A Prospective Evaluation of Infraorbital Filler Injection

NCT05694286 | Completed Results

• 1 other identifier: 852212
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermal Filler; Rejuvenation

Keywords

injectables; tear trough rejuvenation; aesthetic improvement

Outcome Measures

Primary Outcomes (1)

• 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

  Post-intervention, Day 14, Day 30, Day 90

Secondary Outcomes (1)

• Patient Satisfaction With Validated the Questionnaire FACE-Q

  Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90

Study Arms (1)

Infraorbital Filler

EXPERIMENTAL

Receives 1-2mL injection of approved filler in infraorbital region

Procedure: Juvederm Volbella XC hyaluronic acid dermal filler injection

Interventions

Juvederm Volbella XC hyaluronic acid dermal filler injection PROCEDURE

Infraorbital filler injection

Infraorbital Filler

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female
• age 22 to 65
• interested in filler injections to reduce undereye volume loss

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Results Point of Contact

• Title: Ivona Percec, MD, PhD
• Organization: University of Pennsylvania

ivona.percec@pennmedicine.upenn.edu

215-662-7300

Study Officials

• Ivona Percec, MD, PhD

  Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 23, 2023
• Study Start: January 6, 2023
• Primary Completion: April 29, 2023
• Study Completion: June 29, 2023
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)