CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 562 enrolled
Drug / intervention
saypha® VOLUME Lidocaine +1 morecombination
Likely dose
saypha® VOLUME Lidocaine 23 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05386030
NCT05386030Phase 3Completed
CompareCT.gov

A Randomized, Subject- and Evaluator-blinded, Controlled, Non-inferiority Multicenter, Parallel Group Comparison Study to Evaluate Effectiveness and Safety of Saypha® VOLUME Lidocaine for Midface Augmentation to Correct Volume Deficit

Croma-Pharma GmbH·interventional·Posted May 23, 2022·Updated Apr 9, 2026

In Brief

A Phase 3 clinical trial evaluating saypha® VOLUME Lidocaine and Juvéderm® Voluma™ XC for Moderate to Severe Midface Volume Deficit. Completed, enrolled 562 participants across 16 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate to Severe Midface Volume Deficit
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMay 23, 2022
Enrollment StartAug 16, 2022
Primary CompletionOct 4, 2023
Study CompletionDec 11, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.1 years ago

Interventions

saypha® VOLUME Lidocainecombination

Crosslinked hyaluronic acid (HA) 23 mg/mL + 0.3% lidocaine hydrochloride.

Juvéderm® Voluma™ XCcombination

Crosslinked HA 20 mg/mL + 0.3% lidocaine hydrochloride