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NCT06734351 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Mid Face Volume Deficit, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 231
- Enrollment target
- 6
- Study locations
NCT06734351: Recruiting Phase 3 study of Mid Face Volume Deficit, sponsored by AbbVie.
NCT06734351 is a Phase 3 study of Mid Face Volume Deficit that is actively recruiting participants, run by AbbVie. The registered enrollment target is 231 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06734351, a Phase 3 study of Mid Face Volume Deficit, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 231 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
A "responder" is defined as a participant with at least 1-point improvement (reduction) of mid face volume deficit using the MFVDS. MFVDS is a validated 5-point scale (1 = None/Minimal to 5 = Severe).
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
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2024-12-16 |
| Est. Completion | 2029-07 |
| Phase | Phase 3 |
What NCT06734351 shows while recruiting
NCT06734351 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
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.
NCT06734351 lists 6 locations in 5 states (Florida, Alabama, Louisiana).
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.
What interventions are being tested in trial NCT06734351?
The interventions under investigation include: NOA VOLUME (DEVICE), VOLUMA XC (DEVICE).
Who is sponsoring clinical trial NCT06734351?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06734351's enrollment target sits among peer trials
231 1301st of 2000 higher than 697 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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