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RECRUITING Phase 3

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 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DEVICE NOA VOLUME
  • DEVICE VOLUMA XC

Study Locations (6)

Florida

  • Hevia Cosmetic Dermatology /ID# 258165 — Coral Gables
  • Skin Research Institute LLC /ID# 258158 — Coral Gables

Alabama

  • Total Skin and Beauty Dermatology Center /ID# 258164 — Birmingham

Louisiana

  • Pure Dermatology /ID# 258168 — Metairie

Maryland

  • Aesthetic Center at Woodholme /ID# 258166 — Baltimore

Texas

  • Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 258156 — Austin

Trial Details

FieldValue
Enrollment Target 231 participants
Start Date 2024-12-16
Est. Completion 2029-07
Phase Phase 3

Sponsor

AbbVie

603 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06734351

The ClinicalTrials.gov registry entry for NCT06734351 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 231 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Mid Face Volume Deficit appearing as the primary indexed condition, and to 2 interventions — of which NOA VOLUME is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06734351 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Florida, Alabama, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06734351 about?

NCT06734351 is a clinical study titled "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". 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...

What is the current status of trial NCT06734351?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 231 participants. The study started on 2024-12-16. Estimated completion is 2029-07.

What conditions does trial NCT06734351 study?

This clinical trial studies the following conditions: Mid Face Volume Deficit. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06734351?

The interventions under investigation include: NOA VOLUME (DEVICE), VOLUMA XC (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06734351?

This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06734351 being conducted?

This trial has 6 study locations across Alabama, Florida, Louisiana, Maryland, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial