A Prospective Evaluation of the Filler for Jaw Contouring
- Conditions
- Dermal Fillers
- Interventions
- Drug: HA filler
- Registration Number
- NCT06694857
- Lead Sponsor
- University of Pennsylvania
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 15
- Age 22-55
- Patients interested in jaw contouring
- Participants must sign the informed consent form.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Filler HA filler HA Filler to jaw line
- Primary Outcome Measures
Name Time Method Volume change of the lower face area at 30 days post-intervention 30 days 3D- images will be collected to determine change in volume following from pre-intervention to post-intervention (30 days)
- Secondary Outcome Measures
Name Time Method PRO 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).
Volume Change of the Lower Face 14 days Post-intervention 14 days 3D- images will be collected to determine change in volume following from pre-intervention to post-intervention (14 days)
Volume changes of the lower face at 90 days post-intervention 90 days 3D- images will be collected to determine change in volume following from pre-intervention to post-intervention (90 days)
Trial Locations
- Locations (1)
Penn Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Penn Medicine🇺🇸Philadelphia, Pennsylvania, United StatesSalman KhanContact215-662-7300salman.khan@pennmedicine.upenn.edu