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
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- AbbVie
- Study ID
- NCT06734351
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Mid Face Volume Deficit
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- NOA VOLUME — DEVICEInjections
- VOLUMA XC — DEVICEInjections
Study Details
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.
Key Dates
- Start date
- Dec 16, 2024
- Status verified
- Jun 2026
- Primary completion
- Jul 31, 2029
- Completion
- Jul 31, 2029
Study Design
- Enrollment
- 231 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1: NOA VOLUMEParticipants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18.
- Experimental: Cohort 1: VOLUMA XCParticipants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18.
- Experimental: Cohort 2: NOA VOLUMEParticipants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18.
- Experimental: Cohort 2: VOLUMA XCParticipants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18.
Primary Outcome Measure
Percentage of Participants Achieving "Responder" Status Based on the Evaluating Investigator's (EI) Live Assessment of Mid-Face Volume Deficit Scale (MFVDS) [ Time Frame: Month 6 ]
Central Contacts
- ABBVIE CALL CENTER844-663-3742