A Study to Assess Safety and Effectiveness of Injections of NOA VOLUME Injectable Gel in Adult Participants Compared to JUVÉDERM VOLUMA XC for Change of Mid-Face Volume
Purpose
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) gel implant 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. In Cohort 1, participants will receive either NOA VOLUME or VOLUMA XC with a fixed follow-up period. In Cohort 2, participants will receive either NOA VOLUME or VOLUMA XC with a variable follow-up period. 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 as subcutaneous and/or supraperiosteal plane injections in the cheek on Day 1. Participants will receive optional touch-up treatment at Day 31 and optional repeat treatment at Month 18 for Cohort 1 and at Month 12, 15, or 18 for Cohort 2 and will be followed up for up to 22 months.
Condition
- Mid Face Volume Deficit
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Has moderate (3), significant (4), or severe (5) mid-face volume deficit on the 5-point photonumeric MFVDS based on evaluating investigator's (EI) live assessment. - Mid-face is amenable to achieving at least a 1-point improvement in MFVDS score with the allowed injection volume in the treating investigator's (TI) judgement.
Exclusion Criteria
- Significant skin laxity in the midface in the opinion of the TI. - Significant skin pigmentation disorders or discoloration in the mid-face area that would interfere with the visual assessment of the mid-face area. - Current cutaneous inflammatory or infectious processes (e.g., acne, herpes), abscess, unhealed wound, or cancerous or precancerous lesion on the face.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1: NOA VOLUME |
Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18. |
|
|
Experimental Cohort 1: VOLUMA XC |
Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18. |
|
|
Experimental Cohort 2: NOA VOLUME |
Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and at either Month 12, 15, or 18. |
|
|
Experimental Cohort 2: VOLUMA XC |
Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and at either Month 12, 15, or 18. |
|
Recruiting Locations
Coral Gables, Florida 33146-1837
Metairie, Louisiana 70001
Baltimore, Maryland 21208-6391
Austin, Texas 78746-4720
More Details
- NCT ID
- NCT06734351
- Status
- Recruiting
- Sponsor
- AbbVie