A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old

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

205 Participants Needed

Trial Summary

What is the purpose of this trial?

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 volume and smoothness to the skin.

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.

What data supports the effectiveness of the treatment JUVÉDERM VOLUMA® XC Injectable Gel?

Research on similar treatments, like hyaluronic acid injections, shows they can effectively reduce pain and improve function in conditions like osteoarthritis, suggesting potential benefits for other uses. ^{1 2 3 4 5}

Is Juvéderm Voluma XC safe for use in humans?

Juvéderm Voluma XC, a hyaluronic acid gel, is approved in the United States for correcting age-related volume loss in the midface region in adults, indicating it has been evaluated for safety in humans. ^{6 7 8 9 10}

How is JUVÉDERM VOLUMA® XC different from other treatments for midface volume deficit?

JUVÉDERM VOLUMA® XC is unique because it uses a special technology called Vycross, which combines different weights of hyaluronic acid (a substance that helps keep skin plump) to provide longer-lasting results for midface volume loss compared to other fillers. ^{6 7 11 12 13}

Research Team

ALLERGAN, INC.

Principal Investigator

Allergan

Eligibility Criteria

Inclusion Criteria

You are in general good physical and mental condition.

Participants wanting to reduce temple hollowing.

Timeline

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

Treatment Details

Interventions

• JUVÉDERM VOLUMA® XC Injectable Gel

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

A prospective, randomized, double-blind, placebo controlled study to evaluate the efficacy of intraarticular hyaluronic acid for osteoarthritis of the knee. [2016]

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

Hyaluronan derivative HYMOVIS® increases cartilage volume and type ii collagen turnover in osteoarhritic knee: data from MOKHA study. [2023]

3. Poland pubmed.ncbi.nlm.nih.gov

Assessment of Synvisc treatment in osteoarthritis. [2007]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Assessment of the Response Profile to Hyaluronic Acid Plus Sorbitol Injection in Patients with Knee Osteoarthritis: Post-Hoc Analysis of a 6-Month Randomized Controlled Trial. [2022]

5. France pubmed.ncbi.nlm.nih.gov

[Efficacy and tolerability of highly crosslinked hyaluronic acid injections in the management of the enophthalmous orbit]. [2019]

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

Duration of effect by injection volume and facial subregion for a volumizing hyaluronic acid filler in treating midface volume deficit. [2022]

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

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

8. 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]

9. England 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. [2015]

10. New Zealand pubmed.ncbi.nlm.nih.gov

VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of VYC-17.5L for Long-Term Correction of Nasolabial Folds. [2022]

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

Safety and Effectiveness of the Hyaluronic Acid Dermal Filler VYC-17.5L for Nasolabial Folds: Results of a Randomized, Controlled Study. [2022]

13. 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]