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Saypha® VOLUME Lidocaine for Midface Augmentation

NCT05386030 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 562

Last updated 2026-04-09

Study results available
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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).

Conditions

  • Moderate to Severe Midface Volume Deficit

Interventions

COMBINATION_PRODUCT

saypha® VOLUME Lidocaine

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

COMBINATION_PRODUCT

Juvéderm® Voluma™ XC

Crosslinked HA 20 mg/mL + 0.3% lidocaine hydrochloride

Sponsors & Collaborators

  • Croma-Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Elyse S Rafal, MD · DermResearchCenter of New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-16
Primary Completion
2023-10-04
Completion
2024-12-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05386030 on ClinicalTrials.gov