Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06734351 | 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 | PHASE3 | RECRUITING | 231 | — | — | Dec 16, 2024 | Jul 1, 2029 | Jun 4, 2026 | 14 | United States |
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).
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: NOA VOLUME | EXPERIMENTAL | Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18. |
| Cohort 1: VOLUMA XC | EXPERIMENTAL | Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18. |
| Cohort 2: NOA VOLUME | EXPERIMENTAL | Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18. |
| Cohort 2: VOLUMA XC | EXPERIMENTAL | Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18. |
| Name | Type | Description |
|---|---|---|
| NOA VOLUME | DEVICE | Injections |
| VOLUMA XC | DEVICE | Injections |
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 volu...