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NCT05386030 · ClinicalTrials.gov registry record · Phase 3
Saypha® VOLUME Lidocaine for Midface Augmentation
A Phase 3 study, sponsored by Croma-Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 562
- Enrollment target
NCT05386030: Completed Phase 3 study, sponsored by Croma-Pharma.
NCT05386030 is a Phase 3 study that has completed, run by Croma-Pharma. The registered enrollment target is 562 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05386030, a Phase 3 study, has completed, sponsored by Croma-Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 562 participants
- Enrollment target
Study Summary
The clinical investigation is a randomized, subject- and evaluator-blinded, active treatment controlled, multicenter, clinical investigation, to demonstrate the non inferiority of saypha® VOLUME Lidocaine to one of the devices approved for the same indication (Juvéderm® Voluma™ XC).
Primary Outcome
The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit) based on the blinded evaluator´s live assessment at Week 24 after last injection of initial treatment phase compared to the pre-treatment score at Baseline visit. Subjects are defined as responders if they are showing an \>=1 point improvement in MVDSS at Week 24 relative to baseline.
Interventions
- COMBINATION_PRODUCT saypha® VOLUME Lidocaine
- COMBINATION_PRODUCT Juvéderm® Voluma™ XC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 562 participants |
| Start Date | 2022-08-16 |
| Est. Completion | 2024-12-11 |
| Phase | Phase 3 |
What the finished NCT05386030 record still lists
NCT05386030 is an interventional study that assigns participants to a tested intervention. The registered 562 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which saypha® VOLUME Lidocaine is the first listed.
NCT05386030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05386030 about?
NCT05386030 is a clinical study titled "Saypha® VOLUME Lidocaine for Midface Augmentation". The clinical investigation is a randomized, subject- and evaluator-blinded, active treatment controlled, multicenter, clinical investigation, to demonstrate the non inferiority of saypha® VOLUME Lidocaine to one of the devices approved for the same indication (Juvéderm® Voluma™ XC).
What is the current status of trial NCT05386030?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 562 participants. The study started on 2022-08-16. Estimated completion is 2024-12-11.
What interventions are being tested in trial NCT05386030?
The interventions under investigation include: saypha® VOLUME Lidocaine (COMBINATION_PRODUCT), Juvéderm® Voluma™ XC (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05386030?
This trial is sponsored by Croma-Pharma, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05386030's enrollment target sits among peer trials
562 669th of 2000 higher than 1,331 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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