A Prospective Evaluation of Infraorbital Filler Injection

Dermal Filler Clinical Trial

Official title:

A Prospective Evaluation of Infraorbital Filler Injection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05694286
• Other study ID #: 852212
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 6, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermal Filler
• Rejuvenation

Intervention

Procedure:
• Juvederm Volbella XC hyaluronic acid dermal filler injection
Infraorbital filler injection

Locations

Country	Name	City	State
United States	Penn Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volumetric change in infraorbital treatment	3D facial imaging to measure volumetric changes in the infraorbital region	Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90
Secondary	Patient Satisfaction with validated the questionnaire FACE-Q	Patient Satisfaction with validated the questionnaire FACE-Q	Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90