Dermal Filler, Rejuvenation
Conditions
Keywords
injectables, tear trough rejuvenation, aesthetic improvement
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.
Interventions
PROCEDUREJuvederm Volbella XC hyaluronic acid dermal filler injection
Infraorbital filler injection
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volumetric Change in Infraorbital Treatment Baseline to Each Post-intervention Timepoint Day 14, Day 30, and Day 90 | Post-intervention, Day 14, Day 30, Day 90 | 3D facial imaging to measure volumetric changes in the infraorbital region |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Validated the Questionnaire FACE-Q | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Infraorbital Filler Receives 1-2mL injection of approved filler in infraorbital region
Juvederm Volbella XC hyaluronic acid dermal filler injection: Infraorbital filler injection | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Infraorbital Filler |
|---|---|
| Age, Continuous | 39.6 years |
| BMI | 24.9 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
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
Time frame: Post-intervention, Day 14, Day 30, Day 90
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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
Patient Satisfaction With Validated the Questionnaire FACE-Q
Patient Satisfaction using the validated the questionnaire FACE-Q for patient reported outcomes. Higher scores reflect a better outcome.
Time frame: Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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 |
| Infraorbital Filler | 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 |