Dermal FillerNCT05694286
A Prospective Evaluation of Infraorbital Filler Injection
A study testing Juvederm Volbella XC hyaluronic acid dermal filler injection in people with Dermal Filler and Rejuvenation, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dermal Filler, Rejuvenation
- What is being tested?
- Juvederm Volbella XC hyaluronic acid dermal filler injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2023to 29 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female
- age 22 to 65
- interested in filler injections to reduce undereye volume loss
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dermal Filler, Rejuvenation
- Being tested
- Juvederm Volbella XC hyaluronic acid dermal filler injection
- Keywords
- injectables, tear trough rejuvenation, aesthetic improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juvederm Volbella XC hyaluronic acid dermal filler injectionProcedure or surgery
Infraorbital filler injection
| Study group | Role | What they receive |
|---|---|---|
| Infraorbital Filler | Experimental | Receives 1-2mL injection of approved filler in infraorbital region Receives: Procedure: Juvederm Volbella XC hyaluronic acid dermal filler injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Post-intervention, Day 14, Day 30, Day 90
Secondary outcomes (1)
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.
Measured: Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start6 Jan 2023
- Primary completion29 Apr 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermal FillerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivona Percec, University of Pennsylvania
- Investigators
- Ivona Percec, MD, PhD, Principal investigator, Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694286
- Sponsor's protocol ID
- 852212
- Status last verified
- May 2024
- First submitted
- 11 Jan 2023
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Infraorbital Filler Injection
- ClinicalTrials.gov ID
- NCT05694286
- Acronym / sponsor ID
- 852212
- Conditions
- Dermal Filler, Rejuvenation
- Keywords
- injectables, tear trough rejuvenation, aesthetic improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 29 Apr 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Posted 8 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infraorbital Filler | Experimental | Procedure: Juvederm Volbella XC hyaluronic acid dermal filler injectionReceives 1-2mL injection of approved filler in infraorbital region |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female
- age 22 to 65
- interested in filler injections to reduce undereye volume loss
Key exclusion criteria (8 listed)
- male
- age <22 or >65
- prior undereye filler
- filler/neurotoxin injection within the past 12 months
- prior facial cosmetic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Juvederm Volbella XC hyaluronic acid dermal filler injectionInfraorbital filler injection | Procedure or surgery | Infraorbital Filler |
Primary outcome
Volumetric Change in Infraorbital Treatment Baseline to Each Post-intervention Timepoint Day 14, Day 30, and Day 90
Time frame: Post-intervention, Day 14, Day 30, Day 90
3D facial imaging to measure volumetric changes in the infraorbital region
1 secondary outcome
Patient Satisfaction With Validated the Questionnaire FACE-Q
Time frame: Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivona Percec, MD, PhD principal investigator
Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juvederm Volbella XC hyaluronic acid dermal filler injection in people with Dermal Filler and Rejuvenation, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric Change in Infraorbital Treatment Baseline to Each Post-intervention Timepoint Day 14, Day 30, and Day 90 (time frame: Post-intervention, Day 14, Day 30, Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.