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

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments, Revanesse Shape + with Lidocaine and Juvederm Voluma with Lidocaine, to determine which more effectively improves facial appearance by restoring volume to areas that have lost fullness due to aging or other factors. The researchers aim to understand the safety and effectiveness of these treatments when injected under the skin to fill out the mid-face area. Individuals with noticeable hollowing or loss of fullness in their cheeks who seek improvement might be suitable for the trial.

As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance facial rejuvenation options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both Revanesse Shape + with Lidocaine and Juvederm Voluma with Lidocaine are generally well-tolerated for treating volume loss in the mid-face area. Juvederm Voluma is effective and popular among patients, with results lasting up to two years. Some vision issues have been reported when Juvederm is injected in areas like the nose or around the eyes, but these concerns are less relevant for mid-face treatments.

For Revanesse Shape +, specific information is limited, but similar hyaluronic acid products (a substance naturally found in the body) have proven safe and effective. The lidocaine in both products reduces discomfort during injections. These treatments have approval for cosmetic use, indicating a strong safety record, especially when performed by trained professionals. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Revanesse Shape + with Lidocaine and Juvederm Voluma with Lidocaine because they offer promising options for addressing mid-face volume deficit, a common concern in aesthetic treatments. Both treatments use stabilized hyaluronic acid, a naturally occurring substance in the body, combined with lidocaine to minimize discomfort during injection. What sets Revanesse Shape + apart is its slightly higher concentration of hyaluronic acid (25 mg/mL compared to Juvederm Voluma's 20 mg/mL), which may provide more robust volume restoration. Additionally, these treatments are designed to deliver immediate results, unlike some treatments that can take weeks to show effects, making them a convenient and effective choice for enhancing facial volume and contour.

What evidence suggests that this trial's treatments could be effective for mid-face volume deficit?

Research has shown that Juvederm Voluma with Lidocaine, one of the treatments in this trial, effectively restores volume in the middle of the face, with results lasting up to two years. Users of this treatment report high satisfaction and few side effects. Similarly, studies have shown that Revanesse Shape + with Lidocaine, another treatment option in this trial, improves mid-face volume. This dermal filler, made with stabilized hyaluronic acid, adds volume and reduces wrinkles, while lidocaine numbs the area. Both treatments in this trial aim to enhance facial appearance by filling in lost volume due to aging or other factors. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Juvederm Voluma with Lidocaine
• Revanesse Shape + with Lidocaine

How Is the Trial Designed?

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+

Published Research Related to This Trial

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4482214/

Patient-Reported Outcomes at 2 Years Juvéderm Voluma XC for age-related MVD is effective and well-tolerated from the patient perspective, with results lasting up to 2 years.

2. 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,.

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

Juvederm Patient Outcomes | JUVÉDERM® Official APPROVED USES JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss, for augmentation of the chin ...

4. 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 ...

5. 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 ... JUVÉDERM VOLUMA XC for Change of Mid-Face ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf11/P110033b.pdf

IDE REVIEW MEMORANDUM - accessdata.fda.gov Australian Clinical Study: An open label study was conducted in Australia to evaluate the safety and effectiveness of JUVÉDERM VOLUMA™ (without lidocaine) in ...