Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NOA VOLUME, VOLUMA XC · 1 trial · 1 indication
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...
NOA VOLUME, VOLUMA XC is an injectable gel being studied for the improvement of mid-face volume deficit in adults. It is currently in Phase 3 clinical development and is not yet approved by the FDA. The product is being evaluated for safety and effectiveness in a clinical trial setting.
NOA VOLUME, VOLUMA XC is being developed by AbbVie Inc., which trades under the ticker symbol ABBV. The company is conducting a Phase 3 clinical trial to evaluate the product's safety and effectiveness for mid-face volume deficit.
NOA VOLUME, VOLUMA XC is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The ongoing Phase 3 trial is recruiting participants to assess its safety and effectiveness for mid-face volume deficit.
NOA VOLUME, VOLUMA XC is being studied in a Phase 3 clinical trial with the identifier NCT06734351. This randomized, double-blind, controlled study is evaluating the safety and effectiveness of NOA VOLUME injectable gel compared to JUVÉDERM VOLUMA XC for improvement of mid-face volume in adults.
NOA VOLUME, VOLUMA XC is being studied in comparison to JUVÉDERM VOLUMA XC in a clinical trial. The trial is designed to evaluate whether NOA VOLUME is as safe and effective as JUVÉDERM VOLUMA XC for improving mid-face volume. They are distinct products being compared in the study.