NCT05386030

Saypha® VOLUME Lidocaine for Midface Augmentation

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 562 (actual)
• Sponsor: Croma-Pharma GmbH · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Accepted

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).

Detailed description

This will be a multi-center, randomized, double-blind, comparator-controlled study. The study took place in the US at 16 sites. The purpose of the current clinical investigation is to evaluate the effectiveness, safety and long-term safety of saypha® VOLUME Lidocaine for the correction of age-related moderate to severe volume deficit in the midface (augmentation of midface volume deficit), and to demonstrate its non-inferiority to one of the devices approved for the same indication (Juvéderm® Voluma™ XC). In addition, the duration of the aesthetic effect after implantation will be studied. Approximately 486 subjects in total will be randomized and treated resulting in 437 evaluable subjects for the primary endpoint. Randomization will be in a 2:1 ratio (test device: 324, comparator device: 162). Each subject will take part in the investigation for up to 92 weeks. The total anticipated duration of the investigation, from the first-subject-first visit to the last-subject-last-visit, is around 114 weeks, based on expected recruitment period of about 22 weeks.

Conditions

• Moderate to Severe Midface Volume Deficit

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-08-16
• Primary completion: 2023-10-04
• Completion: 2024-12-11
• First posted: 2022-05-23
• Last updated: 2026-04-09
• Results posted: 2025-01-16

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated device study