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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of hyaluronic acid filler in shaping the jawline. Participants will receive injections in their lower face and visit the clinic to track changes over 90 days. The trial is designed for individuals seeking jaw contouring who have not previously undergone facial fillers or surgery. Photographs will measure changes after receiving the filler. As a Phase 4 trial, this research helps determine how this FDA-approved and proven effective treatment benefits a broader range of patients.

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 is the safety track record for Juvéderm Volux XC?

A previous study found Juvéderm Volux XC to be safe for enhancing the jawline. Research shows that most people tolerate this hyaluronic acid filler well. The study included 156 participants and found that the benefits of improving jawline definition outweighed the risks.

The FDA has approved this filler for adults over 21. While side effects can occur, they are usually mild, such as swelling or tenderness at the injection site, and typically resolve on their own. Overall, current data considers Juvéderm Volux XC safe for jawline enhancement. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike traditional jaw contouring options like surgical implants or other fillers, Juvéderm Volux XC uses hyaluronic acid (HA) specifically designed for the jawline. This HA filler is unique because it provides a non-surgical, minimally invasive alternative, offering a more natural look and feel. Researchers are excited because it allows for precise sculpting with immediate results and minimal downtime, appealing to those seeking a quick, effective enhancement.

What is the effectiveness track record for Juvéderm Volux XC in jaw contouring?

Research has shown that Juvéderm Volux XC, the treatment under study in this trial, effectively improves jawline definition. Studies have found that it noticeably enhances the shape and balance of the jaw. Users report greater satisfaction with their appearance after treatment. The FDA has approved this filler specifically for the jawline and chin, supporting its effectiveness. Overall, patients have reported high satisfaction with the results, highlighting its success in achieving the desired look. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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 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]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf11/P110033S065B.pdf

FDA - summary of safety and effectiveness data (sSED) The results of the V25L-002 study demonstrate the effectiveness of JUVÉDERM® VOLUX™ XC for improvement in jawline definition. The predefined ...

2. hcp.juvederm.com hcp.juvederm.com/patient-outcomes

Juvederm Patient Outcomes | JUVÉDERM® Official JUVÉDERM® VOLUX® XC injectable gel is indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7427156/

VYC-25L Hyaluronic Acid Injectable Gel Is Safe and ... Overall mean (95% CI) Satisfaction with Chin scores improved from 41.4 (95% CI: 38.6, 44.3) at baseline to 55.1 (95% CI: 51.4, 58.8) at month 18 ...

4. americanboardcosmeticsurgery.org americanboardcosmeticsurgery.org/news/new-fda-approved-juvederm-volux-dermal-filler/

Meet the New FDA-Approved Juvéderm Volux Dermal Filler Here's what we know about Juvéderm Volux, which recently became the first dermal filler approved by the FDA for use in the jawline and chin.

5. academic.oup.com academic.oup.com/asj/article/45/1/98/7733617

Hyaluronic Acid Filler VYC-25L for Jawline Restoration Yields ... Treatment with VYC-25L to improve jawline definition yielded high patient satisfaction, objective improvements in jawline profile, and comparable effectiveness ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf11/P110033S065C.pdf

JUVÉDERM® VOLUX™ XC Patient Information Labeling To establish the safety and effectiveness of JUVÉDERM® VOLUX™ XC injectable gel for improving jawline definition, 156 participants from the treatment group ...

7. asds.net asds.net/Portals/0/PDF/Resident-Kit-Allergan-JUV%C3%89DERM-VOLUX-XC-Patient-Brochure.pdf

JAW INSPIRING augmentation. The safety of JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and. JUVÉDERM® VOLBELLA® XC has not been studied in patients under 22 years, and the.

8. fda.gov fda.gov/medical-devices/recently-approved-devices/juvederm-volux-xc-p110033s065

JUVÉDERM VOLUX XC – P110033/S065 JUVÉDERM VOLUX XC is indicated for use in adults over the age of 21 with moderate to severe loss of jawline definition. What will it accomplish?

9. juvederm.com juvederm.com/treatment-areas/jawline-filler

Juvederm for Jawline | JUVÉDERM® Official JUVÉDERM® VOLUX® XC is the first and only FDA approved HA filler for improving moderate to severe loss of definition in the jawline.