A Prospective Evaluation of Infraorbital Filler Injection

University of Pennsylvania11 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dermal Filler Rejuvenation

Interventions

Juvederm Volbella XC hyaluronic acid dermal filler injectionPROCEDURE

Infraorbital filler injection

Eligibility

Sex: FEMALEMin age: 22 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Penn Medicine

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Volumetric Change in Infraorbital Treatment Baseline to Each Post-intervention Timepoint Day 14, Day 30, and Day 90

3D facial imaging to measure volumetric changes in the infraorbital region

Time frame: Post-intervention, Day 14, Day 30, Day 90

Secondary Outcomes

Patient Satisfaction With Validated the Questionnaire FACE-Q

Patient Satisfaction using the validated the questionnaire FACE-Q for patient reported outcomes. Higher scores reflect a better outcome.

Time frame: Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90

Data from ClinicalTrials.gov

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