NCT05694286

A Prospective Evaluation of Infraorbital Filler Injection

Completed NA Results posted Last updated 8 January 2025

What this trial tests

NA trial testing Juvederm Volbella XC hyaluronic acid dermal filler injection in Dermal Filler in 11 participants. Completed in 29 June 2023.

Timeline

6 January 2023

Primary endpoint
29 April 2023

29 June 2023

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	6 January 2023
Primary completion	29 April 2023
Estimated completion	29 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Juvederm Volbella XC hyaluronic acid dermal filler injection

Conditions studied

• Dermal Filler — all drugs for Dermal Filler →
• Rejuvenation — all drugs for Rejuvenation →

Sponsor

University of Pennsylvania

Who can join

Adults 22 to 65, female only, with Dermal Filler or Rejuvenation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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

Post-injection Day 14

Group	Value	95% CI
Infraorbital Filler	-0.026	± 0.044

Post-injection Day 30

Group	Value	95% CI
Infraorbital Filler	-0.065	± 0.054

Post-injection Day 90

Group	Value	95% CI
Infraorbital Filler	-0.108	± 0.057

Patient Satisfaction With Validated the Questionnaire FACE-Q Secondary · 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.

FACE-Q - Satisfaction with Eyes at Day 0 pre-injection (minimum score is 0, maximum score is 100)

Group	Value	95% CI
Infraorbital Filler	46.4	± 9.5

FACE-Q - Satisfaction with Eyes at Day 0 immediate post-injection (min score is 0, max score is 100)

Group	Value	95% CI
Infraorbital Filler	59.9	± 14.7

FACE-Q - Satisfaction with Eyes at Day 14 post-injection (minimum score is 0, maximum score is 100)

Group	Value	95% CI
Infraorbital Filler	61.4	± 13.9

FACE-Q - Satisfaction with Eyes at Day 30 post-injection (minimum score is 0, maximum score is 100)

Group	Value	95% CI
Infraorbital Filler	66.6	± 16

FACE-Q - Satisfaction with Eyes at Day 90 post-injection (minimum score is 0, maximum score is 100)

Group	Value	95% CI
Infraorbital Filler	63.4	± 19.1

FACE-Q - Appraisal of Lower eyelids at Day 0 pre-injection (minimum score is 0, max score is 100)

Group	Value	95% CI
Infraorbital Filler	55.4	± 11.9

FACE-Q - Appraisal of Lower eyelids Day 0 immediate post-injection (min score 0, max score is 100)

Group	Value	95% CI
Infraorbital Filler	65.6	± 19.6

FACE-Q - Appraisal of Lower eyelids at Day 14 post-injection (minimum score is 0, max score is 100)

Group	Value	95% CI
Infraorbital Filler	71.1	± 13.5

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.