Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infraorbital Filler | Experimental | Receives 1-2mL injection of approved filler in infraorbital region |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Juvederm Volbella XC hyaluronic acid dermal filler injection | Procedure | Infraorbital filler injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ivona Percec, MD, PhD | Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Medicine | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Infraorbital Filler | Receives 1-2mL injection of approved filler in infraorbital region Juvederm Volbella XC hyaluronic acid dermal filler injection: Infraorbital filler injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Infraorbital Filler | Receives 1-2mL injection of approved filler in infraorbital region Juvederm Volbella XC hyaluronic acid dermal filler injection: Infraorbital filler injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | cc | Post-intervention, Day 14, Day 30, Day 90 |
|
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infraorbital Filler | Receives 1-2mL injection of approved filler in infraorbital region Juvederm Volbella XC hyaluronic acid dermal filler injection: Infraorbital filler injection |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ivona Percec, MD, PhD | University of Pennsylvania | 215-662-7300 | ivona.percec@pennmedicine.upenn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 21, 2022 | May 7, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90 |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
Not provided
Not provided
Not provided
|
| FACE-Q - Satisfaction with Eyes at Day 30 post-injection (minimum score is 0, maximum score is 100) |
|
| FACE-Q - Satisfaction with Eyes at Day 90 post-injection (minimum score is 0, maximum score is 100) |
|
| FACE-Q - Appraisal of Lower eyelids at Day 0 pre-injection (minimum score is 0, max score is 100) |
|
| FACE-Q - Appraisal of Lower eyelids Day 0 immediate post-injection (min score 0, max score is 100) |
|
| FACE-Q - Appraisal of Lower eyelids at Day 14 post-injection (minimum score is 0, max score is 100) |
|
| FACE-Q - Appraisal of Lower eyelids at Day 30 post-injection (minimum score is 0, max score is 100) |
|
| FACE-Q - Appraisal of Lower eyelids at Day 90 post-injection (minimum score is 0, max score is 100) |
|
| FACE-Q - Aging Appraisal at Day 0 pre-injection (minimum score is 0, maximum score is 100) |
|
| FACE-Q - Aging Appraisal at Day 0 immediate post-injection (minimum score is 0, max score is 100) |
|
| FACE-Q - Aging Appraisal at Day 14 post-injection (minimum score is 0, maximum score is 100) |
|
| FACE-Q - Aging Appraisal at Day 30 post-injection (minimum score is 0, maximum score is 100) |
|
| FACE-Q - Aging Appraisal at Day 90 post-injection (minimum score is 0, maximum score is 100) |
|