A Prospective Evaluation of Infraorbital Filler Injection
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Volumetric Change in Infraorbital Treatment Baseline to Each Post-intervention Timepoint Day 14, Day 30, and Day 90
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age 22 to 65
- •interested in filler injections to reduce undereye volume loss
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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
- Patient Satisfaction With Validated the Questionnaire FACE-Q(Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90)
Investigators
Ivona Percec
Principal Investigator
University of Pennsylvania