A Prospective Evaluation of the Filler for Jaw Contouring

NCT ID: NCT06694857

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-11-01

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.

Conditions

Dermal Fillers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Filler

HA Filler to jaw line

Group Type: EXPERIMENTAL

HA filler

Intervention Type: 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.

Interventions

HA filler

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Ivona Percec

Associate Director, Cosmetic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Penn Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

IRB#855232

Identifier Type: -

Identifier Source: org_study_id