NCT06694857
Completed
Phase 4
3-Dimensional Volumetric Analysis of a Hyaluronic Filler Injection for Jaw Contouring
University of Pennsylvania1 site in 1 country14 target enrollmentStarted: October 31, 2024Last updated:
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Volume change of the lower face area at 30 days post-intervention
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
Filler
Experimental
HA Filler to jaw line
Intervention: HA filler (Drug)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- PRO(90 Days)
- Volume Change of the Lower Face 14 days Post-intervention(14 days)
- Volume changes of the lower face at 90 days post-intervention(90 days)
Investigators
Ivona Percec
Associate Director, Cosmetic Surgery
University of Pennsylvania
Study Sites (1)
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