Revanesse Shape + and Juvederm Voluma for Mid-face Volume Deficit

Recruiting at 6 trial locations

Overseen By Director, Clinical Affairs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Prollenium Medical Technologies Inc.

Must not be taking: Anticoagulants, NSAIDs, Corticosteroids, Immunosuppressives

Disqualifiers: Pregnancy, Facial surgery, Skin disease, others

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

Compensation: Varies

Number of Visits: 21

Duration: 12 months

136 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two facial fillers, Revanesse Shape + and Juvederm Voluma, in adults aged 22-65 who have lost facial fat. The fillers are injected to restore volume and improve facial appearance, with lidocaine reducing injection pain. Juvederm Voluma is known for its long-lasting and natural results.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must avoid certain medications like anticoagulants, NSAIDs, and corticosteroids for specific periods before and during the study.

What data supports the effectiveness of the drug Juvederm Voluma with Lidocaine for mid-face volume deficit?

Research shows that Juvederm Voluma with Lidocaine is effective in restoring mid-face volume, with studies indicating a high rate of improvement in facial volume for up to two years. It has been shown to be safe and effective, with minimal side effects, in both short-term and long-term use. ^{1 2 3 4 5}

Is Juvéderm Voluma with Lidocaine safe for use in humans?

Juvéderm Voluma with Lidocaine, a hyaluronic acid-based gel, has been studied for its safety and effectiveness in facial volume restoration, and it is generally considered safe for use in humans. ^{1 3 4 6 7}

How is the drug Revanesse Shape + and Juvederm Voluma for mid-face volume deficit different from other treatments?

Revanesse Shape + and Juvederm Voluma are unique because they are hyaluronic acid-based fillers specifically designed to restore volume in the mid-face area, offering a non-surgical option for age-related volume loss. Juvederm Voluma with Lidocaine also provides the added benefit of reducing discomfort during the procedure due to the inclusion of lidocaine, a local anesthetic. ^{1 2 4 8 9}

Eligibility Criteria

Inclusion Criteria

If female and of childbearing potential, a negative urine pregnancy test at Baseline and agreement to use adequate contraception

Ability to understand and comply with the requirements of the study

Men and women who are not pregnant, not breastfeeding, and are between 22 and 65 years old.

Exclusion Criteria

Pregnant, lactating, or anticipating pregnancy during the study period

History of facial plastic surgery, tissue grafting, or tissue augmentation with permanent or semi-permanent dermal fillers within specified timeframes

You have mild to moderate muscle weakness on one side of your face.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Revanesse Shape + with Lidocaine on one side of the face and Juvederm Voluma with Lidocaine on the other side, with initial treatment at Visit 1 and potential touch-ups at Visit 3/Month 1 and between Visit 5/Month 3 and Visit 7/Month 12

12 months

Multiple visits including Day 1, Week 2, Month 1, Month 2, Month 3, Month 6, and Month 12

Safety and Effectiveness

Evaluations of safety and effectiveness, including MMVS scores, GAIS, and WSRS, are conducted at each visit

12 months

Evaluations at each visit from Baseline to Month 12

Extended Follow-up

Participants are monitored for long-term safety and effectiveness, with a final visit at Month 15

3 months

Visit 8 at Month 15

Treatment Details

Interventions

• Juvederm Voluma with Lidocaine
• Revanesse Shape + with Lidocaine

Participant Groups

Group I: Revanesse Shape + with Lidocaine Active Control 2 Interventions

Revanesse Shape + with Lidocaine is a clear, colorless gel in 1.2 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w. Participants had 1 cheek treated with Revanesse Shape + with Lidocaine

Group II: Juvederm Voluma with Lidocaine Active Control 2 Interventions

Juvederm Voluma with Lidocaine is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w. Participants had 1 cheek treated with Juvederm Voluma with Lidocaine.

Who Is Running the Clinical Trial?

Prollenium Medical Technologies Inc.

Lead Sponsor

Trials

7

Recruited

720+

Findings from Research

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]

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]

References

1. 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]

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

Lip and Perioral Enhancement: A 12-Month Prospective, Randomized, Controlled Study. [2016]

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

Juvéderm volbella with lidocaine for lip and perioral enhancement: a prospective, randomized, controlled trial. [2020]

4. 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]

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

A multicenter, randomized, double-blind comparison of two hyaluronic acid fillers in mid-face volume restoration in Asians: A 2-year extension study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvéderm injectable gel with and without lidocaine. [2013]

7. England pubmed.ncbi.nlm.nih.gov

A randomized, multicenter study on a flexible hyaluronic acid filler in treatment of moderate-to-severe nasolabial folds in a Chinese population. [2022]

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

HYC-24L Demonstrates Greater Effectiveness With Less Pain Than CPM-22.5 for Treatment of Perioral Lines in a Randomized Controlled Trial. [2015]

9. 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]