- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06694857
A Prospective Evaluation of the Filler for Jaw Contouring
3-Dimensional Volumetric Analysis of a Hyaluronic Filler Injection for Jaw Contouring
The goal of this prospective study is to analyze volumetric changes in the lower face after hyaluronic acid filler injections over 90 days. The main question it aims to answer is:
To quantify volume change of the lower face area over time after injection of filler
- Participants will receive hyaluronic acid filler injections (Juvéderm Volux XC) for contouring of the jawline. Each patient will receive FDA approved dosages of filler to the lower face region to treat facial contour or asymmetry, as per FDA approved indications.
- Prior to injection patients will be imaged with 3-dimensional photogrammetry. Subjects will return post-injection in 2 weeks, 1 month, and 3 months for re-imaging.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Penn Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 22-55
- Patients interested in jaw contouring
- Participants must sign the informed consent form.
Exclusion Criteria:
1Prior filler for facial contouring 2) Filler injection within the past 12 months or during duration of study 3) Prior facial cosmetic surgery (ie. facelift) 4) Prior facial trauma (ie. orbital fracture) 5) Pregnant or breastfeeding 6) Planned dental work within next 2 weeks 7) The following contraindications: patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies, gram-positive bacterial protein allergies and lidocaine allergies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Filler
HA Filler to jaw line
|
patient will receive FDA approved dosages of filler to the lower face region to treat facial contour or asymmetry, as per FDA approved indications.
Patients are limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (132 lbs) body mass per year.
Prior to injection patients will be imaged with 3-dimensional photogrammetry.
Subjects will return post-injection in 2 weeks, 1 month, and 3 months for re-imaging.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Volume change of the lower face area at 30 days post-intervention
Time Frame: 30 days
|
3D- images will be collected to determine change in volume following from pre-intervention to post-intervention (30 days)
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Volume Change of the Lower Face 14 days Post-intervention
Time Frame: 14 days
|
3D- images will be collected to determine change in volume following from pre-intervention to post-intervention (14 days)
|
14 days
|
|
Volume changes of the lower face at 90 days post-intervention
Time Frame: 90 days
|
3D- images will be collected to determine change in volume following from pre-intervention to post-intervention (90 days)
|
90 days
|
|
PRO
Time Frame: 90 Days
|
Determine patient satisfaction with lower face volume changes as determined by PROs via Validated FACE-Q Aesthetics questionnaire.
Scale scores range from 0 (lowest) to 100 (highest).
|
90 Days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#855232
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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