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OpenTrials
Completed

NCT Number: NCT06694857

A Prospective Evaluation of the Filler 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.

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Key information

Conditions

Dermal Fillers Disease Attributes Facies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

22 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HA filler

Drug

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.

Primary outcomes

  1. 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

  1. 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).

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

3-Dimensional Volumetric Analysis of a Hyaluronic Filler Injection for Jaw Contouring

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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