | Week 8 | 
| Global Aesthetic Improvement Scale (GAIS) score at Week 8, as assessed by the subject |  | Week 8 | 
| FACE-Q™ Satisfaction with Eyes scores and changes from baseline to Week 8 |  | Baseline to Week 8 | 
| Incidence of treatment-emergent adverse events (TEAEs) related to Belotero Balance |  | From baseline to week 72-76 | 
| Incidence of treatment-emergent serious adverse events (TESAEs) related to Belotero Balance |  | From baseline to week 72-76 |