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A Study to Evaluate Safety and Effectiveness of NOA VOLUME Injectable Gel in Adult Participants Compared to JUVÉDERM VOLUMA XC for Improvement of Mid-Face Volume

NCT06734351 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2026-05-13

No results posted yet for this study

Summary

Facial fullness is often regarded as a characteristic feature of a youthful face. Chronic reduction of collagen, elastin, and glycosaminoglycans contribute to the facial volume loss that characterizes the aging face. Volume restoration by replacing or augmenting soft tissue is critical to successful facial rejuvenation. NOA VOLUME is a crosslinked Hyaluronic Acid (HA) injectable gel formulated with lidocaine that was developed to provide a safe, minimally invasive method of improving mid-face volume deficit. The purpose of this study is to assess safety and effectiveness of NOA VOLUME in adult participants seeking improvement of mid-face volume compared to JUVÉDERM VOLUMA XC (VOLUMA XC).

NOA VOLUME is an investigational device being developed for the improvement of mid-face volume. There will be 2 cohorts in this study. Participants will receive either NOA VOLUME or VOLUMA XC. Around 231 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 15 sites in the United States.

Participants will receive either NOA VOLUME or VOLUMA XC injections in the cheek area on Day 1. Participants will receive optional touch-up treatment at Day 31 and optional repeat treatment at Month 18 and will be followed up for up to 31 months.

Conditions

  • Mid Face Volume Deficit

Interventions

DEVICE

NOA VOLUME

Injections

DEVICE

VOLUMA XC

Injections

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-16
Primary Completion
2029-07-31
Completion
2029-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT06734351 on ClinicalTrials.gov