A Prospective Evaluation of the Filler for Jaw Contouring

University of Pennsylvania14 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dermal Fillers

Interventions

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.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 22-55 2. Patients interested in jaw contouring 3. 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

Outcomes

Primary Outcomes

Volume change of the lower face area at 30 days post-intervention

3D- images will be collected to determine change in volume following from pre-intervention to post-intervention (30 days)

Time frame: 30 days

Secondary Outcomes

PRO

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).

Time frame: 90 Days

Volume Change of the Lower Face 14 days Post-intervention

3D- images will be collected to determine change in volume following from pre-intervention to post-intervention (14 days)

Time frame: 14 days

Volume changes of the lower face at 90 days post-intervention

3D- images will be collected to determine change in volume following from pre-intervention to post-intervention (90 days)

Time frame: 90 days