A Study to Evaluate Safety and Effectiveness of NOA VOLUME Injectable Gel in Adult Partici
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
| Condition(s) | Mid Face Volume Deficit |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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 w |
| Who can participate | 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. |
| Ages | 22 Years |
| Sex | All |
| Lead sponsor | AbbVie |
| Locations | Birmingham, Alabama, United States; Glendale, Arizona, United States; San Diego, California, United States; Bradenton, Florida, United States; Coral Gables, Florida, United States; Coral Gables, Florida, United States (+8 more sites) |
| Start date | 2024-12-16 |
| NCT ID | NCT06734351 |
| Official listing | https://clinicaltrials.gov/study/NCT06734351 |