A Prospective Evaluation of Infraorbital Filler Injection

Not Applicable

Completed

• Conditions: Rejuvenation; Dermal Filler
• Interventions: Procedure: Juvederm Volbella XC hyaluronic acid dermal filler injection

• Registration Number: NCT05694286
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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 Timeline

• Study Start: 2023-01-06
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-23
• Primary Completion: 2023-04-29
• Study Completion: 2023-06-29
• Status Verified: 2024-05
• Results First Submitted: 2024-05-07
• Results First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Results First Posted: 2025-01-08
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infraorbital Filler	Juvederm Volbella XC hyaluronic acid dermal filler injection	Receives 1-2mL injection of approved filler in infraorbital region

Primary Outcome Measures

Name	Time	Method
Volumetric Change in Infraorbital Treatment Baseline to Each Post-intervention Timepoint Day 14, Day 30, and Day 90	Post-intervention, Day 14, Day 30, Day 90	3D facial imaging to measure volumetric changes in the infraorbital region

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction With Validated the Questionnaire FACE-Q	Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90	Patient Satisfaction using the validated the questionnaire FACE-Q for patient reported outcomes. Higher scores reflect a better outcome.

Trial Locations

Locations (1)

Penn Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States