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OpenTrials
Completed

NCT Number: NCT05694286

A Prospective Evaluation of Infraorbital Filler Injection

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.

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Key information

Conditions

Dermal Filler Rejuvenation

Age range

22 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Juvederm Volbella XC hyaluronic acid dermal filler injection

Procedure

Infraorbital filler injection

Primary outcomes

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

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

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

Secondary outcomes

  1. Patient Satisfaction With Validated the Questionnaire FACE-Q

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2023
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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