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Dermal Filler

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

N/A
Waitlist Available
Research Sponsored by Prollenium Medical Technologies Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2/week 2, visit 3/month 1, visit 4/month 2, visit 5/month 3, visit 6/month 6, visit 7/month 12 and visit 8/month 15
Awards & highlights

Summary

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.

Eligible Conditions
  • Mid-face Volume Deficit

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2/week 2, visit 3/month 1, visit 4/month 2, visit 5/month 3, visit 6/month 6, visit 7/month 12 and visit 8/month 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 2/week 2, visit 3/month 1, visit 4/month 2, visit 5/month 3, visit 6/month 6, visit 7/month 12 and visit 8/month 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline to Visit 6/Month 6 in the Medicis Mid-face Volume Scale (MMVS) score
Secondary study objectives
Change from baseline to Visit 7/Month 12 in the Medicis Mid-face Volume Scale (MMVS) score
Change in the Nasolabial Folds Wrinkle Severity Rating Scale score at Visit 2/Week 2, Visit 3/Month 1, Visit 4/Month 2, Visit 5/Month 3, Visit 6/Month 6, Visit 7/Month 12 and Visit 8/Month 15
Percent of subjects with clinical success at Visit 6/Month 6 where success is defined as a subject with at least a 1-grade improvement from baseline on the Investigator Global Aesthetic Improvement Score (iGAIS).
+2 more
Other study objectives
Self-perception of age for each side of the face
Subject feel of mid-face for each side of the face
Face
+6 more

Trial Design

2Treatment groups
Active Control
Group I: Revanesse Shape + with LidocaineActive Control2 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 LidocaineActive Control2 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.

Find a Location

Who is running the clinical trial?

Prollenium Medical Technologies Inc.Lead Sponsor
6 Previous Clinical Trials
581 Total Patients Enrolled

Media Library

Juvederm Voluma with Lidocaine (Dermal Filler) Clinical Trial Eligibility Overview. Trial Name: NCT04927052 — N/A
Mid-face Volume Deficit Research Study Groups: Revanesse Shape + with Lidocaine, Juvederm Voluma with Lidocaine
Mid-face Volume Deficit Clinical Trial 2023: Juvederm Voluma with Lidocaine Highlights & Side Effects. Trial Name: NCT04927052 — N/A
Juvederm Voluma with Lidocaine (Dermal Filler) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04927052 — N/A
~31 spots leftby Oct 2025