JUVÉDERM VOLUMA XC for Temporal Hollowing

No longer recruiting at 16 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Allergan

Must not be taking: Lidocaine, HA products

Disqualifiers: Autoimmune disease, Anaphylaxis, Facial surgeries, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of JUVÉDERM® VOLUMA® XC injectable gel for improving temple hollowing, a condition where the temples appear sunken. The study includes two groups: one receives the gel treatment immediately, while the other waits three months before possibly receiving the gel. Individuals in good health who notice sunken temples and wish to explore this gel as a solution are suitable candidates for the trial. As a Phase 3 trial, this study is the final step before FDA approval, allowing participants to contribute to the potential availability of this treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that JUVÉDERM VOLUMA® XC Injectable Gel is likely to be safe for humans?

Research has shown that JUVÉDERM VOLUMA® XC is generally safe for most people. The most common side effects occur at the injection site and are temporary. These may include tenderness, swelling, firmness, small lumps or bumps, bruising, pain, redness, discoloration, and itching. These reactions typically resolve on their own. While common, these side effects are usually not serious. The FDA has already approved this gel for other uses, indicating a known safety record. However, discussing potential risks with healthcare professionals before joining a trial is always important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JUVÉDERM® VOLUMA® XC for treating temple hollowing because it offers a unique approach compared to current options like fat grafting or surgical implants. This injectable gel is made from hyaluronic acid, a substance naturally found in the body, which helps to restore volume and smooth out the hollow areas in the temples. Unlike traditional methods, it provides a non-surgical option with potentially fewer risks and downtime, allowing for immediate volume enhancement. Additionally, the treatment’s effects can be customized and adjusted with optional touch-ups, providing flexibility in achieving desired results.

What evidence suggests that JUVÉDERM VOLUMA® XC is effective for temple hollowing?

Research shows that JUVÉDERM VOLUMA® XC Injectable Gel effectively enhances cheeks. Studies have found that this gel noticeably increases cheek volume and shape. Many patients in these studies saw visible improvements in the treated areas, suggesting it might also work for filling in temple hollows. In this trial, some participants will receive JUVÉDERM VOLUMA® XC to treat temple hollows, while others will initially receive no treatment before having the option to receive the gel. The gel adds volume under the skin, smoothing out hollow spots. While primarily used for cheeks, its mechanism suggests it could also be effective for temple hollows. ^{5 6 7 8 9}

Who Is on the Research Team?

ALLERGAN, INC.

Principal Investigator

Allergan

Are You a Good Fit for This Trial?

Inclusion Criteria

You are in general good physical and mental condition.

Participants wanting to reduce temple hollowing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

Participants received no treatment or JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples

3 months

Post-Control Period

Participants received an optional touch-up treatment 30 days after the initial treatment

1 month

Maintenance Treatment Period

Participants received an optional maintenance treatment and were followed for safety and effectiveness

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JUVÉDERM VOLUMA® XC Injectable Gel

How Is the Trial Designed?

Group I: No Treatment then JUVÉDERM® VOLUMA® XC Experimental Treatment 2 Interventions

Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.

Group II: JUVÉDERM® VOLUMA® XC Experimental Treatment 1 Intervention

Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.

Who Is Running the Clinical Trial?

Allergan

Lead Sponsor

Trials

782

Recruited

277,000+

Brent Saunders

Allergan

Chief Executive Officer since 2015

JD and MBA from Temple University

Dr. David Nicholson

Allergan

Chief Medical Officer since 2015

MD from Harvard Medical School

Published Research Related to This Trial

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 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 involving 115 healthy subjects, Juvéderm® VOLUMA® with Lidocaine demonstrated high effectiveness for mid-face augmentation, with 95.6% of participants reporting satisfaction immediately after treatment and 93.7% at 21 days post-treatment.

The treatment was well tolerated, with minimal pain reported, primarily related to the injection procedure, indicating a favorable safety profile for this hyaluronic acid-based gel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, observational study of the volumizing effect of open-label aesthetic use of Juvéderm® VOLUMA® with Lidocaine in mid-face area. Philipp-Dormston, WG., Eccleston, D., De Boulle, K., et al.[2015]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf11/P110033S070B.pdf

summary of safety and effectiveness data (ssed) i. general ... Vision abnormalities have been reported following injection of JUVÉDERM®. VOLUMA®, with and without lidocaine, into the nose, glabella, periorbital area, cheek,.

2. cochranelibrary.com cochranelibrary.com/content?templateType=related&urlTitle=/central/doi/10.1002/central/CN-02029579&doi=10.1002/central/CN-02029579&p_p_id=scolariscontentdisplay_WAR_scolariscontentdisplay&_scolariscontentdisplay_WAR_scolariscontentdisplay_action=related-content&p_p_lifecycle=0&p_p_mode=view&type=central&contentLanguage=

Safety and Effectiveness of Juvéderm® VOLUMA XC ... A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula. NCT03438266. https://clinicaltrials.gov ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00978042?term=NCT00978042&viewType=Table&rank=1

Safety and Effectiveness of Juvéderm® VOLUMA XC ... Multicenter, single-blind, randomized, "no-treatment" control study to demonstrate the safety and effectiveness of VOLUMA XC for deep injection for cheek ...

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

Juvederm Patient Outcomes | JUVÉDERM® Official JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such ...

5. withpower.com withpower.com/trial/phase-3-4-2020-74d3a

A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable ... This trial is testing a cosmetic filler called Juvederm® Voluma® XC on adults who want to fill in hollow areas in their temples. The filler works by adding ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf11/p110033d.pdf

About JUVÉDERM VOLUMA XC Contents The most common side effects include temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, ...

7. drtyrone.com drtyrone.com/content/uploads/pdfs/juvederm.pdf

JUVÉDERM® XC Indication and Important Safety Information The most common side effects include tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. With JUVÉDERM® XC and ...

8. kushnerdermatology.com kushnerdermatology.com/service/voluma-safety/

VOLUMA® Safety - Dr. Rachel R. ... Side effects in > 5% of subjects were temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.

9. rxlist.com rxlist.com/juvandeacutederm-voluma-xc-drug.htm

Juvéderm Voluma XC (Hyaluronic Acid Injectable Gel ... What Are Side Effects of Juvederm Voluma XC? · tenderness, · swelling, · firmness, · lumps/bumps, · bruising, pain, · redness, · discoloration, and · itching ...