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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

NCT04927052 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2023-11-29

No results posted yet for this study

Summary

To compare the safety and efficacy profiles of Revanesse Shape + with Lidocaine versus Juvederm Voluma with Lidocaine for subcutaneous and/or supraperiosteal injection to improve appearance through the correction of age-related mid-face volume deficit in patients 22 years of age through 65 years of age.

Midface volume deficit / lipoatrophy (loss of subcutaneous adipose tissue that is most apparent in the face) may be associated with acquired conditions, the aging process, or based on genetic causes.

Conditions

  • Volume Deficit in the Mid-face

Interventions

DEVICE

Revanesse Shape + with Lidocaine

Revanesse Shape + with Lidocaine. Participants had 1 cheek treated with Revanesse Shape + with Lidocaine

DEVICE

Juvederm Voluma with Lidocaine.

Juvederm Voluma with Lidocaine. Participants had 1 cheek treated with Juvederm Voluma with Lidocaine

Sponsors & Collaborators

  • Prollenium Medical Technologies Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-21
Primary Completion
2023-08-30
Completion
2023-08-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04927052 on ClinicalTrials.gov