MedPath

A Prospective Evaluation of the Filler for Jaw Contouring

Phase 4
Active, not recruiting
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
FillerHA fillerHA Filler to jaw line
Primary Outcome Measures
NameTimeMethod
Volume change of the lower face area at 30 days post-intervention30 days

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

Secondary Outcome Measures
NameTimeMethod
PRO90 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-intervention14 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-intervention90 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 States
Salman Khan
Contact
215-662-7300
salman.khan@pennmedicine.upenn.edu

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