Hyaluronic Acid Filler for Jaw Contouring

Overseen By Salman Khan, Research Coordinator, BS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Pennsylvania

Disqualifiers: Prior filler, Facial surgery, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants with certain allergies are excluded, so you may want to discuss your medications and allergies with the trial team.

What data supports the effectiveness of the treatment Juvéderm Volux XC for jaw contouring?

Research shows that Juvéderm Volux XC, a type of hyaluronic acid filler, is effective for remodeling the chin and lower face, which suggests it could be beneficial for jaw contouring as well. ^{1 2 3 4 5}

Is hyaluronic acid filler safe for jaw contouring?

Hyaluronic acid fillers like Juvéderm Volux have been generally considered safe for facial volume restoration, but there have been reports of delayed adverse events and sterile abscesses in some cases. ^{1 3 5 6 7}

How is the drug Juvéderm Volux XC unique for jaw contouring?

Juvéderm Volux XC is unique because it is specifically designed as a first-in-class hyaluronic acid filler for remodeling the chin and lower face, offering a tailored approach to jaw contouring that differs from other fillers primarily used for midface volume correction. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for individuals seeking to enhance their jawline contour using hyaluronic acid filler. Participants must be suitable candidates for dermal fillers as per FDA guidelines and willing to undergo imaging before and after treatment at specified intervals.

Inclusion Criteria

Participants must sign the informed consent form.

I am interested in changing the shape of my jaw.

I am between 22 and 55 years old.

Exclusion Criteria

Prior facial trauma (i.e., orbital fracture)

Pregnant or breastfeeding

I have had facial fillers for contouring before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive hyaluronic acid filler injections for jawline contouring

1 day

1 visit (in-person)

Follow-up

Participants are monitored for volumetric changes in the lower face after filler injections

12 weeks

3 visits (in-person) at 2 weeks, 1 month, and 3 months post-injection

Treatment Details

Interventions

• Juvéderm Volux XC

Trial Overview The study tests the effects of Juvéderm Volux XC, a hyaluronic acid filler, on the volume change in the lower face area over 90 days. Patients will receive injections following FDA-approved dosages and have their results tracked through 3D photogrammetry imaging.

Participant Groups

Group I: Filler Experimental Treatment 1 Intervention

HA Filler to jaw line

Juvéderm Volux XC is already approved in United States for the following indications:

Approved in United States as Juvéderm Volux XC for:

• Improvement of jawline definition in adults with moderate to severe loss of jawline definition

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

In a study of 235 patients, Juvéderm Voluma XC significantly improved midface volume and overall facial appearance, with 92.8% of patients reporting improvement at 6 months and 79.0% at 2 years after treatment.

The treatment was well-tolerated, with most side effects like tenderness and swelling being mild to moderate and lasting less than 2 weeks, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years. Few, J., Cox, SE., Paradkar-Mitragotri, D., et al.[2022]

VYC-25L (Juvéderm Volux®) is a new hyaluronic acid filler specifically designed for chin and lower facial remodeling, with recommendations provided for its use based on expert consensus from a multidisciplinary panel.

The panel identified five patient profiles that could benefit from VYC-25L and established guidelines for administration techniques and management of potential complications, emphasizing the need for standardized procedures to achieve optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An expert consensus report on the clinical use of the Vycross® hyaluronic acid VYC-25 L filler. Segurado, MA., Urdiales-Gálvez, F., Benítez, PA., et al.[2022]

The hyaluronic acid filler VYC-20L was found to be safe and effective for chin augmentation, with a high responder rate of 91.8% when assessed live at 6 months after treatment.

Live assessments of treatment response yielded significantly higher rates of improvement compared to photographic assessments (91.8% vs. 56.3%), suggesting that live evaluations may better reflect real-world outcomes in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher Responder Rates Observed With Live Participant Assessment Versus Photo Assessment After VYC-20L Hyaluronic Acid Treatment for Chin Augmentation. Dayan, S., Green, JB., Schlesinger, T., et al.[2023]

In a study of 167 subjects with age-related midface volume deficit, repeat treatment with Juvéderm Voluma XC (VYC-20L) demonstrated high effectiveness, with 82.8% and 91.1% of subjects showing improvement at 6 and 12 months, respectively.

The safety profile improved with repeat treatments, as the incidence and severity of common treatment-site responses were lower compared to initial treatments, indicating that VYC-20L is well tolerated over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Results After Repeat Treatment. Baumann, L., Narins, RS., Beer, K., et al.[2015]

Juvéderm Volux is a safe and effective injectable treatment for chin retrusion, showing significant improvements in facial angle and high patient satisfaction over 18 months, with 52.5% of treated subjects rated as improved by investigators.

After a repeat treatment, 96.9% of subjects reported improvement, and durable satisfaction was noted in over 90% of subjects for chin and jawline aesthetics, indicating that Volux can be a long-lasting alternative to surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VYC-25L Hyaluronic Acid Injectable Gel Is Safe and Effective for Long-Term Restoration and Creation of Volume of the Lower Face. Ogilvie, P., Benouaiche, L., Philipp-Dormston, WG., et al.[2022]

In a study of 4500 patients receiving 9324 treatments with the hyaluronic acid filler Juvéderm Voluma, delayed adverse events (DAEs) occurred at a rate of 0.98% per patient, primarily manifesting as delayed swelling and nodule formation.

DAEs were generally transient and resolved without complications, with a potential link to immunologic triggers and an increase in frequency during certain months, suggesting that the degradation process of the filler may play a role in these reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective review of delayed adverse events secondary to treatment with a smooth, cohesive 20-mg/mL hyaluronic acid filler in 4500 patients. Humphrey, S., Jones, DH., Carruthers, JD., et al.[2021]

The use of Juvederm Volux®, a hyaluronic acid filler, has been associated with an increase in sterile abscesses, with five patients experiencing this adverse reaction that did not respond to standard treatments.

The 'Munhoz-Cavallieri lavage protocol' was successfully used to resolve these recalcitrant sterile abscesses, indicating a potential effective treatment for this complication following HA filler procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recalcitrant Sterile Abscesses by Volux®: A New Therapeutic Approach. Balassiano, LKA., Cunha, JMT., Munhoz, G., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years. [2022]

2. England pubmed.ncbi.nlm.nih.gov

An expert consensus report on the clinical use of the Vycross® hyaluronic acid VYC-25 L filler. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Higher Responder Rates Observed With Live Participant Assessment Versus Photo Assessment After VYC-20L Hyaluronic Acid Treatment for Chin Augmentation. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Results After Repeat Treatment. [2015]

5. England pubmed.ncbi.nlm.nih.gov

VYC-25L Hyaluronic Acid Injectable Gel Is Safe and Effective for Long-Term Restoration and Creation of Volume of the Lower Face. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Retrospective review of delayed adverse events secondary to treatment with a smooth, cohesive 20-mg/mL hyaluronic acid filler in 4500 patients. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Recalcitrant Sterile Abscesses by Volux®: A New Therapeutic Approach. [2023]