Trial Outcomes & Findings for A Prospective Evaluation of Infraorbital Filler Injection (NCT NCT05694286)
NCT ID: NCT05694286
Last Updated: 2025-01-08
Results Overview
3D facial imaging to measure volumetric changes in the infraorbital region
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Post-intervention, Day 14, Day 30, Day 90
Results posted on
2025-01-08
Participant Flow
Participant milestones
| Measure |
Infraorbital Filler
Receives 1-2mL injection of approved filler in infraorbital region
Juvederm Volbella XC hyaluronic acid dermal filler injection: Infraorbital filler injection
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective Evaluation of Infraorbital Filler Injection
Baseline characteristics by cohort
| Measure |
Infraorbital Filler
n=11 Participants
Receives 1-2mL injection of approved filler in infraorbital region
Juvederm Volbella XC hyaluronic acid dermal filler injection: Infraorbital filler injection
|
|---|---|
|
Age, Continuous
|
39.6 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
BMI
|
24.9 kg/m^2
n=99 Participants
|
PRIMARY outcome
Timeframe: Post-intervention, Day 14, Day 30, Day 903D facial imaging to measure volumetric changes in the infraorbital region
Outcome measures
| Measure |
Infraorbital Filler
n=11 Participants
Receives 1-2mL injection of approved filler in infraorbital region
Juvederm Volbella XC hyaluronic acid dermal filler injection: Infraorbital filler injection
|
|---|---|
|
Volumetric Change in Infraorbital Treatment Baseline to Each Post-intervention Timepoint Day 14, Day 30, and Day 90
Post-injection Day 14
|
-0.026 cc
Standard Deviation 0.044
|
|
Volumetric Change in Infraorbital Treatment Baseline to Each Post-intervention Timepoint Day 14, Day 30, and Day 90
Post-injection Day 30
|
-0.065 cc
Standard Deviation 0.054
|
|
Volumetric Change in Infraorbital Treatment Baseline to Each Post-intervention Timepoint Day 14, Day 30, and Day 90
Post-injection Day 90
|
-0.108 cc
Standard Deviation 0.057
|
SECONDARY outcome
Timeframe: Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90Patient Satisfaction using the validated the questionnaire FACE-Q for patient reported outcomes. Higher scores reflect a better outcome.
Outcome measures
| Measure |
Infraorbital Filler
n=11 Participants
Receives 1-2mL injection of approved filler in infraorbital region
Juvederm Volbella XC hyaluronic acid dermal filler injection: Infraorbital filler injection
|
|---|---|
|
Patient Satisfaction With Validated the Questionnaire FACE-Q
FACE-Q - Satisfaction with Eyes at Day 0 pre-injection (minimum score is 0, maximum score is 100)
|
46.4 score on a scale
Standard Deviation 9.5
|
|
Patient Satisfaction With Validated the Questionnaire FACE-Q
FACE-Q - Satisfaction with Eyes at Day 0 immediate post-injection (min score is 0, max score is 100)
|
59.9 score on a scale
Standard Deviation 14.7
|
|
Patient Satisfaction With Validated the Questionnaire FACE-Q
FACE-Q - Satisfaction with Eyes at Day 14 post-injection (minimum score is 0, maximum score is 100)
|
61.4 score on a scale
Standard Deviation 13.9
|
|
Patient Satisfaction With Validated the Questionnaire FACE-Q
FACE-Q - Satisfaction with Eyes at Day 30 post-injection (minimum score is 0, maximum score is 100)
|
66.6 score on a scale
Standard Deviation 16
|
|
Patient Satisfaction With Validated the Questionnaire FACE-Q
FACE-Q - Satisfaction with Eyes at Day 90 post-injection (minimum score is 0, maximum score is 100)
|
63.4 score on a scale
Standard Deviation 19.1
|
|
Patient Satisfaction With Validated the Questionnaire FACE-Q
FACE-Q - Appraisal of Lower eyelids at Day 0 pre-injection (minimum score is 0, max score is 100)
|
55.4 score on a scale
Standard Deviation 11.9
|
|
Patient Satisfaction With Validated the Questionnaire FACE-Q
FACE-Q - Appraisal of Lower eyelids Day 0 immediate post-injection (min score 0, max score is 100)
|
65.6 score on a scale
Standard Deviation 19.6
|
|
Patient Satisfaction With Validated the Questionnaire FACE-Q
FACE-Q - Appraisal of Lower eyelids at Day 14 post-injection (minimum score is 0, max score is 100)
|
71.1 score on a scale
Standard Deviation 13.5
|
|
Patient Satisfaction With Validated the Questionnaire FACE-Q
FACE-Q - Appraisal of Lower eyelids at Day 30 post-injection (minimum score is 0, max score is 100)
|
68.5 score on a scale
Standard Deviation 14.1
|
|
Patient Satisfaction With Validated the Questionnaire FACE-Q
FACE-Q - Appraisal of Lower eyelids at Day 90 post-injection (minimum score is 0, max score is 100)
|
66.7 score on a scale
Standard Deviation 15.2
|
|
Patient Satisfaction With Validated the Questionnaire FACE-Q
FACE-Q - Aging Appraisal at Day 0 pre-injection (minimum score is 0, maximum score is 100)
|
58.5 score on a scale
Standard Deviation 23.9
|
|
Patient Satisfaction With Validated the Questionnaire FACE-Q
FACE-Q - Aging Appraisal at Day 0 immediate post-injection (minimum score is 0, max score is 100)
|
62.5 score on a scale
Standard Deviation 25
|
|
Patient Satisfaction With Validated the Questionnaire FACE-Q
FACE-Q - Aging Appraisal at Day 14 post-injection (minimum score is 0, maximum score is 100)
|
60.1 score on a scale
Standard Deviation 22.3
|
|
Patient Satisfaction With Validated the Questionnaire FACE-Q
FACE-Q - Aging Appraisal at Day 30 post-injection (minimum score is 0, maximum score is 100)
|
62.6 score on a scale
Standard Deviation 18
|
|
Patient Satisfaction With Validated the Questionnaire FACE-Q
FACE-Q - Aging Appraisal at Day 90 post-injection (minimum score is 0, maximum score is 100)
|
64.2 score on a scale
Standard Deviation 20.6
|
Adverse Events
Infraorbital Filler
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place