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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

Study Summary

This trial will compare the safety and efficacy of two different injectable treatments for midface volume deficit in adults 22-65 years of age.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline to Visit 6/Month 6 in the Medicis Mid-face Volume Scale (MMVS) score
Secondary outcome measures
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 outcome measures
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participants in this study?

"Affirmative. According to clinicaltrials.gov, this research study is actively recruiting participants and was initially posted on April 21st 2021. The trial requires 140 enrollees from 7 different sites with the most recent update occurring on June 9th 2022."

Answered by AI

How many venues are currently conducting this experiment?

"Currently, 7 medical centres are running this trial. These sites span from Westmount to Woodbridge and Laval as well as other cities. Selecting the most nearby location is recommended in order to reduce commuting needs if you decide to join this study."

Answered by AI

What is the total capacity for participants in this trial?

"Indeed, clinicaltrials.gov data confirm that this medical investigation is currently seeking volunteers. This experiment was initially advertised on April 21st 2021 and the most recent update was shared on June 9th 2022. Altogether, 140 participants are needed to be recruited from 7 distinct healthcare locations."

Answered by AI

Could I fulfill the requirements to be a participant in this experiment?

"For this trial, 140 individuals aged from 22 to 65 with mid-face volume deficits (MMVS score 3 or 4) are being recruited. To qualify, candidates must meet the following criteria: demonstrate a negative urine pregnancy test if applicable; not receive any other facial treatments that may affect their deficit during the study period; understand and comply with requirements of the study; be male or non-pregnant/non-breastfeeding women."

Answered by AI

Is the age eligibility criteria for this medical trial limited to those aged sixty or younger?

"This research effort is looking for participants over the age of 22 and under 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of Revanesse Shape + With Lidocaine Versus Juvederm Voluma With Lidocaine for the Correction of Age-Related Midface Volume Deficit / Lipoatrophy at 6 and 12 Months Post-treatment
2021. "A Study to Evaluate the Safety and Efficacy of Revanesse Shape + With Lidocaine Versus Juvederm Voluma With Lidocaine for the Correction of Age-Related Midface Volume Deficit / Lipoatrophy at 6 and 12 Months Post-treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04927052.
~34 spots leftby Apr 2025
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