A Prospective Evaluation of the Filler for Jaw Contouring

NCT06694857 | Completed Phase 4 FDA Drug

• 1 other identifier: IRB#855232
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

Jaw; Hyaluronic Acid; HA Filler; Hyaluronic Acid Filler; Filler; Cosmetic; Face; Dermal Fillers; Chin

Outcome Measures

Primary Outcomes (1)

• 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)

  30 days

Secondary Outcomes (3)

• PRO

  90 Days

• Volume Change of the Lower Face 14 days Post-intervention

  14 days

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

  90 days

Study Arms (1)

Filler

EXPERIMENTAL

HA Filler to jaw line

Drug: HA filler

Interventions

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.

Filler

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 22-55
• Patients interested in jaw contouring
• Participants must sign the informed consent form.

You may not qualify if:

• Prior 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Facies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Cosmetic Surgery

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: October 31, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)