drugset
drugset / Trial / NCT05386030

Saypha® VOLUME Lidocaine for Midface Augmentation

NCT05386030 ↗

Phase 3 Completed 562 enrolled Croma-Pharma GmbH
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2022-08-16
Primary completion
2023-10-04
Completion
2024-12-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Juvéderm® Voluma™ XC Unknown 0.3 % Other
Subject Juvéderm® Voluma™ XC Unknown 20 mg/ml Other
Subject saypha® VOLUME Lidocaine Unknown 0.3 % Other
Subject saypha® VOLUME Lidocaine Unknown 23 mg/ml Other

Indications

midface dysplasia