A Prospective Evaluation of Infraorbital Filler Injection

Study Overview
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Brief Summary
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The goal of this clinical trial is to measure the facial volumetric changes over time in patients injected with hyaluronic acid dermal filler (Juvéderm Volbella XC) in the infraorbital (under eye) region. Participants will be injected with Juvéderm Volbella XC filler and asked to return for 3D photography at 2 weeks, 1 month, and 3 months post-injection.

Detailed Description
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Undereye or infraorbital hollowing is a result of a loss of volume causing shadowing and darkness of the infraorbital region often interpreted as a tired, stressed, and aged appearance. The goal of this clinical trial is to measure the facial volumetric changes over time in patients injected with hyaluronic acid dermal filler (Juvéderm Volbella XC) in the infraorbital (under eye) region. Participants will be injected with Juvéderm Volbella XC filler and asked to return for 3D photography and to complete a validated patient satisfaction questionnaire at 2 weeks, 1 month, and 3 months post-injection. 3D photogrammetry technology allows for high level feature enhancement and microscopic anatomical evaluation that was not previously possible and can be used to make volumetric measurements at injection sites to evaluating minimally invasive injection efficacy.

Official Title
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A Prospective Evaluation of Infraorbital Filler Injection

Conditions
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Rejuvenation, Dermal Filler

Intervention / Treatment
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* Procedure: Juvederm Volbella XC hyaluronic acid dermal filler injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female age 22 to 65 interested in filler injections to reduce undereye volume loss Exclusion Criteria: male age <22 or >65 prior undereye filler filler/neurotoxin injection within the past 12 months prior facial cosmetic surgery prior facial trauma planned dental work within next 2 weeks travel 1 week prior or 2 weeks after injection

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

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infraorbital Filler<br>Receives 1-2mL injection of approved filler in infraorbital region | Procedure: Juvederm Volbella XC hyaluronic acid dermal filler injection<br>* Infraorbital filler injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volumetric change in infraorbital treatment | 3D facial imaging to measure volumetric changes in the infraorbital region | Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction with validated the questionnaire FACE-Q | Patient Satisfaction with validated the questionnaire FACE-Q | Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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injectables, tear trough rejuvenation, aesthetic improvement